Shire HGT
Industry: Commercial company
DescriptionFounded: 1988 Parent organization: Shire Subsidiary: Premacure AB
Shire HGT List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at Shire HGT. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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Shire HGT Employees
Employee
Years
Job
Industry
nirja dahal nirja dahal's Shire HGT Experience May 2011 - Present
Job manufacturing technician at Shire HGT
Industry Biotechnology
Experience
Shire HGT May 2011 - Present
Sunrise Assisted Living November 2003 - May 2010
Skills
GMP, Sop, Cell Culture, cGMP manufacturing, UF/DF, Upstream Processing, Quality Control, LIMMS, GDP, Spectrophotometry, Microscopy, Titration, Batch Records, Compliance, Microbiology, Residential Care, Nursing Care, Trackwise, Microsoft Excel, Outlook, Microsoft Word, SOP, CAPA
Education
UMass Boston 2006 — 2010
bachelor's of science, Biology/Biological Sciences, General
Shire HGT May 2011 - Present
Sunrise Assisted Living November 2003 - May 2010
Skills
GMP, Sop, Cell Culture, cGMP manufacturing, UF/DF, Upstream Processing, Quality Control, LIMMS, GDP, Spectrophotometry, Microscopy, Titration, Batch Records, Compliance, Microbiology, Residential Care, Nursing Care, Trackwise, Microsoft Excel, Outlook, Microsoft Word, SOP, CAPA
Education
UMass Boston 2006 — 2010
bachelor's of science, Biology/Biological Sciences, General
David Whiteman MD David Whiteman MD's Shire HGT Experience August 2010 - July 2012
Job Global Clinical Sciences Leader, R&D at Shire
Industry Biotechnology
Experience
Shire Pharmaceuticals April 2015 - Present
Shire Pharmaceuticals July 2012 - April 2015
Shire HGT August 2010 - July 2012
Shire HGT August 2005 - August 2010
Skills
Rare Diseases, Drug Development, Orphan Drugs, Medical Affairs, Medicine, Clinical Research, Clinical Development, Biotechnology, Drug Discovery, Pharmaceutical Industry, R&D, Regulatory Submissions, Lifesciences, Clinical Trials, Biopharmaceuticals, Oncology, CRO, GCP, IND, Infectious Diseases, Medical Writing, CTMS, Hematology, Pharmacovigilance, Immunology, Therapeutic Areas, Biomarkers, Translational Medicine, Life Sciences
Education
Oxford University Medical School 1974 — 1978
B.M, B.Ch., Medicine and Surgery
Oxford University 1970 — 1974
BA, Biochemistry, Physiology and Experimental Psychology
Repton School 1960 — 1969
General Certificate of Education
Shire Pharmaceuticals April 2015 - Present
Shire Pharmaceuticals July 2012 - April 2015
Shire HGT August 2010 - July 2012
Shire HGT August 2005 - August 2010
Skills
Rare Diseases, Drug Development, Orphan Drugs, Medical Affairs, Medicine, Clinical Research, Clinical Development, Biotechnology, Drug Discovery, Pharmaceutical Industry, R&D, Regulatory Submissions, Lifesciences, Clinical Trials, Biopharmaceuticals, Oncology, CRO, GCP, IND, Infectious Diseases, Medical Writing, CTMS, Hematology, Pharmacovigilance, Immunology, Therapeutic Areas, Biomarkers, Translational Medicine, Life Sciences
Education
Oxford University Medical School 1974 — 1978
B.M, B.Ch., Medicine and Surgery
Oxford University 1970 — 1974
BA, Biochemistry, Physiology and Experimental Psychology
Repton School 1960 — 1969
General Certificate of Education
Mandy Rausch Mandy Rausch's Shire HGT Experience September 2005 - August 2008
Job Outreach and Social Media Coordinator at the University of North Texas; Theatre Performer/Director/Volunteer
Industry Higher Education
Experience
Sundown Collaborative Theatre January 2014 - Present
Denton Community Theatre June 1999 - Present
University of North Texas February 2015 - Present
University of North Texas October 2008 - February 2015
Music Theatre of Denton October 2004 - May 2014
Shire HGT September 2005 - August 2008
Skills
Acting, Singing, Editing, Event Planning, Social Media, Microsoft Office, PowerPoint, Public Speaking, Research, Event Management, Microsoft Word, Administrative..., Outlook, Technical Writing, Fundraising, Theatre, Copy Editing, Proofreading, Marketing
Education
University of North Texas 2000 — 2005
Bachelor of Arts, English
Sundown Collaborative Theatre January 2014 - Present
Denton Community Theatre June 1999 - Present
University of North Texas February 2015 - Present
University of North Texas October 2008 - February 2015
Music Theatre of Denton October 2004 - May 2014
Shire HGT September 2005 - August 2008
Skills
Acting, Singing, Editing, Event Planning, Social Media, Microsoft Office, PowerPoint, Public Speaking, Research, Event Management, Microsoft Word, Administrative..., Outlook, Technical Writing, Fundraising, Theatre, Copy Editing, Proofreading, Marketing
Education
University of North Texas 2000 — 2005
Bachelor of Arts, English
Ganga sharma's Shire HGT Experience January 2012 - October 2012
Job Biotechnologist
Industry Biotechnology
Experience
Boehringer Ingelheim March 2014 - Present
Shire HGT January 2012 - October 2012
Modular Genetics, Woburn MA November 2011 - January 2012
Stempeutics Research Pvt. Ltd. March 2008 - July 2008
Codon Devices January 2007 - January 2008
Genzyme Genetics May 2006 - December 2006
UMass Lowell January 2004 - May 2006
Centers for Learning January 2005 - January 2006
Skills
Cell Culture, PCR, Gel Electrophoresis, Protein Purification, Restriction Digestion, Ligation, Gel Extraction, ELISA, Western Blotting, SDS-PAGE, Biotechnology, Molecular Biology, DNA extraction, DNA, Tissue Culture, Lifesciences, Purification, Assay Development, Microbiology, HPLC, Biochemistry, Cell Biology, RNA isolation, qPCR, Spectrophotometry, High Throughput..., Flow Cytometry
Education
UMass Lowell 2003 — 2006
B.Sc., Biotechnology
University of Massachusetts 2002 — 2006
Bachelor of Science, Biotechnology
Boehringer Ingelheim March 2014 - Present
Shire HGT January 2012 - October 2012
Modular Genetics, Woburn MA November 2011 - January 2012
Stempeutics Research Pvt. Ltd. March 2008 - July 2008
Codon Devices January 2007 - January 2008
Genzyme Genetics May 2006 - December 2006
UMass Lowell January 2004 - May 2006
Centers for Learning January 2005 - January 2006
Skills
Cell Culture, PCR, Gel Electrophoresis, Protein Purification, Restriction Digestion, Ligation, Gel Extraction, ELISA, Western Blotting, SDS-PAGE, Biotechnology, Molecular Biology, DNA extraction, DNA, Tissue Culture, Lifesciences, Purification, Assay Development, Microbiology, HPLC, Biochemistry, Cell Biology, RNA isolation, qPCR, Spectrophotometry, High Throughput..., Flow Cytometry
Education
UMass Lowell 2003 — 2006
B.Sc., Biotechnology
University of Massachusetts 2002 — 2006
Bachelor of Science, Biotechnology
Alan Mann Alan Mann's Shire HGT Experience May 2012 - August 2012
Job Research Associate at Warp Drive Bio
Industry Biotechnology
Experience
Warp Drive Bio July 2013 - Present
Shire HGT May 2012 - August 2012
University of Massachusetts Amherst January 2012 - May 2012
University of Massachusetts Amherst 2012 - 2012
Education
University of Massachusetts, Amherst 2008 — 2012
Bachelor of Science, Chemical Engineering
Worcester Polytechnic Institute 2009 — 2009
Chemical Engineering
Warp Drive Bio July 2013 - Present
Shire HGT May 2012 - August 2012
University of Massachusetts Amherst January 2012 - May 2012
University of Massachusetts Amherst 2012 - 2012
Education
University of Massachusetts, Amherst 2008 — 2012
Bachelor of Science, Chemical Engineering
Worcester Polytechnic Institute 2009 — 2009
Chemical Engineering
Griffin Weigel Griffin Weigel's Shire HGT Experience February 2012 - June 2012
Job Research Assistant at The Forsyth Institute
Industry Biotechnology
Experience
The Forsyth Institute June 2012 - Present
Shire HGT February 2012 - June 2012
University of Connecticut January 2010 - January 2012
Education
The University of Connecticut 2006 — 2011
Bachelor of Science (BS), Cell/Cellular and Molecular Biology
The Forsyth Institute June 2012 - Present
Shire HGT February 2012 - June 2012
University of Connecticut January 2010 - January 2012
Education
The University of Connecticut 2006 — 2011
Bachelor of Science (BS), Cell/Cellular and Molecular Biology
Quang Vo Quang Vo's Shire HGT Experience August 2012 - Present
Job MTS Engineer II at Shire HGT
Industry Biotechnology
Experience
Shire HGT August 2012 - Present
Shire HGT October 2011 - August 2012
University of Massachusetts September 2010 - October 2011
Skills
Mammalian Cell Culture, Unit Operations, Six Sigma, Statistical Data..., Experimental Design, GxP, Filtration, Scale-up, Chemical Engineering, Technical Writing, Matlab, LIMS, Unicorn, JMP
Education
UMass Lowell 2010 — 2013
Master of Science (MS), Chemical Engineering
UMass Lowell 2006 — 2010
Bachelor of Science (BS), Chemical Engineering
Shire HGT August 2012 - Present
Shire HGT October 2011 - August 2012
University of Massachusetts September 2010 - October 2011
Skills
Mammalian Cell Culture, Unit Operations, Six Sigma, Statistical Data..., Experimental Design, GxP, Filtration, Scale-up, Chemical Engineering, Technical Writing, Matlab, LIMS, Unicorn, JMP
Education
UMass Lowell 2010 — 2013
Master of Science (MS), Chemical Engineering
UMass Lowell 2006 — 2010
Bachelor of Science (BS), Chemical Engineering
Norma Santana Norma Santana's Shire HGT Experience July 2010 - Present
Job Engineering Document Control Manager at Shire HGT
Industry Pharmaceuticals
Experience
Shire HGT July 2010 - Present
Shire HGT July 2008 - July 2010
Wyeth Biotech 1998 - 2008
Education
University of Massachusetts Lowell
Civil Engineering
Shire HGT July 2010 - Present
Shire HGT July 2008 - July 2010
Wyeth Biotech 1998 - 2008
Education
University of Massachusetts Lowell
Civil Engineering
Katie Geldart Katie Geldart's Shire HGT Experience 2010 - 2010
Job Student at University of Massachusetts
Industry Biotechnology
Experience
University of Massachusetts September 2008 - Present
Shire HGT 2010 - 2010
Education
University of Massachusetts, Amherst 2008 — 2012
Chemical Engineering, Chemical Engineering, concentration in Biochemical Engineering
University of Massachusetts September 2008 - Present
Shire HGT 2010 - 2010
Education
University of Massachusetts, Amherst 2008 — 2012
Chemical Engineering, Chemical Engineering, concentration in Biochemical Engineering
Lynne Menton Brennan Lynne Menton Brennan's Shire HGT Experience August 2007 - September 2011
Job
Industry Biotechnology
Experience
Shire HGT August 2007 - September 2011
Shire HGT March 2005 - March 2007
Transkaryotic Therapies March 2003 - March 2005
Transkaryotic Therapies 2002 - 2003
Transkaryotic Therapies 2001 - 2002
Transkaryotic Therapies August 1999 - 2001
Creative Biomolecules January 1997 - November 1998
Cambridge Biotech May 1996 - January 1997
Joint Center for Radiation Therapy (Harvard Medical/ MIT/ Deaconess Hospital) September 1993 - November 1995
Brigham and Women's Hospital July 1992 - April 1993
Skills
Quality Control..., Quality Systems..., OOS Investigations, Trackwise, CAPA, Deviations, Change Control, GMP Investigations, LIMS, SOP’s, QC Operations, Agency Inspection, Regulatory Submission, Equipment Validation, Instrument Validation, Investigational Studies, Analytical Method..., Method Transfer, PVR Studies, Training Delivery, Performance Metrics, Staff Development, Staff Performance, Coaching Staff, Positive Approach, Trustworthy, Biochemistry, GMP, Quality Control, Quality System, Regulatory Submissions, Performance Management, Validation, Aseptic Processing, GLP, Sop, Aseptic Technique, FDA, 21 CFR Part 11, Biopharmaceuticals, SOP, TrackWise
Education
University of Massachusetts Boston
Bachelor's Degree, Science, Biology
Shire HGT August 2007 - September 2011
Shire HGT March 2005 - March 2007
Transkaryotic Therapies March 2003 - March 2005
Transkaryotic Therapies 2002 - 2003
Transkaryotic Therapies 2001 - 2002
Transkaryotic Therapies August 1999 - 2001
Creative Biomolecules January 1997 - November 1998
Cambridge Biotech May 1996 - January 1997
Joint Center for Radiation Therapy (Harvard Medical/ MIT/ Deaconess Hospital) September 1993 - November 1995
Brigham and Women's Hospital July 1992 - April 1993
Skills
Quality Control..., Quality Systems..., OOS Investigations, Trackwise, CAPA, Deviations, Change Control, GMP Investigations, LIMS, SOP’s, QC Operations, Agency Inspection, Regulatory Submission, Equipment Validation, Instrument Validation, Investigational Studies, Analytical Method..., Method Transfer, PVR Studies, Training Delivery, Performance Metrics, Staff Development, Staff Performance, Coaching Staff, Positive Approach, Trustworthy, Biochemistry, GMP, Quality Control, Quality System, Regulatory Submissions, Performance Management, Validation, Aseptic Processing, GLP, Sop, Aseptic Technique, FDA, 21 CFR Part 11, Biopharmaceuticals, SOP, TrackWise
Education
University of Massachusetts Boston
Bachelor's Degree, Science, Biology
Jim Zhang Jim Zhang's Shire HGT Experience February 2009 - January 2011
Job Associate Director, Regulatory Operations at Daiichi Sankyo, Inc.
Industry Pharmaceuticals
Experience
Daiichi Sankyo, Inc. July 2015 - Present
Bayer HealthCare October 2014 - July 2015
Merck December 2012 - October 2014
Merck July 2012 - December 2012
Eisai February 2011 - July 2012
Shire HGT February 2009 - January 2011
CSC (formerly Image Solutions Inc.) October 2006 - January 2009
Sino Furnishings Inc. May 2004 - September 2006
Skills
Regulatory Affairs, Regulatory Submissions, eCTD, Document Management, Validation, Testing, 21 CFR Part 11, Computer System..., Quality Assurance, Documentum, Adobe Acrobat, Microsoft Office, Regulatory Requirements, Process Improvement, IND, Clinical Trials, FDA, Pharmaceutical Industry, Sop, Technology Transfer, SOP
Education
University of Northern Virginia 2002 — 2004
MS, Information Systems & Technology
Daiichi Sankyo, Inc. July 2015 - Present
Bayer HealthCare October 2014 - July 2015
Merck December 2012 - October 2014
Merck July 2012 - December 2012
Eisai February 2011 - July 2012
Shire HGT February 2009 - January 2011
CSC (formerly Image Solutions Inc.) October 2006 - January 2009
Sino Furnishings Inc. May 2004 - September 2006
Skills
Regulatory Affairs, Regulatory Submissions, eCTD, Document Management, Validation, Testing, 21 CFR Part 11, Computer System..., Quality Assurance, Documentum, Adobe Acrobat, Microsoft Office, Regulatory Requirements, Process Improvement, IND, Clinical Trials, FDA, Pharmaceutical Industry, Sop, Technology Transfer, SOP
Education
University of Northern Virginia 2002 — 2004
MS, Information Systems & Technology
Karen Held Karen Held's Shire HGT Experience 2005 - July 2008
Job Consultant at a Biopharmaceutical Company
Industry Pharmaceuticals
Experience
Life Science Construction Firm August 2010 - December 2010
Avecia August 2009 - November 2009
Shire HGT 2005 - July 2008
TKT 2001 - 2005
Wyeth 1996 - 1999
Skills
Biopharmaceuticals, Sop, Biotechnology, Risk Management, Software Documentation, Strategy, Project Management, CAPA, Quality Assurance, GMP, Technology Transfer, FDA, Pharmaceutical Industry, Change Control, 21 CFR Part 11, Management, SOP
Education
University of Massachusetts, Amherst 1985 — 1989
Life Science Construction Firm August 2010 - December 2010
Avecia August 2009 - November 2009
Shire HGT 2005 - July 2008
TKT 2001 - 2005
Wyeth 1996 - 1999
Skills
Biopharmaceuticals, Sop, Biotechnology, Risk Management, Software Documentation, Strategy, Project Management, CAPA, Quality Assurance, GMP, Technology Transfer, FDA, Pharmaceutical Industry, Change Control, 21 CFR Part 11, Management, SOP
Education
University of Massachusetts, Amherst 1985 — 1989
Carl Soderberg Carl Soderberg's Shire HGT Experience July 2011 - January 2014
Job Owner at Able Ebenezer Brewing Company | Military Officer & Veteran | Entrepreneur
Industry Biotechnology
Experience
The Able Ebenezer Brewing Company June 2014 - Present
Shire HGT July 2011 - January 2014
US Army November 2010 - July 2011
US Army September 2009 - November 2010
US Army September 2008 - September 2009
US Army September 2007 - September 2008
University of New Haven December 2005 - May 2007
Skills
Brewing, Biotechnology, Cross-functional Team..., Engineering, Team Leadership, Aseptic Technique, Leadership, Training, Quality System, Sales Management, Manufacturing, Public Speaking, Operations Management, Strategic Planning, GMP, Quality Assurance, FDA, Craft Beer, Aseptic Processing, Cell Culture, Leadership Development, Welding, Situational Leadership, Process Improvement, Biopharmaceuticals, Team Building, Project Planning, Program Management, Writing, Presentations, Investigation
Education
Tufts University 2012 — 2015
Master of Science (MS), Biotechnology Engineering
University of Rhode Island 2012 — 2012
Certificate, DFF/TFF Principles
University of New Haven 2003 — 2007
BS, Criminal Investigations
The Able Ebenezer Brewing Company June 2014 - Present
Shire HGT July 2011 - January 2014
US Army November 2010 - July 2011
US Army September 2009 - November 2010
US Army September 2008 - September 2009
US Army September 2007 - September 2008
University of New Haven December 2005 - May 2007
Skills
Brewing, Biotechnology, Cross-functional Team..., Engineering, Team Leadership, Aseptic Technique, Leadership, Training, Quality System, Sales Management, Manufacturing, Public Speaking, Operations Management, Strategic Planning, GMP, Quality Assurance, FDA, Craft Beer, Aseptic Processing, Cell Culture, Leadership Development, Welding, Situational Leadership, Process Improvement, Biopharmaceuticals, Team Building, Project Planning, Program Management, Writing, Presentations, Investigation
Education
Tufts University 2012 — 2015
Master of Science (MS), Biotechnology Engineering
University of Rhode Island 2012 — 2012
Certificate, DFF/TFF Principles
University of New Haven 2003 — 2007
BS, Criminal Investigations
Blair Robertson Blair Robertson's Shire HGT Experience May 2009 - July 2011
Job Senior Director, Global Hemophilia Marketing at Baxter International Inc.
Industry Pharmaceuticals
Experience
Baxalta May 2014 - Present
Cambridge BioMarketing August 2013 - April 2014
Cambrooke Therapeutics July 2011 - July 2013
Shire HGT May 2009 - July 2011
Bayer Healthcare January 2007 - April 2009
Bayer Healthcare January 2006 - January 2007
Abbott April 2003 - December 2005
Bayer April 1999 - March 2003
University of South Alabama March 1995 - March 1998
University of Oxford 1988 - 1991
Skills
Anti-infectives, Cross-functional Team..., Biotechnology, Pharmaceuticals, Clinical Development, Infectious Diseases, Strategic Planning, Marketing Strategy, Product Development, Global Marketing, Pharmaceutical Industry, Lifesciences, Medicine, Global Alliance..., Portfolio Management, Sales Management, Product Launch, Medical Nutrition..., Clinical Nutrition, Food & Beverage, Cardiovascular Medicine, orphan diseases, CCO, Global Strategy, Medical Affairs, Commercialization, Strategy, Clinical Trials, Competitive Analysis, Rare Diseases, International Marketing, Medical Devices, Pharmaceutical Sales, Oncology, Managed Care, Biopharmaceuticals, Sales Effectiveness, Market Access, Strategic Partnerships, Drug Development, Dermatology, Cardiology, Diabetes, Hospital Sales, Endocrinology, Biologics, Gastroenterology, Therapeutic Areas, Hematology, Vaccines
Education
University of Oxford 1989 — 1992
D.Phil, Physiology
University of Otago 1986 — 1989
Bsc (Hons) 1st class, Physiology
University of New Haven 2002 — 2003
MBA, Business Administration and Management, General
Baxalta May 2014 - Present
Cambridge BioMarketing August 2013 - April 2014
Cambrooke Therapeutics July 2011 - July 2013
Shire HGT May 2009 - July 2011
Bayer Healthcare January 2007 - April 2009
Bayer Healthcare January 2006 - January 2007
Abbott April 2003 - December 2005
Bayer April 1999 - March 2003
University of South Alabama March 1995 - March 1998
University of Oxford 1988 - 1991
Skills
Anti-infectives, Cross-functional Team..., Biotechnology, Pharmaceuticals, Clinical Development, Infectious Diseases, Strategic Planning, Marketing Strategy, Product Development, Global Marketing, Pharmaceutical Industry, Lifesciences, Medicine, Global Alliance..., Portfolio Management, Sales Management, Product Launch, Medical Nutrition..., Clinical Nutrition, Food & Beverage, Cardiovascular Medicine, orphan diseases, CCO, Global Strategy, Medical Affairs, Commercialization, Strategy, Clinical Trials, Competitive Analysis, Rare Diseases, International Marketing, Medical Devices, Pharmaceutical Sales, Oncology, Managed Care, Biopharmaceuticals, Sales Effectiveness, Market Access, Strategic Partnerships, Drug Development, Dermatology, Cardiology, Diabetes, Hospital Sales, Endocrinology, Biologics, Gastroenterology, Therapeutic Areas, Hematology, Vaccines
Education
University of Oxford 1989 — 1992
D.Phil, Physiology
University of Otago 1986 — 1989
Bsc (Hons) 1st class, Physiology
University of New Haven 2002 — 2003
MBA, Business Administration and Management, General
Eduart Golloshi Eduart Golloshi's Shire HGT Experience August 2009 - August 2012
Job Manufacturing Supervisor at Shire Pharmaceuticals
Industry Biotechnology
Experience
Shire Pharmaceuticals March 2012 - Present
Shire HGT August 2009 - August 2012
OmniGuide 2006 - 2009
Skills
Biopharmaceuticals, Biotechnology, CAPA, FDA, GMP, Pharmaceutical Industry, Technology Transfer, Validation
Education
University of Massachusetts Boston 2000 — 2005
BS, Biochemistry
Shire Pharmaceuticals March 2012 - Present
Shire HGT August 2009 - August 2012
OmniGuide 2006 - 2009
Skills
Biopharmaceuticals, Biotechnology, CAPA, FDA, GMP, Pharmaceutical Industry, Technology Transfer, Validation
Education
University of Massachusetts Boston 2000 — 2005
BS, Biochemistry
Shana Bouvier Shana Bouvier's Shire HGT Experience April 2013 - Present
Job Lead Investigator at Shire HGT
Industry Pharmaceuticals
Experience
Shire HGT April 2013 - Present
Shire Pharmaceuticals October 2012 - Present
Shire Pharmaceuticals May 2010 - October 2012
Skills
GMP, UF, Manufacturing, LIMS, Media Preparation, solution preparation, Trackwise, Quality System, FDA, Microbiology, Solutions Marketing, Pharmaceutical Industry, Technology Transfer, Ultrafiltration, Validation
Education
University of New Hampshire 2006 — 2010
Bachelors of Science, Microbiology
Haverhill High School
Shire HGT April 2013 - Present
Shire Pharmaceuticals October 2012 - Present
Shire Pharmaceuticals May 2010 - October 2012
Skills
GMP, UF, Manufacturing, LIMS, Media Preparation, solution preparation, Trackwise, Quality System, FDA, Microbiology, Solutions Marketing, Pharmaceutical Industry, Technology Transfer, Ultrafiltration, Validation
Education
University of New Hampshire 2006 — 2010
Bachelors of Science, Microbiology
Haverhill High School
Kristin Hamilton Kristin Hamilton's Shire HGT Experience January 2012 - Present
Job Sr Administrative Asst/Records Coordinator, Shire
Industry Biotechnology
Experience
Shire HGT January 2012 - Present
Pfizer June 2009 - December 2011
Wyeth December 2002 - June 2009
Skills
Pharmaceutical Industry, Sop, Biotechnology, GMP, Document Management, SAP, SharePoint, Quality System, Microsoft Excel, Microsoft Office, Customer Service, Project Management, Visio, Outlook, Microsoft Word, PowerPoint
Education
University of Massachusetts at Lowell 1996 — 2000
Bachelor's degree
Shire HGT January 2012 - Present
Pfizer June 2009 - December 2011
Wyeth December 2002 - June 2009
Skills
Pharmaceutical Industry, Sop, Biotechnology, GMP, Document Management, SAP, SharePoint, Quality System, Microsoft Excel, Microsoft Office, Customer Service, Project Management, Visio, Outlook, Microsoft Word, PowerPoint
Education
University of Massachusetts at Lowell 1996 — 2000
Bachelor's degree
Matthew Camelio Matthew Camelio's Shire HGT Experience 2006 - 2009
Job Manager, Engineering Commissioning and Qualification at Sanofi Pasteur
Industry Biotechnology
Experience
Sanofi Pasteur November 2009 - Present
EMD Serono March 2009 - December 2009
Shire HGT 2006 - 2009
Transkaryotic Therapies, Inc. 2002 - 2006
Organogenesis, Inc. 2000 - 2002
Anika Therapeutics 1998 - 2000
Genzyme Corporation 1992 - 1998
Education
University of New Hampshire 1988 — 1992
BS, Chemical Engineering
Sanofi Pasteur November 2009 - Present
EMD Serono March 2009 - December 2009
Shire HGT 2006 - 2009
Transkaryotic Therapies, Inc. 2002 - 2006
Organogenesis, Inc. 2000 - 2002
Anika Therapeutics 1998 - 2000
Genzyme Corporation 1992 - 1998
Education
University of New Hampshire 1988 — 1992
BS, Chemical Engineering
Eugene Nebelitsky Eugene Nebelitsky's Shire HGT Experience May 2006 - May 2009
Job Senior Scientist, Integrated Biologics Profiling Novartis Institutes for Biomedical Research
Industry Biotechnology
Experience
Novartis Biologics June 2009 - Present
Shire HGT May 2006 - May 2009
Education
Tufts University 2007 — 2010
Master of Engineering (currently enrolled), Biomedical Engineering
Tufts University 2005 — 2009
Graduate Certificates, Biotechnology Engineering & Bioengineering
Tufts University 2003 — 2005
Master of Science, Chemistry
University of Massachusetts Boston 1996 — 2000
Bachelor of Science, Biology
Novartis Biologics June 2009 - Present
Shire HGT May 2006 - May 2009
Education
Tufts University 2007 — 2010
Master of Engineering (currently enrolled), Biomedical Engineering
Tufts University 2005 — 2009
Graduate Certificates, Biotechnology Engineering & Bioengineering
Tufts University 2003 — 2005
Master of Science, Chemistry
University of Massachusetts Boston 1996 — 2000
Bachelor of Science, Biology
Judy Kolessar Judy Kolessar's Shire HGT Experience September 2009 - January 2010
Job RETIRED HR Professional
Industry Human Resources
Experience
DanaFilms, Inc. October 2010 - May 2012
Shire HGT September 2009 - January 2010
The Suburban Group 2008 - 2009
AstraZeneca 1984 - 2008
American Life Insurance Company 1979 - 1983
Farmers Bank of the State of Delaware 1975 - 1979
Skills
Mergers, Employee Relations, Personnel Management, Employee Benefits, Mergers & Acquisitions, Strategy, Team Building, Leadership, Deferred Compensation, Human Resources, Management, Strategic Planning, Training, Change Management, Program Management, Manufacturing, HR Policies, Leadership Development
Education
University of Delaware 1970 — 1977
Bachelor of Science, Business Education
DanaFilms, Inc. October 2010 - May 2012
Shire HGT September 2009 - January 2010
The Suburban Group 2008 - 2009
AstraZeneca 1984 - 2008
American Life Insurance Company 1979 - 1983
Farmers Bank of the State of Delaware 1975 - 1979
Skills
Mergers, Employee Relations, Personnel Management, Employee Benefits, Mergers & Acquisitions, Strategy, Team Building, Leadership, Deferred Compensation, Human Resources, Management, Strategic Planning, Training, Change Management, Program Management, Manufacturing, HR Policies, Leadership Development
Education
University of Delaware 1970 — 1977
Bachelor of Science, Business Education
Wendell Refior Wendell Refior's Shire HGT Experience 2005 - 2011
Job Professional Services
Industry Pharmaceuticals
Experience
DataCeutics, Inc. July 2011 - Present
EmersonLive.com May 2003 - Present
Shire HGT 2005 - 2011
Boston Scientific 2000 - 2005
Biogen Idec 1998 - 2000
Unum 1994 - 1998
Unum 1988 - 1994
NSTAR 1986 - 1988
Education
The University of Connecticut 1978 — 1980
MS, Statistics
DataCeutics, Inc. July 2011 - Present
EmersonLive.com May 2003 - Present
Shire HGT 2005 - 2011
Boston Scientific 2000 - 2005
Biogen Idec 1998 - 2000
Unum 1994 - 1998
Unum 1988 - 1994
NSTAR 1986 - 1988
Education
The University of Connecticut 1978 — 1980
MS, Statistics
Irene Aquino's Shire HGT Experience May 2011 - January 2013
Job Director, Patient Advocacy and Engagement
Industry Biotechnology
Experience
Alnylam Pharmaceuticals June 2015 - Present
Biogen January 2013 - June 2015
Shire HGT May 2011 - January 2013
EMD Serono April 2008 - May 2011
EMD Serono April 2006 - April 2008
EMD Serono September 2004 - March 2006
sanofi-aventis December 1998 - September 2004
sanofi-aventis August 1996 - November 1998
Retail 1991 - 1997
Restaurants Unlimited 1990 - 1996
Skills
Pharmaceutical Sales, Pharmaceutical Industry, Market Research, Neurology, Biotechnology, Product Launch, Hospital Sales, Digital Strategy, Segmentation, Marketing, Sales Effectiveness, Market Access, Biologics, Commercialization, Biopharmaceuticals, Strategy, Cross-functional Team...
Education
University of Hawaii John A. Burns School of Medicine 1986 — 1990
Alnylam Pharmaceuticals June 2015 - Present
Biogen January 2013 - June 2015
Shire HGT May 2011 - January 2013
EMD Serono April 2008 - May 2011
EMD Serono April 2006 - April 2008
EMD Serono September 2004 - March 2006
sanofi-aventis December 1998 - September 2004
sanofi-aventis August 1996 - November 1998
Retail 1991 - 1997
Restaurants Unlimited 1990 - 1996
Skills
Pharmaceutical Sales, Pharmaceutical Industry, Market Research, Neurology, Biotechnology, Product Launch, Hospital Sales, Digital Strategy, Segmentation, Marketing, Sales Effectiveness, Market Access, Biologics, Commercialization, Biopharmaceuticals, Strategy, Cross-functional Team...
Education
University of Hawaii John A. Burns School of Medicine 1986 — 1990
Kathy Harnett Kathy Harnett's Shire HGT Experience December 2009 - August 2010
Job Statistical Programmer Consultant
Industry Pharmaceuticals
Experience
Independent Consultant September 2011 - Present
Foldrx Pharmaceuticals September 2010 - September 2011
Shire HGT December 2009 - August 2010
Indevus Pharmaceuticals May 2007 - December 2009
BattelleCRO 2006 - 2007
AAIPharma Services Corp. 2000 - 2001
PAREXEL September 1992 - May 1997
UMass Lowell 1991 - 1992
Blue Cross Blue Shield 1988 - 1991
Education
University of Massachusetts Lowell 1991 — 1994
MS, Statistics
University of New Hampshire 1983 — 1987
BS, Math/Statistics
Independent Consultant September 2011 - Present
Foldrx Pharmaceuticals September 2010 - September 2011
Shire HGT December 2009 - August 2010
Indevus Pharmaceuticals May 2007 - December 2009
BattelleCRO 2006 - 2007
AAIPharma Services Corp. 2000 - 2001
PAREXEL September 1992 - May 1997
UMass Lowell 1991 - 1992
Blue Cross Blue Shield 1988 - 1991
Education
University of Massachusetts Lowell 1991 — 1994
MS, Statistics
University of New Hampshire 1983 — 1987
BS, Math/Statistics
Chris Riel Chris Riel's Shire HGT Experience October 2010 - February 2014
Job Director Quality Assurance at Voyager Therapeutics, Inc.
Industry Biotechnology
Experience
Voyager Therapeutics, Inc. February 2015 - Present
Complya Consulting Group August 2014 - January 2015
Shire HGT October 2010 - February 2014
Shire HGT September 2010 - October 2010
Pfizer (Formerly Wyeth) January 2002 - April 2010
Wyeth January 2001 - January 2002
Wyeth (Formerly Genetics Institute, Inc.) January 1998 - January 2001
Genetics Institute, Inc. January 1988 - January 1998
Baxter Healthcare 1986 - 1988
Baxter Healthcare 1985 - 1986
Skills
Biopharmaceuticals, Quality Control, Quality System, Quality Auditing, FDA, Cross-functional Team..., GMP, Biotechnology, Leadership, Quality Assurance, Project Management, 21 CFR Part 11, Pharmaceutical Industry, Technology Transfer, Product Development, Manufacturing, Sop, Drug Development
Education
University of Rhode Island
Bachelor of Science Pharmacy
Voyager Therapeutics, Inc. February 2015 - Present
Complya Consulting Group August 2014 - January 2015
Shire HGT October 2010 - February 2014
Shire HGT September 2010 - October 2010
Pfizer (Formerly Wyeth) January 2002 - April 2010
Wyeth January 2001 - January 2002
Wyeth (Formerly Genetics Institute, Inc.) January 1998 - January 2001
Genetics Institute, Inc. January 1988 - January 1998
Baxter Healthcare 1986 - 1988
Baxter Healthcare 1985 - 1986
Skills
Biopharmaceuticals, Quality Control, Quality System, Quality Auditing, FDA, Cross-functional Team..., GMP, Biotechnology, Leadership, Quality Assurance, Project Management, 21 CFR Part 11, Pharmaceutical Industry, Technology Transfer, Product Development, Manufacturing, Sop, Drug Development
Education
University of Rhode Island
Bachelor of Science Pharmacy
KEVIN BLASCHAK KEVIN BLASCHAK's Shire HGT Experience August 2007 - January 2009
Job Database Administrator at PNC
Industry Information Technology and Services
Experience
PNC July 2011 - Present
Ceiba Solutions February 2009 - February 2011
Shire HGT August 2007 - January 2009
CDC Software June 1996 - July 2007
SCHOTT July 1994 - June 1996
Wheeling Pittsburgh Steel Corp April 1991 - June 1994
Consolidated Alumin May 1989 - March 1991
Skills
Business Intelligence, ERP, Microsoft SQL Server, Integration, Databases, Requirements Analysis, Linux, Data Migration, Software Development, Business Process, Visual Basic, Troubleshooting, Oracle, Disaster Recovery, Project Management, Software Project..., Program Management, Servers, Solaris, SDLC, SQL, SharePoint, Enterprise Architecture
Education
University of Essex 1979 — 1981
BSc (Hons), PHYSICS, Electrical Engineering
St Andrews RC High School, Kirkcaldy, Fife 1972 — 1974
Ordinary Level, Mathematics. Physics. Mechanics, Chemistry.
PNC July 2011 - Present
Ceiba Solutions February 2009 - February 2011
Shire HGT August 2007 - January 2009
CDC Software June 1996 - July 2007
SCHOTT July 1994 - June 1996
Wheeling Pittsburgh Steel Corp April 1991 - June 1994
Consolidated Alumin May 1989 - March 1991
Skills
Business Intelligence, ERP, Microsoft SQL Server, Integration, Databases, Requirements Analysis, Linux, Data Migration, Software Development, Business Process, Visual Basic, Troubleshooting, Oracle, Disaster Recovery, Project Management, Software Project..., Program Management, Servers, Solaris, SDLC, SQL, SharePoint, Enterprise Architecture
Education
University of Essex 1979 — 1981
BSc (Hons), PHYSICS, Electrical Engineering
St Andrews RC High School, Kirkcaldy, Fife 1972 — 1974
Ordinary Level, Mathematics. Physics. Mechanics, Chemistry.
JianJian Wang JianJian Wang's Shire HGT Experience 2008 - July 2010
Job Independent SAS Contractor
Industry Biotechnology
Experience
Cytel August 2010 - November 2014
Shire HGT 2008 - July 2010
Synta Pharmaceuticals September 2006 - April 2008
Biogen Idec February 2003 - September 2006
Transkaryotic Therapies, Inc., October 2000 - January 2003
PAREXEL September 1995 - November 2000
Genzyme June 1997 - March 1998
Education
University of Massachusetts, Amherst 1993 — 1995
M.S., Biostatistics
Fudan University, Shanghai, P.R.China 1986 — 1990
BA, Corporate Law
Cytel August 2010 - November 2014
Shire HGT 2008 - July 2010
Synta Pharmaceuticals September 2006 - April 2008
Biogen Idec February 2003 - September 2006
Transkaryotic Therapies, Inc., October 2000 - January 2003
PAREXEL September 1995 - November 2000
Genzyme June 1997 - March 1998
Education
University of Massachusetts, Amherst 1993 — 1995
M.S., Biostatistics
Fudan University, Shanghai, P.R.China 1986 — 1990
BA, Corporate Law
Warren Jaworowicz Warren Jaworowicz's Shire HGT Experience 2012 - 2014
Job Director of Technical Services at OvaScience
Industry Biotechnology
Experience
OvaScience April 2015 - Present
Shire Pharmaceuticals January 2014 - April 2015
Shire HGT 2012 - 2014
Stryker Regenerative Medicine July 2010 - April 2012
AVEO Pharmaceuticals 2012 - 2012
Stryker Biotech October 2005 - August 2009
Oscient Pharmaceuticals July 2004 - October 2005
Alkermes 1993 - 2004
Skills
Biotechnology, Pharmaceutical..., R&D, Technology Transfer, Process Development, Formulation Development, Drug Delivery, Protein Purification, Pharmaceuticals, Regulatory Submissions, Manufacturing, Pharmaceutical Industry, Process Simulation, CMC, IND, Formulation, V&V, Assay Development, Protein Chemistry, Product Development, HPLC, Drug Development, Biopharmaceuticals, Validation
Education
University of Michigan 1988 — 1993
OvaScience April 2015 - Present
Shire Pharmaceuticals January 2014 - April 2015
Shire HGT 2012 - 2014
Stryker Regenerative Medicine July 2010 - April 2012
AVEO Pharmaceuticals 2012 - 2012
Stryker Biotech October 2005 - August 2009
Oscient Pharmaceuticals July 2004 - October 2005
Alkermes 1993 - 2004
Skills
Biotechnology, Pharmaceutical..., R&D, Technology Transfer, Process Development, Formulation Development, Drug Delivery, Protein Purification, Pharmaceuticals, Regulatory Submissions, Manufacturing, Pharmaceutical Industry, Process Simulation, CMC, IND, Formulation, V&V, Assay Development, Protein Chemistry, Product Development, HPLC, Drug Development, Biopharmaceuticals, Validation
Education
University of Michigan 1988 — 1993
Christine Gebski Christine Gebski's Shire HGT Experience October 1999 - October 2001
Job Vice President, Product Management and Field Applications at Repligen Corporation
Industry Biotechnology
Experience
Repligen Corporation June 2015 - Present
Consultant - Biotechnology Professional November 2014 - May 2015
Thermo Fisher Scientific (Life Technologies) October 2011 - November 2014
Applied Biosystems/LIFE Technologies October 2004 - July 2012
EMD Pharmaceuticals November 2001 - October 2004
Shire HGT October 1999 - October 2001
Genzyme June 1989 - October 1999
Skills
Downstream Processing, Chromatography, Purification, Biotechnology, Biopharmaceuticals, Technology Transfer, Process Development, Protein Chemistry, BioChromatography, Troubleshooting, Assay Development, HPLC, GMP, Validation, Biochemistry, Protein Purification, Lifesciences, Cell Culture, ELISA, Product Development, Introducing New Products, Business Planning, P&L Management, Forecasting, Strategic Planning, Technical Writing, Technical Training, Cross-functional Team..., Life Sciences, Genomics, Process Simulation, Chemistry, LIMS, Mass Spectrometry, Characterization, R&D
Education
University of Massachusetts Lowell 1991 — 1994
Masters, Biotechnology
University of Vermont 1985 — 1989
BS, Biology
Repligen Corporation June 2015 - Present
Consultant - Biotechnology Professional November 2014 - May 2015
Thermo Fisher Scientific (Life Technologies) October 2011 - November 2014
Applied Biosystems/LIFE Technologies October 2004 - July 2012
EMD Pharmaceuticals November 2001 - October 2004
Shire HGT October 1999 - October 2001
Genzyme June 1989 - October 1999
Skills
Downstream Processing, Chromatography, Purification, Biotechnology, Biopharmaceuticals, Technology Transfer, Process Development, Protein Chemistry, BioChromatography, Troubleshooting, Assay Development, HPLC, GMP, Validation, Biochemistry, Protein Purification, Lifesciences, Cell Culture, ELISA, Product Development, Introducing New Products, Business Planning, P&L Management, Forecasting, Strategic Planning, Technical Writing, Technical Training, Cross-functional Team..., Life Sciences, Genomics, Process Simulation, Chemistry, LIMS, Mass Spectrometry, Characterization, R&D
Education
University of Massachusetts Lowell 1991 — 1994
Masters, Biotechnology
University of Vermont 1985 — 1989
BS, Biology
Jane Jacques Jane Jacques's Shire HGT Experience April 2012 - June 2014
Job Research Associate at Galenea
Industry Research
Experience
Galenea July 2014 - Present
Shire HGT April 2012 - June 2014
UL-STR May 2011 - April 2012
Underwriters Laboratories October 2010 - December 2010
Massachusetts General Hospital 2006 - 2008
Skills
ELISA, Cell Culture, Chemistry, Leadership, Laboratory, Spectrophotometry, Microscopy, UV/Vis, Assay Development, NMR, Research
Education
University of Massachusetts Lowell 2005 — 2010
Bachelors, Chemistry
Medford High School 2001 — 2005
High School Dipolma
Galenea July 2014 - Present
Shire HGT April 2012 - June 2014
UL-STR May 2011 - April 2012
Underwriters Laboratories October 2010 - December 2010
Massachusetts General Hospital 2006 - 2008
Skills
ELISA, Cell Culture, Chemistry, Leadership, Laboratory, Spectrophotometry, Microscopy, UV/Vis, Assay Development, NMR, Research
Education
University of Massachusetts Lowell 2005 — 2010
Bachelors, Chemistry
Medford High School 2001 — 2005
High School Dipolma
Pavel Dobrovolskiy - Wynes Pavel Dobrovolskiy - Wynes's Shire HGT Experience March 2009 - Present
Job at
Industry Biotechnology
Experience
Genzyme April 2014 - Present
Shire HGT March 2009 - Present
Shire HGT April 2009 - April 2014
Rapid Sheet Metal Inc. April 2007 - March 2008
Skills
Purification
Education
University of Phoenix 2011 — 2015
Business
Genzyme April 2014 - Present
Shire HGT March 2009 - Present
Shire HGT April 2009 - April 2014
Rapid Sheet Metal Inc. April 2007 - March 2008
Skills
Purification
Education
University of Phoenix 2011 — 2015
Business
Christopher Demopoulos Christopher Demopoulos's Shire HGT Experience June 2009 - August 2009
Job Research Associate II at Alkermes
Industry Pharmaceuticals
Experience
Alkermes April 2011 - Present
Shire HGT June 2009 - August 2009
Skills
Karl Fisher, HPLC, Empower, LC-FTIR, Microbiology, Biohazard, Gel Electrophoresis, Bacterial Culturing, Streak Plating, MALDI-TOF, Analytical Chemistry, Analytical Methods..., GMP, Method Development, Validation, Dissolution Testing, Instron, Particle Size Analysis, Surface Area Analysis, Documentation Practices
Education
University of Massachusetts, Amherst 2006 — 2011
Bachelor of Science (B.S.), Food Science and Technology
Worcester Polytechnic Institute 2004 — 2005
Alkermes April 2011 - Present
Shire HGT June 2009 - August 2009
Skills
Karl Fisher, HPLC, Empower, LC-FTIR, Microbiology, Biohazard, Gel Electrophoresis, Bacterial Culturing, Streak Plating, MALDI-TOF, Analytical Chemistry, Analytical Methods..., GMP, Method Development, Validation, Dissolution Testing, Instron, Particle Size Analysis, Surface Area Analysis, Documentation Practices
Education
University of Massachusetts, Amherst 2006 — 2011
Bachelor of Science (B.S.), Food Science and Technology
Worcester Polytechnic Institute 2004 — 2005
Bill Sicard Bill Sicard's Shire HGT Experience April 2011 - August 2014
Job Manufacturing Supervisor at Shire HGT
Industry Biotechnology
Experience
Shire HGT April 2011 - August 2014
Lonza Biologics February 2009 - February 2011
Bionostics Inc. 2006 - 2008
Electrochem October 2004 - October 2006
Skills
Manufacturing, Validation, Logistics, Lean Manufacturing, GMP, Sop, CAPA, Purification, Technology Transfer, Cell Culture, Aseptic Processing, FDA, Quality System, Biopharmaceuticals, LIMS, Trackwise, Change Control, Biotechnology, V&V, 21 CFR Part 11, Chromatography, Pharmaceutical Industry, GLP, Contract Manufacturing, Filtration, Quality Control, Cleaning Validation, GxP, HPLC, Vaccines, Computer System..., Process Simulation, Microbiology, Lifesciences, Fermentation, Quality Assurance, Regulatory Affairs, ISO 13485, SOP development, R&D, Medical Devices, ISO, Root Cause Analysis, Protein Purification, Pharmaceutics, Design of Experiments, Aseptic Technique, Commercialization, Deviations, ELISA
Education
University of Massachusetts Dartmouth 1987 — 1990
Bachelor, Business Administration
Nashoba Regional High School 1982 — 1986
Shire HGT April 2011 - August 2014
Lonza Biologics February 2009 - February 2011
Bionostics Inc. 2006 - 2008
Electrochem October 2004 - October 2006
Skills
Manufacturing, Validation, Logistics, Lean Manufacturing, GMP, Sop, CAPA, Purification, Technology Transfer, Cell Culture, Aseptic Processing, FDA, Quality System, Biopharmaceuticals, LIMS, Trackwise, Change Control, Biotechnology, V&V, 21 CFR Part 11, Chromatography, Pharmaceutical Industry, GLP, Contract Manufacturing, Filtration, Quality Control, Cleaning Validation, GxP, HPLC, Vaccines, Computer System..., Process Simulation, Microbiology, Lifesciences, Fermentation, Quality Assurance, Regulatory Affairs, ISO 13485, SOP development, R&D, Medical Devices, ISO, Root Cause Analysis, Protein Purification, Pharmaceutics, Design of Experiments, Aseptic Technique, Commercialization, Deviations, ELISA
Education
University of Massachusetts Dartmouth 1987 — 1990
Bachelor, Business Administration
Nashoba Regional High School 1982 — 1986
Doug Gunzelmann's Shire HGT Experience January 2010 - January 2013
Job Senior Development Specialist at Shire
Industry Biotechnology
Experience
Shire January 2013 - Present
Shire HGT January 2010 - January 2013
Shire HGT March 2007 - January 2010
Abbott Bioresearch Center March 2005 - March 2007
Advocates, Inc. September 2003 - March 2005
Skills
Purification, Protein Purification, SDS-PAGE, Filtration, Downstream Processing, ELISA, High Throughput..., Biotechnology, Chromatography, TFF, Biopharmaceuticals, GMP, TECAN liquid handling, AKTA, Enzyme Assays, Depth Filtration, Report Writing, Design of Experiments, Pharmaceutical Industry, Mixed mode..., Ion Chromatography, Affinity Chromatography, viral clearance, UFDF, high throughput process..., parallel chromatograhpy, UNICORN, DOE, FMEA, Biology, Protein Assays, ERT, JMP, membrane chromatography, HTPD, Technology Transfer, Life Sciences, single pass TFF, CAPA
Education
University of Notre Dame 1999 — 2003
Bachelor’s Degree, Biological Sciences
Fairport High School, NY 1996 — 1999
Shire January 2013 - Present
Shire HGT January 2010 - January 2013
Shire HGT March 2007 - January 2010
Abbott Bioresearch Center March 2005 - March 2007
Advocates, Inc. September 2003 - March 2005
Skills
Purification, Protein Purification, SDS-PAGE, Filtration, Downstream Processing, ELISA, High Throughput..., Biotechnology, Chromatography, TFF, Biopharmaceuticals, GMP, TECAN liquid handling, AKTA, Enzyme Assays, Depth Filtration, Report Writing, Design of Experiments, Pharmaceutical Industry, Mixed mode..., Ion Chromatography, Affinity Chromatography, viral clearance, UFDF, high throughput process..., parallel chromatograhpy, UNICORN, DOE, FMEA, Biology, Protein Assays, ERT, JMP, membrane chromatography, HTPD, Technology Transfer, Life Sciences, single pass TFF, CAPA
Education
University of Notre Dame 1999 — 2003
Bachelor’s Degree, Biological Sciences
Fairport High School, NY 1996 — 1999
Hanhnhan (Nina) Nguyen Hanhnhan (Nina) Nguyen's Shire HGT Experience August 2012 - April 2015
Job Data Analyst at BristolMyers Squibb
Industry Biotechnology
Experience
SHIRE HGT August 2012 - April 2015
Shire Pharmaceuticals June 2010 - August 2012
SHIRE HGT July 2008 - June 2010
Skills
Pharmaceutical Industry, Pharmaceutical Sales, Clinical Development, Clinical Trials, Gastroenterology, Oncology, GMP, Neurology, Biotechnology, Sop, Sales Effectiveness, Regulatory Affairs, Market Access, Validation, Nephrology, Cardiology, Regulatory Submissions, FDA, Rheumatology, Diabetes
Education
Southern University of New Hampshire 2010 — 2013
Master of Business Administration (MBA)
University of Massachusetts, Amherst 2004 — 2008
Bachelor of Science (BS)
SHIRE HGT August 2012 - April 2015
Shire Pharmaceuticals June 2010 - August 2012
SHIRE HGT July 2008 - June 2010
Skills
Pharmaceutical Industry, Pharmaceutical Sales, Clinical Development, Clinical Trials, Gastroenterology, Oncology, GMP, Neurology, Biotechnology, Sop, Sales Effectiveness, Regulatory Affairs, Market Access, Validation, Nephrology, Cardiology, Regulatory Submissions, FDA, Rheumatology, Diabetes
Education
Southern University of New Hampshire 2010 — 2013
Master of Business Administration (MBA)
University of Massachusetts, Amherst 2004 — 2008
Bachelor of Science (BS)
Christopher Blackburn Christopher Blackburn's Shire HGT Experience December 2010 - August 2012
Job Associate Director Operations Validation at Genzyme, a sanofi company
Industry Biotechnology
Experience
Genzyme, a sanofi company November 2014 - Present
Genzyme, a sanofi company August 2012 - November 2014
Shire HGT December 2010 - August 2012
Shire HGT April 2009 - December 2010
Bristol-Myers Squibb August 2007 - April 2009
Genzyme Corporation October 2001 - August 2007
Genzyme Corporation April 1998 - October 2001
Skills
Validation, FMEA, Risk Management, Quality Assurance, Qualification, Change Management, People Management, Performance Management, Project Management, Technology Transfer, Quality System, CAPA, FDA, Process Improvement, GMP, Change Control, Management, Manufacturing, Biotechnology, Cleaning Validation, Software Documentation
Education
Union College 1993 — 1997
BA, Biology
Genzyme, a sanofi company November 2014 - Present
Genzyme, a sanofi company August 2012 - November 2014
Shire HGT December 2010 - August 2012
Shire HGT April 2009 - December 2010
Bristol-Myers Squibb August 2007 - April 2009
Genzyme Corporation October 2001 - August 2007
Genzyme Corporation April 1998 - October 2001
Skills
Validation, FMEA, Risk Management, Quality Assurance, Qualification, Change Management, People Management, Performance Management, Project Management, Technology Transfer, Quality System, CAPA, FDA, Process Improvement, GMP, Change Control, Management, Manufacturing, Biotechnology, Cleaning Validation, Software Documentation
Education
Union College 1993 — 1997
BA, Biology
Eric Thomas Bachli, Dipl.Brew's Shire HGT Experience January 2008 - January 2010
Job Brewer at Trillium Brewing Company
Industry Food & Beverages
Experience
Trillium Brewing Company August 2015 - Present
Craft Brew Alliance April 2014 - August 2015
Jack's Abby Brewing April 2013 - April 2013
Blue Hills Brewery March 2012 - January 2013
Barleycorn's Craft Brew April 2012 - December 2012
Craft Beer Cellar April 2012 - December 2012
Pfizer January 2010 - March 2012
Shire HGT January 2008 - January 2010
Boston Scientific Corporation June 2004 - January 2008
The CBR Institute for Biomedical Research, INC. June 2002 - June 2004
Education
University of California, Davis 2013 — 2013
Master Brewers Program, Brewing Science & Engineering, IBD Diploma in Brewing
Siebel Institute for Technology 2011 — 2012
WBA Associate in Brewing Technology, Brewing Sciences & Technology
Harvard University Extension School 2006 — 2008
Biotechnology
University of Massachusetts, Amherst 1999 — 2002
B.S., Animal Sciences and Biotechnology
Trillium Brewing Company August 2015 - Present
Craft Brew Alliance April 2014 - August 2015
Jack's Abby Brewing April 2013 - April 2013
Blue Hills Brewery March 2012 - January 2013
Barleycorn's Craft Brew April 2012 - December 2012
Craft Beer Cellar April 2012 - December 2012
Pfizer January 2010 - March 2012
Shire HGT January 2008 - January 2010
Boston Scientific Corporation June 2004 - January 2008
The CBR Institute for Biomedical Research, INC. June 2002 - June 2004
Education
University of California, Davis 2013 — 2013
Master Brewers Program, Brewing Science & Engineering, IBD Diploma in Brewing
Siebel Institute for Technology 2011 — 2012
WBA Associate in Brewing Technology, Brewing Sciences & Technology
Harvard University Extension School 2006 — 2008
Biotechnology
University of Massachusetts, Amherst 1999 — 2002
B.S., Animal Sciences and Biotechnology
Claudio Lavareda Santos Claudio Lavareda Santos's Shire HGT Experience September 2011 - July 2013
Job Experienced Medical Affairs Executive
Industry Pharmaceuticals
Experience
Currently targeting Senior Leadership roles in Medical Affairs July 2015 - Present
Shire International November 2013 - June 2015
Shire Pharmaceuticals August 2013 - November 2013
Shire HGT September 2011 - July 2013
Shire HGT February 2011 - September 2011
Shire HGT April 2010 - August 2011
Pfizer November 2009 - March 2010
Wyeth May 2003 - November 2009
The Janssen Pharmaceutical Companies of Johnson & Johnson 1994 - 2003
Skills
Pharmaceutical Sales, Pharmaceutical Industry, Regulatory Affairs, Medical Affairs, Biotechnology, Biopharmaceuticals, Crisis Management, Business Ethics, Demand Generation, Cross-functional Team..., Market Access, Product Launch, Oncology, Diabetes, Medicine, Clinical Research, Pharmacovigilance, Clinical Development, Healthcare, Dermatology, Clinical Trials, Neurology, Organizational...
Education
University of Sao Paulo, FIA 2005 — 2006
EMBA, Business Administration
Federal University of Sao Paulo, EPM 1984 — 1992
MD, Pediatrics
Currently targeting Senior Leadership roles in Medical Affairs July 2015 - Present
Shire International November 2013 - June 2015
Shire Pharmaceuticals August 2013 - November 2013
Shire HGT September 2011 - July 2013
Shire HGT February 2011 - September 2011
Shire HGT April 2010 - August 2011
Pfizer November 2009 - March 2010
Wyeth May 2003 - November 2009
The Janssen Pharmaceutical Companies of Johnson & Johnson 1994 - 2003
Skills
Pharmaceutical Sales, Pharmaceutical Industry, Regulatory Affairs, Medical Affairs, Biotechnology, Biopharmaceuticals, Crisis Management, Business Ethics, Demand Generation, Cross-functional Team..., Market Access, Product Launch, Oncology, Diabetes, Medicine, Clinical Research, Pharmacovigilance, Clinical Development, Healthcare, Dermatology, Clinical Trials, Neurology, Organizational...
Education
University of Sao Paulo, FIA 2005 — 2006
EMBA, Business Administration
Federal University of Sao Paulo, EPM 1984 — 1992
MD, Pediatrics
Loura Coons Loura Coons's Shire HGT Experience September 2012 - August 2013
Job Full Stack Developer at Ariett Business Solutions
Industry Biotechnology
Experience
Ariett August 2013 - Present
Shire HGT September 2012 - August 2013
Shire HGT July 2011 - September 2012
University of Massachusetts May 2007 - June 2010
Skills
C#, ASP.NET, AJAX, JavaScript, PHP, jQuery UI, jQuery, Concrete5, Oracle SQL Developer, Photoshop, Crystal Reports, LIMS, SharePoint, SharePoint Designer, Java, Databases, Agile Methodologies, SQL
Education
UMass Lowell 2007 — 2010
Master of Science (MS), Computational and Applied Mathematics
UMass Lowell 2003 — 2007
B.S. Mathematics, Minor Computer Science, Concentration Bioinformatics
Ariett August 2013 - Present
Shire HGT September 2012 - August 2013
Shire HGT July 2011 - September 2012
University of Massachusetts May 2007 - June 2010
Skills
C#, ASP.NET, AJAX, JavaScript, PHP, jQuery UI, jQuery, Concrete5, Oracle SQL Developer, Photoshop, Crystal Reports, LIMS, SharePoint, SharePoint Designer, Java, Databases, Agile Methodologies, SQL
Education
UMass Lowell 2007 — 2010
Master of Science (MS), Computational and Applied Mathematics
UMass Lowell 2003 — 2007
B.S. Mathematics, Minor Computer Science, Concentration Bioinformatics
Thomas Roper Thomas Roper's Shire HGT Experience 2012 - 2012
Job Bioprocess Engineer and Cell Culture Specialist at Biovolutions
Industry Biotechnology
Experience
Biovolutions April 2013 - Present
Derek Lovely's Geobacter Laboratory at University of Massachusetts Amherst October 2011 - May 2012
Shire HGT 2012 - 2012
Skills
Gel Electrophoresis, Protein Purification, SDS-PAGE, DNA extraction, PCR, real-time PCR, Transformations, Cell Culture, Enzyme Assays, Media Production, Western Blotting, Pipetting, Micropipetting, FDA GMP, Clean Room Environment, Bioreactor, Laminar Flow Hoods, ELISA, Absorption Spectroscopy, Honeywell DCS
Education
University of Massachusetts, Amherst 2008 — 2012
Bachelor of Science, Biochemistry and Molecular Biology
Westford Academy 2004 — 2008
Biovolutions April 2013 - Present
Derek Lovely's Geobacter Laboratory at University of Massachusetts Amherst October 2011 - May 2012
Shire HGT 2012 - 2012
Skills
Gel Electrophoresis, Protein Purification, SDS-PAGE, DNA extraction, PCR, real-time PCR, Transformations, Cell Culture, Enzyme Assays, Media Production, Western Blotting, Pipetting, Micropipetting, FDA GMP, Clean Room Environment, Bioreactor, Laminar Flow Hoods, ELISA, Absorption Spectroscopy, Honeywell DCS
Education
University of Massachusetts, Amherst 2008 — 2012
Bachelor of Science, Biochemistry and Molecular Biology
Westford Academy 2004 — 2008
Rebecca Andrews Matthews Rebecca Andrews Matthews's Shire HGT Experience December 2009 - Present
Job Senior Administrative Assistant at Shire HGT
Industry Pharmaceuticals
Experience
Shire HGT December 2009 - Present
Skills
Product Launch, Training, Medical Devices, Sales, Management, CRM, Pharmaceutical Sales, Managed Care, Endocrinology, Marketing, Pharmaceutical Industry, Sales Operations, Biotechnology, Oncology, Sales Effectiveness, Account Management, Budgets, Urology, Leadership, Cross-functional Team..., Event Planning, Events Coordination, Meeting Planning, Organizing Meetings, Scheduling, Legal Compliance, Sarbanes-Oxley Act, Concur, Access
Education
Worcester State University 1997 — 2003
Bachelors Business Administration, Concentration Management
University of Massachusetts, Amherst 1993 — 1994
Undergrad
Shire HGT December 2009 - Present
Skills
Product Launch, Training, Medical Devices, Sales, Management, CRM, Pharmaceutical Sales, Managed Care, Endocrinology, Marketing, Pharmaceutical Industry, Sales Operations, Biotechnology, Oncology, Sales Effectiveness, Account Management, Budgets, Urology, Leadership, Cross-functional Team..., Event Planning, Events Coordination, Meeting Planning, Organizing Meetings, Scheduling, Legal Compliance, Sarbanes-Oxley Act, Concur, Access
Education
Worcester State University 1997 — 2003
Bachelors Business Administration, Concentration Management
University of Massachusetts, Amherst 1993 — 1994
Undergrad
Melissa Finn Melissa Finn's Shire HGT Experience 2010 - 2011
Job
Industry Biotechnology
Experience
Shire HGT 2010 - 2011
Shire Pharmaceuticals 2010 - 2011
Trankskaryotic Therapies (TKT) 1995 - 2005
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Windows, Research, Immunohistochemistry, Immunostaining, Histology, Slide Preparation, in vivo drug discovery, Pathology, Tissue Culture, Bioreactor, Image analysis
Education
University of New Hampshire 1991 — 1995
Bachelor of Science (B.S.), Biology, General
Shire HGT 2010 - 2011
Shire Pharmaceuticals 2010 - 2011
Trankskaryotic Therapies (TKT) 1995 - 2005
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Windows, Research, Immunohistochemistry, Immunostaining, Histology, Slide Preparation, in vivo drug discovery, Pathology, Tissue Culture, Bioreactor, Image analysis
Education
University of New Hampshire 1991 — 1995
Bachelor of Science (B.S.), Biology, General
Kelly Levasseur Kelly Levasseur's Shire HGT Experience April 2012 - December 2012
Job Quality Control/Quality Assurance
Industry Biotechnology
Experience
ACT July 2014 - June 2015
ACT March 2014 - July 2014
Integrated DNA Technologies November 2013 - January 2014
Shire HGT April 2012 - December 2012
Biogen Idec February 2008 - December 2011
Biogen Idec June 2004 - February 2008
UAB May 1985 - April 2004
Skills
Cancer, Proteomics, Protein Chemistry, Quality Control, Quality Assurance, Quality System, Biotechnology, Biopharmaceuticals, GMP, Biochemistry, Project Management, Metrics, Continuous Improvement, Change Control, Technical Writing, Editing, Stability, Regulatory Submissions, FDA/ICH guidelines, Track/Trend Data, SOP..., Data tables/Data..., Gap Analysis, Expiry, LIMS, Deviations/OOS/OOT, Trackwise, HPLC, Chromatography, Protein/Peptide..., Amino Acid/Hexosamine..., Assay Development, GLP, Contract labs, CMOs/CROs, HTML/Web design, ELISA, SDS-PAGE, Purification, Protein Purification, Immunoassays, MS Office (Excel, Word,..., Adobe Professional, JMP, SigmaPlot, Photoshop, Visio, Lotus Notes, eDocs, R&D
Education
University of Alabama at Birmingham
ACT July 2014 - June 2015
ACT March 2014 - July 2014
Integrated DNA Technologies November 2013 - January 2014
Shire HGT April 2012 - December 2012
Biogen Idec February 2008 - December 2011
Biogen Idec June 2004 - February 2008
UAB May 1985 - April 2004
Skills
Cancer, Proteomics, Protein Chemistry, Quality Control, Quality Assurance, Quality System, Biotechnology, Biopharmaceuticals, GMP, Biochemistry, Project Management, Metrics, Continuous Improvement, Change Control, Technical Writing, Editing, Stability, Regulatory Submissions, FDA/ICH guidelines, Track/Trend Data, SOP..., Data tables/Data..., Gap Analysis, Expiry, LIMS, Deviations/OOS/OOT, Trackwise, HPLC, Chromatography, Protein/Peptide..., Amino Acid/Hexosamine..., Assay Development, GLP, Contract labs, CMOs/CROs, HTML/Web design, ELISA, SDS-PAGE, Purification, Protein Purification, Immunoassays, MS Office (Excel, Word,..., Adobe Professional, JMP, SigmaPlot, Photoshop, Visio, Lotus Notes, eDocs, R&D
Education
University of Alabama at Birmingham
Christine Gakuya Christine Gakuya's Shire HGT Experience July 2012 - Present
Job Quality Assurance Specialist at Infinity Pharmaceuticals
Industry Pharmaceuticals
Experience
Infinity Pharmaceuticals August 2013 - Present
Shire HGT July 2012 - Present
Johnson Matthey Pharma Services October 2010 - July 2012
American Training February 2007 - January 2009
Legal Consultants for Immigration August 2006 - February 2007
Skills
Proficient in MS Office, Experience with..., Experience with CisPro, Documentation, cGMP, Quality Assurance, Biotechnology, Life Sciences, Trackwise, GMP
Education
UMass Lowell 2006 — 2010
Biotechnology, Biology with Biotechnology Concentration
Infinity Pharmaceuticals August 2013 - Present
Shire HGT July 2012 - Present
Johnson Matthey Pharma Services October 2010 - July 2012
American Training February 2007 - January 2009
Legal Consultants for Immigration August 2006 - February 2007
Skills
Proficient in MS Office, Experience with..., Experience with CisPro, Documentation, cGMP, Quality Assurance, Biotechnology, Life Sciences, Trackwise, GMP
Education
UMass Lowell 2006 — 2010
Biotechnology, Biology with Biotechnology Concentration
Mark Baglin's Shire HGT Experience May 2009 - June 2011
Job Vice President, Product Strategy Team Leader at Shire Pharmaceuticals
Industry Biotechnology
Experience
Shire Pharmaceuticals November 2013 - Present
Shire Pharmaceuticals Rare Disease Business Unit (Formerly Shire HGT) January 2011 - November 2013
Shire HGT May 2009 - June 2011
Endo Pharmaceuticals October 2006 - April 2008
Ethicon April 2004 - October 2006
Johnson & Johnson April 2002 - April 2004
Johnson & Johnson March 2000 - April 2002
AstraZeneca Pharmaceuticals February 1999 - April 2000
Zeneca February 1996 - March 1999
Zeneca May 1993 - October 1996
Skills
Oncology, Global Marketing, Cross-functional Team..., Pharmaceutical Sales, Pharmaceutical Industry, Product Launch, Sales Effectiveness, Strategy, Leadership, Hospital Sales, Marketing Strategy, Product Development, Biotechnology, Medical Devices, Sales Operations, Product Marketing, Business Development, Business Planning, Start-ups
Education
The University of Birmingham 1981 — 1984
Bachelor of Commerce (B.Com.), Business/Commerce, General
King Edward VI Camp Hill 1971 — 1983
Shire Pharmaceuticals November 2013 - Present
Shire Pharmaceuticals Rare Disease Business Unit (Formerly Shire HGT) January 2011 - November 2013
Shire HGT May 2009 - June 2011
Endo Pharmaceuticals October 2006 - April 2008
Ethicon April 2004 - October 2006
Johnson & Johnson April 2002 - April 2004
Johnson & Johnson March 2000 - April 2002
AstraZeneca Pharmaceuticals February 1999 - April 2000
Zeneca February 1996 - March 1999
Zeneca May 1993 - October 1996
Skills
Oncology, Global Marketing, Cross-functional Team..., Pharmaceutical Sales, Pharmaceutical Industry, Product Launch, Sales Effectiveness, Strategy, Leadership, Hospital Sales, Marketing Strategy, Product Development, Biotechnology, Medical Devices, Sales Operations, Product Marketing, Business Development, Business Planning, Start-ups
Education
The University of Birmingham 1981 — 1984
Bachelor of Commerce (B.Com.), Business/Commerce, General
King Edward VI Camp Hill 1971 — 1983
Lisa Morelli Lisa Morelli's Shire HGT Experience August 2009 - May 2010
Job Late Phase Research Manager at HealthCore, Inc.
Industry Biotechnology
Experience
HealthCore, Inc. April 2012 - Present
Clinical Resource Solutions, LLC January 2009 - Present
Atrium Medical Corporation September 2010 - March 2012
Shire HGT August 2009 - May 2010
Sirtris Pharmaceuticals, Inc (a GSK company) January 2007 - October 2008
Certus International January 2004 - December 2006
Transkaryotic Therapies, Inc. (now Shire Pharmaceuticals) November 2001 - December 2003
Diatide Research Labs/Berlex Laboratories, Inc. (now Bayer) January 1998 - November 2001
Skills
Clinical Trials, GCP, Clinical Monitoring, Clinical Development, CTMS, EDC, Drug Development, Clinical Research, Biotechnology, Oncology, CRO, Clinical Data Management, Data Management, Lifesciences, Medical Devices, Life Sciences
Education
University of New Hampshire-Manchester
HealthCore, Inc. April 2012 - Present
Clinical Resource Solutions, LLC January 2009 - Present
Atrium Medical Corporation September 2010 - March 2012
Shire HGT August 2009 - May 2010
Sirtris Pharmaceuticals, Inc (a GSK company) January 2007 - October 2008
Certus International January 2004 - December 2006
Transkaryotic Therapies, Inc. (now Shire Pharmaceuticals) November 2001 - December 2003
Diatide Research Labs/Berlex Laboratories, Inc. (now Bayer) January 1998 - November 2001
Skills
Clinical Trials, GCP, Clinical Monitoring, Clinical Development, CTMS, EDC, Drug Development, Clinical Research, Biotechnology, Oncology, CRO, Clinical Data Management, Data Management, Lifesciences, Medical Devices, Life Sciences
Education
University of New Hampshire-Manchester
Gary Palefsky's Shire HGT Experience January 2009 - Present
Job Security Director
Industry Security and Investigations
Experience
Shire HGT January 2009 - Present
GAP Ventures 2007 - December 2008
EMC Corporation 1998 - 2006
Stratus Computer 1986 - 1998
New Balance Athletic Shoe, Inc 1981 - 1986
XXIII Summer Olympic Games 1984 - 1984
Skills
Contingency Planning, Teamwork, Result Oriented, Fiscally Responsible, Risk Management, Security Operations, Customer Service, Security Management, Business Continuity, Risk Assessment, Operations Management, Security, Private Investigations, Program Management, Access Control
Education
State University of New York At Buffalo 1974 — 1978
BA
Municipal Police Training Academy
Diploma
New York State Division of Criminal Justice Services
Certification
Shire HGT January 2009 - Present
GAP Ventures 2007 - December 2008
EMC Corporation 1998 - 2006
Stratus Computer 1986 - 1998
New Balance Athletic Shoe, Inc 1981 - 1986
XXIII Summer Olympic Games 1984 - 1984
Skills
Contingency Planning, Teamwork, Result Oriented, Fiscally Responsible, Risk Management, Security Operations, Customer Service, Security Management, Business Continuity, Risk Assessment, Operations Management, Security, Private Investigations, Program Management, Access Control
Education
State University of New York At Buffalo 1974 — 1978
BA
Municipal Police Training Academy
Diploma
New York State Division of Criminal Justice Services
Certification
Sweta Walia's Shire HGT Experience December 2012 - Present
Job Quality Assurance, Manager QC Support at Shire HGT
Industry Biotechnology
Experience
Shire HGT December 2012 - Present
Skills
GMP, Biotechnology, HPLC, cGMP, Data Analysis, Auditing, Laboratory Oversight, CAPA, Change Management, Project Management, Regulatory Filings, Annual Reports, SOP, FDA
Education
Tufts University
Master of Science (M.S.), Biotechnology
University of Illinois at Chicago
Bachelor's degree, Biology, General
Shire HGT December 2012 - Present
Skills
GMP, Biotechnology, HPLC, cGMP, Data Analysis, Auditing, Laboratory Oversight, CAPA, Change Management, Project Management, Regulatory Filings, Annual Reports, SOP, FDA
Education
Tufts University
Master of Science (M.S.), Biotechnology
University of Illinois at Chicago
Bachelor's degree, Biology, General
Hemant Patel's Shire HGT Experience December 2010 - October 2012
Job
Industry Pharmaceuticals
Experience
Boston Biomedical August 2015 - Present
ImmunoGen, Inc. October 2012 - August 2015
Shire HGT December 2010 - October 2012
AMAG Pharmaceuticals May 2009 - December 2010
Wyeth Research July 2004 - May 2009
Harvard Medical School November 1999 - July 2004
MIT November 1999 - July 2004
University of Oxford October 1997 - November 1999
Skills
Biotechnology, Drug Development, Clinical Research, Clinical Trials, Oncology, Outstanding..., Team Building, Leadership
Education
Southampton University
Doctor of Philosophy (Ph.D.), Brain Tumours
University of Strathclyde 1986 — 1988
Master of Science (MSc), Pharmacology
University of Liverpool 1983 — 1986
BSc, Pharmacology
Boston Biomedical August 2015 - Present
ImmunoGen, Inc. October 2012 - August 2015
Shire HGT December 2010 - October 2012
AMAG Pharmaceuticals May 2009 - December 2010
Wyeth Research July 2004 - May 2009
Harvard Medical School November 1999 - July 2004
MIT November 1999 - July 2004
University of Oxford October 1997 - November 1999
Skills
Biotechnology, Drug Development, Clinical Research, Clinical Trials, Oncology, Outstanding..., Team Building, Leadership
Education
Southampton University
Doctor of Philosophy (Ph.D.), Brain Tumours
University of Strathclyde 1986 — 1988
Master of Science (MSc), Pharmacology
University of Liverpool 1983 — 1986
BSc, Pharmacology
Nijad Kifayeh's Shire HGT Experience August 2010 - September 2011
Job Clinical Research Professional
Industry Pharmaceuticals
Experience
Beitak co. June 2013 - January 2015
CORRONA, Inc. February 2012 - May 2013
Shire HGT August 2010 - September 2011
Shire HGT August 2009 - August 2010
PAREXEL International Corporation February 2008 - May 2009
PAREXEL International Corporation June 2007 - February 2008
Baystate Clinical Research January 2005 - November 2005
Sentient Medical Systems September 2002 - October 2004
The University of Massachusetts September 2001 - May 2002
Skills
Clinical Trial..., Clinical Research, GCP, Clinical Trials, Clinical, ICH-GCP, Clinical Development, Regulatory Affairs
Education
The University of Sydney, School of Public Health 2005 — 2006
Masters of Science, International Public Health; Health Projects Management; Applied Biostatistics
University of Massachusetts, Amherst 1998 — 2002
Bachelors of Science, Biology; Neuroscience
Beitak co. June 2013 - January 2015
CORRONA, Inc. February 2012 - May 2013
Shire HGT August 2010 - September 2011
Shire HGT August 2009 - August 2010
PAREXEL International Corporation February 2008 - May 2009
PAREXEL International Corporation June 2007 - February 2008
Baystate Clinical Research January 2005 - November 2005
Sentient Medical Systems September 2002 - October 2004
The University of Massachusetts September 2001 - May 2002
Skills
Clinical Trial..., Clinical Research, GCP, Clinical Trials, Clinical, ICH-GCP, Clinical Development, Regulatory Affairs
Education
The University of Sydney, School of Public Health 2005 — 2006
Masters of Science, International Public Health; Health Projects Management; Applied Biostatistics
University of Massachusetts, Amherst 1998 — 2002
Bachelors of Science, Biology; Neuroscience
Douglas Ducharme's Shire HGT Experience 2007 - Present
Job Senior Lead Investigator at Shire Pharmaceuticals
Industry Biotechnology
Experience
Shire Pharmaceuticals April 2015 - Present
Shire February 2007 - Present
Shire HGT 2007 - Present
RenaMed Biologics 2005 - 2006
Skills
Aseptic Processing, GMP, Trackwise, Biotechnology, Sop, Biopharmaceuticals, CAPA, Validation, Technology Transfer, Change Control, Aseptic Technique, FDA, 21 CFR Part 11, LIMS, Filtration, Deviations, Quality System, Cell Culture, Cleaning Validation, GLP, SOP
Education
University of Massachusetts Dartmouth 2000 — 2002
University of Massachusetts Dartmouth
Bachelor's degree
Shire Pharmaceuticals April 2015 - Present
Shire February 2007 - Present
Shire HGT 2007 - Present
RenaMed Biologics 2005 - 2006
Skills
Aseptic Processing, GMP, Trackwise, Biotechnology, Sop, Biopharmaceuticals, CAPA, Validation, Technology Transfer, Change Control, Aseptic Technique, FDA, 21 CFR Part 11, LIMS, Filtration, Deviations, Quality System, Cell Culture, Cleaning Validation, GLP, SOP
Education
University of Massachusetts Dartmouth 2000 — 2002
University of Massachusetts Dartmouth
Bachelor's degree
Melissa Roulleau's Shire HGT Experience October 2009 - Present
Job Director, Production Technical Services at Shire Pharmaceuticals
Industry Biotechnology
Experience
Shire Pharmaceuticals January 2014 - Present
Shire HGT October 2009 - Present
Shire Pharmaceuticals 2007 - Present
GSK Biologicals Inc. 2005 - 2006
Shire Biologics 2000 - 2006
Organogenesis Inc. 1996 - 2000
Biopure Corporation 1994 - 1996
Education
University of Cincinnati 1988 — 1993
Shire Pharmaceuticals January 2014 - Present
Shire HGT October 2009 - Present
Shire Pharmaceuticals 2007 - Present
GSK Biologicals Inc. 2005 - 2006
Shire Biologics 2000 - 2006
Organogenesis Inc. 1996 - 2000
Biopure Corporation 1994 - 1996
Education
University of Cincinnati 1988 — 1993
Beelin Cheang's Shire HGT Experience February 2013 - January 2015
Job Associate Director, Integrated Development Team Lead at BristolMyers Squibb
Industry Biotechnology
Experience
Bristol-Myers Squibb January 2015 - Present
Shire HGT February 2013 - January 2015
Shire Human Genetic Therapies September 2009 - January 2013
GTC Biotherapeutics February 2007 - August 2009
Talecris Biotherapeutics 2004 - 2007
Genentech, Inc. 2001 - 2002
Education
University of Delaware 2000 — 2004
PhD, Chemical Engineering
University at Buffalo 1996 — 1998
BS, Chemical Engineering
Bristol-Myers Squibb January 2015 - Present
Shire HGT February 2013 - January 2015
Shire Human Genetic Therapies September 2009 - January 2013
GTC Biotherapeutics February 2007 - August 2009
Talecris Biotherapeutics 2004 - 2007
Genentech, Inc. 2001 - 2002
Education
University of Delaware 2000 — 2004
PhD, Chemical Engineering
University at Buffalo 1996 — 1998
BS, Chemical Engineering
Jenn Lambert's Shire HGT Experience April 2008 - July 2012
Job Program Manager at Genzyme, a Sanofi company
Industry Biotechnology
Experience
Genzyme, a Sanofi company March 2013 - Present
Genzyme July 2012 - March 2013
Shire HGT April 2008 - July 2012
Lonza Biologics November 2005 - September 2007
Lonza Biologics April 2004 - November 2005
Lonza Biologics October 2003 - April 2004
Lonza Biologics March 2003 - October 2003
Lonza Biologics March 2002 - March 2003
GlaxoSmithKline March 2001 - March 2002
GlaxoSmithKline November 1998 - March 2001
Skills
CAPA, GMP, Sop, Validation, 21 CFR Part 11, LIMS, Deviations, FDA, Biotechnology, Biopharmaceuticals, Quality System, Technology Transfer, Cleaning Validation, Quality Assurance, Change Control, Quality Control, HPLC, Chromatography
Education
University of Rhode Island 1992 — 1998
Bachelor of Science, Bachelor of Arts, Chemical Engineering, German
Genzyme, a Sanofi company March 2013 - Present
Genzyme July 2012 - March 2013
Shire HGT April 2008 - July 2012
Lonza Biologics November 2005 - September 2007
Lonza Biologics April 2004 - November 2005
Lonza Biologics October 2003 - April 2004
Lonza Biologics March 2003 - October 2003
Lonza Biologics March 2002 - March 2003
GlaxoSmithKline March 2001 - March 2002
GlaxoSmithKline November 1998 - March 2001
Skills
CAPA, GMP, Sop, Validation, 21 CFR Part 11, LIMS, Deviations, FDA, Biotechnology, Biopharmaceuticals, Quality System, Technology Transfer, Cleaning Validation, Quality Assurance, Change Control, Quality Control, HPLC, Chromatography
Education
University of Rhode Island 1992 — 1998
Bachelor of Science, Bachelor of Arts, Chemical Engineering, German
Mark DeRose's Shire HGT Experience September 2006 - December 2014
Job at
Industry Pharmaceuticals
Experience
Sarepta Therapeutics December 2014 - Present
Shire HGT September 2006 - December 2014
Biodel, Inc August 2005 - September 2006
Education
University of Maryland University College 2011 — 2013
MBA
University of Connecticut 1997 — 2002
BS in Chemistry, BA in English
Sarepta Therapeutics December 2014 - Present
Shire HGT September 2006 - December 2014
Biodel, Inc August 2005 - September 2006
Education
University of Maryland University College 2011 — 2013
MBA
University of Connecticut 1997 — 2002
BS in Chemistry, BA in English
Julie Vickers's Shire HGT Experience January 2008 - August 2010
Job Principal Process Engineering Consultant at Pharmatech Process Services, LLC
Industry Biotechnology
Experience
The Hart Companies July 2015 - Present
Genzyme, a Sanofi company September 2011 - July 2015
Hart Design Group August 2010 - September 2011
Shire HGT January 2008 - August 2010
Amgen, Inc August 2005 - November 2007
Engineered Technologies Corporation October 2001 - August 2005
Arch Chemicals August 1993 - October 2001
Skills
Process Engineering, Biotechnology, Cell Culture, Fermentation, Aseptic Processing, Technology Transfer, Purification, Chromatography, TFF, Filtration, CAPA, Change Management, Commissioning, Project Management, Trackwise, Change Control, Protein Purification, Downstream Processing, Ultrafiltration, Capital Projects, 21 CFR Part 11, Continuous Improvement, Engineering, FDA, GMP, Manufacturing, Pharmaceutical Industry, Validation
Education
University of Rhode Island
Bachelor of Science, Chemical Engineering
The Hart Companies July 2015 - Present
Genzyme, a Sanofi company September 2011 - July 2015
Hart Design Group August 2010 - September 2011
Shire HGT January 2008 - August 2010
Amgen, Inc August 2005 - November 2007
Engineered Technologies Corporation October 2001 - August 2005
Arch Chemicals August 1993 - October 2001
Skills
Process Engineering, Biotechnology, Cell Culture, Fermentation, Aseptic Processing, Technology Transfer, Purification, Chromatography, TFF, Filtration, CAPA, Change Management, Commissioning, Project Management, Trackwise, Change Control, Protein Purification, Downstream Processing, Ultrafiltration, Capital Projects, 21 CFR Part 11, Continuous Improvement, Engineering, FDA, GMP, Manufacturing, Pharmaceutical Industry, Validation
Education
University of Rhode Island
Bachelor of Science, Chemical Engineering
Ravi Samavedam's Shire HGT Experience December 2008 - June 2012
Job General Manager at Azzur Group
Industry Biotechnology
Experience
Azzur Group May 2014 - Present
BioSPEQ July 2012 - Present
Shire HGT December 2008 - June 2012
Amgen August 2003 - December 2008
Baxter BioScience August 2000 - June 2003
Skills
Process Validation, cGMP, Disposables, Cleaning Validation, CMC, Biotech Manufacturing, Aseptic Processing, Technology Transfer, Regulatory Submissions, Extractables and..., Cold Chain..., Validation Maintenance, Validation, V&V, Biotechnology, GMP, Quality Control, Biopharmaceuticals, 21 CFR Part 11, Change Control, FDA, Computer System..., CAPA, Pharmaceutics, Sop, Pharmaceutical Industry, LIMS, SOP
Education
University of Minnesota-Twin Cities 1997 — 2000
HBTI, Kanpur 1993 — 1997
B. Tech, Biochemical Engineering
BJB College 1990 — 1993
Azzur Group May 2014 - Present
BioSPEQ July 2012 - Present
Shire HGT December 2008 - June 2012
Amgen August 2003 - December 2008
Baxter BioScience August 2000 - June 2003
Skills
Process Validation, cGMP, Disposables, Cleaning Validation, CMC, Biotech Manufacturing, Aseptic Processing, Technology Transfer, Regulatory Submissions, Extractables and..., Cold Chain..., Validation Maintenance, Validation, V&V, Biotechnology, GMP, Quality Control, Biopharmaceuticals, 21 CFR Part 11, Change Control, FDA, Computer System..., CAPA, Pharmaceutics, Sop, Pharmaceutical Industry, LIMS, SOP
Education
University of Minnesota-Twin Cities 1997 — 2000
HBTI, Kanpur 1993 — 1997
B. Tech, Biochemical Engineering
BJB College 1990 — 1993
Peter Ferguson's Shire HGT Experience December 2012 - Present
Job Engineer at Shire HGT
Industry Biotechnology
Experience
Shire HGT December 2012 - Present
Genzyme January 2011 - December 2012
Bristol-Myers Squibb 2007 - January 2011
Wyeth Biotech 2003 - 2007
Monsanto 2001 - 2003
Education
University of Massachusetts, Amherst
Shire HGT December 2012 - Present
Genzyme January 2011 - December 2012
Bristol-Myers Squibb 2007 - January 2011
Wyeth Biotech 2003 - 2007
Monsanto 2001 - 2003
Education
University of Massachusetts, Amherst
Heather Valley, RAC's Shire HGT Experience August 2009 - March 2010
Job Prin RA Specialist Medtronic
Industry Medical Devices
Experience
Medtronic April 2015 - Present
Atrium Medical/Maquet Getinge Group September 2013 - April 2015
Philips Healthcare April 2011 - September 2013
Pleiad Inc March 2010 - December 2010
McCormick LifeScience Consultants, LLC 2009 - April 2010
Shire HGT August 2009 - March 2010
Vertex Pharmaceuticals February 2008 - December 2008
Rapid Micro Biosystems 2003 - 2007
Millipore 2001 - 2003
Skills
FDA, Regulatory Affairs, Biotechnology, Lifesciences, Medical Devices, Regulatory Submissions, Pharmaceutical Industry, GMP, GLP, Clinical Trials, CAPA, Validation, ISO 13485, Microbiology, Biopharmaceuticals, Quality Assurance, Quality System, 21 CFR Part 11, Clinical Development, R&D, V&V, Design Control, Change Control
Education
University of Massachusetts Lowell 2005 — 2008
Masters Degree, Clinical Laboratory Sciences
University of Massachusetts Lowell 2003 — 2005
Clinical Pathology Certificate, Pathology
University of Massachusetts, Amherst 1996 — 2001
Bachelors Degree, Microbiology
Medtronic April 2015 - Present
Atrium Medical/Maquet Getinge Group September 2013 - April 2015
Philips Healthcare April 2011 - September 2013
Pleiad Inc March 2010 - December 2010
McCormick LifeScience Consultants, LLC 2009 - April 2010
Shire HGT August 2009 - March 2010
Vertex Pharmaceuticals February 2008 - December 2008
Rapid Micro Biosystems 2003 - 2007
Millipore 2001 - 2003
Skills
FDA, Regulatory Affairs, Biotechnology, Lifesciences, Medical Devices, Regulatory Submissions, Pharmaceutical Industry, GMP, GLP, Clinical Trials, CAPA, Validation, ISO 13485, Microbiology, Biopharmaceuticals, Quality Assurance, Quality System, 21 CFR Part 11, Clinical Development, R&D, V&V, Design Control, Change Control
Education
University of Massachusetts Lowell 2005 — 2008
Masters Degree, Clinical Laboratory Sciences
University of Massachusetts Lowell 2003 — 2005
Clinical Pathology Certificate, Pathology
University of Massachusetts, Amherst 1996 — 2001
Bachelors Degree, Microbiology
Tatiana Ishida's Shire HGT Experience January 2010 - February 2011
Job Director, Emerging Markets Regulatory Affairs at Takeda Pharmaceuticals
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals October 2015 - Present
Takeda Farmacêutica Brasil October 2014 - September 2015
Takeda September 2011 - October 2014
Nycomed March 2011 - October 2011
Shire HGT January 2010 - February 2011
Shire HGT July 2008 - July 2010
Shire HGT November 2007 - September 2008
Bristol-Myers Squibb March 2006 - November 2007
Janssen-Cilag 1999 - 2006
Skills
Pharmaceutical Industry, Regulatory Affairs, GMP, Biotechnology, Pharmacovigilance, Regulatory Submissions, Oncology, Sop, Quality Assurance, Validation, Clinical Trials, FDA, Regulatory Requirements, GCP, Drug Development, Biopharmaceuticals, Pharmaceutical Sales, Clinical Development, IND, Market Access, eCTD, Technology Transfer, CMC, 21 CFR Part 11, Pharmaceutics, CRO, Therapeutic Areas, Medical Affairs, GxP
Education
FIA - Fundação Instituto de Administração 2011 — 2014
MBA
Universidade Presbiteriana Mackenzie 2003 — 2008
Law
Universidade de São Paulo 1997 — 2002
PharmD
Takeda Pharmaceuticals October 2015 - Present
Takeda Farmacêutica Brasil October 2014 - September 2015
Takeda September 2011 - October 2014
Nycomed March 2011 - October 2011
Shire HGT January 2010 - February 2011
Shire HGT July 2008 - July 2010
Shire HGT November 2007 - September 2008
Bristol-Myers Squibb March 2006 - November 2007
Janssen-Cilag 1999 - 2006
Skills
Pharmaceutical Industry, Regulatory Affairs, GMP, Biotechnology, Pharmacovigilance, Regulatory Submissions, Oncology, Sop, Quality Assurance, Validation, Clinical Trials, FDA, Regulatory Requirements, GCP, Drug Development, Biopharmaceuticals, Pharmaceutical Sales, Clinical Development, IND, Market Access, eCTD, Technology Transfer, CMC, 21 CFR Part 11, Pharmaceutics, CRO, Therapeutic Areas, Medical Affairs, GxP
Education
FIA - Fundação Instituto de Administração 2011 — 2014
MBA
Universidade Presbiteriana Mackenzie 2003 — 2008
Law
Universidade de São Paulo 1997 — 2002
PharmD
Dave Perrotta's Shire HGT Experience July 2009 - December 2013
Job Senior Process Engineer at Process Design Solutions
Industry Biotechnology
Experience
Process Design Solutions July 2009 - Present
Shire HGT July 2009 - December 2013
NNE Pharmaplan October 2007 - July 2009
Wyeth Biotech September 2006 - September 2007
Wyeth BioPharma 2001 - 2006
Skills
FDA, GMP, Fermentation, Technology Transfer, Biopharmaceuticals, Validation, Filtration, CAPA, Aseptic Processing, Biotechnology, V&V, Purification, Cell Culture, Change Control, Chromatography, Sop, Downstream Processing, Pharmaceutical Industry
Education
Tufts University 2004 — 2008
ME, Biotechnology Engineering
University of Massachusetts, Amherst 1997 — 2001
BS, Microbiology
Process Design Solutions July 2009 - Present
Shire HGT July 2009 - December 2013
NNE Pharmaplan October 2007 - July 2009
Wyeth Biotech September 2006 - September 2007
Wyeth BioPharma 2001 - 2006
Skills
FDA, GMP, Fermentation, Technology Transfer, Biopharmaceuticals, Validation, Filtration, CAPA, Aseptic Processing, Biotechnology, V&V, Purification, Cell Culture, Change Control, Chromatography, Sop, Downstream Processing, Pharmaceutical Industry
Education
Tufts University 2004 — 2008
ME, Biotechnology Engineering
University of Massachusetts, Amherst 1997 — 2001
BS, Microbiology
Jen Bukoff's Shire HGT Experience August 2011 - July 2013
Job Manager, QC Operations at Shire HGT
Industry Biotechnology
Experience
Shire HGT August 2011 - July 2013
Shire HGT August 2010 - October 2011
Shire HGT July 2007 - January 2011
Avant Immunotherapeutics, Inc. 2004 - 2007
Skills
Biopharmaceuticals, Biotechnology, CAPA, Change Control, FDA, GMP, Microbiology, Pharmaceutical Industry, Quality Control, SOP, Validation, LIMS, Quality System
Education
University of Florida 1996 — 1999
Shire HGT August 2011 - July 2013
Shire HGT August 2010 - October 2011
Shire HGT July 2007 - January 2011
Avant Immunotherapeutics, Inc. 2004 - 2007
Skills
Biopharmaceuticals, Biotechnology, CAPA, Change Control, FDA, GMP, Microbiology, Pharmaceutical Industry, Quality Control, SOP, Validation, LIMS, Quality System
Education
University of Florida 1996 — 1999
Jeff Bernier's Shire HGT Experience Clinical Project ManagerTherion Biologics2003 - 2005
Job Sr Manager, Clinical Programs at Shire HGT
Industry Biotechnology
Experience
Shire HGT Clinical Project ManagerTherion Biologics2003 - 2005
Education
University of Connecticut 1989 — 1993
Shire HGT Clinical Project ManagerTherion Biologics2003 - 2005
Education
University of Connecticut 1989 — 1993
Natacha Miller's Shire HGT Experience March 2013 - Present
Job Associate Director RA at Shire Pharmaceuticals
Industry Pharmaceuticals
Experience
Shire Pharmaceuticals January 2015 - Present
Shire HGT March 2013 - Present
AMGEN (formerly BioVex Inc) February 2011 - March 2013
Genzyme September 2007 - February 2011
The Cadmus Group August 2006 - September 2007
Wold Food Program (WFP) July 2005 - December 2005
Ministry of the Environment and Natural Resources - Dominican Republic August 2000 - September 2001
Skills
Biotechnology, Regulatory Affairs, Biopharmaceuticals, Pharmaceutical Industry, Regulatory Submissions, 21 CFR Part 11, Clinical Development, FDA, IND, Regulatory Requirements, Medical Devices, Clinical Trials, GMP
Education
Tufts University 1998 — 2000
M.S., Civil and Environmental Engineering
Shire Pharmaceuticals January 2015 - Present
Shire HGT March 2013 - Present
AMGEN (formerly BioVex Inc) February 2011 - March 2013
Genzyme September 2007 - February 2011
The Cadmus Group August 2006 - September 2007
Wold Food Program (WFP) July 2005 - December 2005
Ministry of the Environment and Natural Resources - Dominican Republic August 2000 - September 2001
Skills
Biotechnology, Regulatory Affairs, Biopharmaceuticals, Pharmaceutical Industry, Regulatory Submissions, 21 CFR Part 11, Clinical Development, FDA, IND, Regulatory Requirements, Medical Devices, Clinical Trials, GMP
Education
Tufts University 1998 — 2000
M.S., Civil and Environmental Engineering
Linda Schocken's Shire HGT Experience July 2009 - July 2013
Job Quality Assurance/Training Consultant
Industry Pharmaceuticals
Experience
Schocken Consulting July 2013 - Present
Shire HGT July 2009 - July 2013
MannKind Corporation March 2005 - June 2009
Purdue Pharma 2001 - 2005
Oread, Inc., April 1998 - June 2000
Oread, Inc January 1997 - April 1998
Springborn Laboratories, Inc., March 1992 - January 1997
Springborn Laboratories, Inc. June 1989 - March 1992
Skills
21 CFR Part 11, Sop, GMP, CAPA, FDA, Validation, Pharmaceutical Industry, Computer System..., Change Control, Quality System, GxP, GLP, Biotechnology, Quality Assurance, Regulatory Submissions, GCP, Medical Devices, Biopharmaceuticals, Quality Auditing, HPLC, Regulatory Requirements, Analytical Chemistry, Clinical Trials, CRO, Clinical Development, ISO
Education
University of Massachusetts Boston 2007 — 2016
MEd, Instructional Design
The University of Connecticut 2000 — 2006
Bachelor's degree, Health & Science
Schocken Consulting July 2013 - Present
Shire HGT July 2009 - July 2013
MannKind Corporation March 2005 - June 2009
Purdue Pharma 2001 - 2005
Oread, Inc., April 1998 - June 2000
Oread, Inc January 1997 - April 1998
Springborn Laboratories, Inc., March 1992 - January 1997
Springborn Laboratories, Inc. June 1989 - March 1992
Skills
21 CFR Part 11, Sop, GMP, CAPA, FDA, Validation, Pharmaceutical Industry, Computer System..., Change Control, Quality System, GxP, GLP, Biotechnology, Quality Assurance, Regulatory Submissions, GCP, Medical Devices, Biopharmaceuticals, Quality Auditing, HPLC, Regulatory Requirements, Analytical Chemistry, Clinical Trials, CRO, Clinical Development, ISO
Education
University of Massachusetts Boston 2007 — 2016
MEd, Instructional Design
The University of Connecticut 2000 — 2006
Bachelor's degree, Health & Science
Zina M. Johnson's Shire HGT Experience December 2011 - November 2012
Job Associate Director, Medical Science at ThromboGenics
Industry Biotechnology
Experience
ThromboGenics May 2014 - Present
ThromboGenics November 2012 - May 2014
Shire HGT December 2011 - November 2012
Inspire Pharmaceuticals August 2008 - July 2011
CellzDirect Inc./Invitrogen Corp. August 2007 - August 2008
UIC Dept of Biophysics and Physiology January 2001 - August 2003
US Air Force August 1994 - August 1998
Skills
Pharmaceuticals, Cell Biology, Infectious Diseases, Ophthalmology, Biotechnology, Clinical Development, Pharmaceutical Industry, Molecular Biology, Clinical Trials, Lifesciences, Biopharmaceuticals, Immunology, Clinical Research, CTMS, Medicine, Drug Development, Oncology, Medical Affairs, Medical Writing, Neurology, CRO, FDA, Pharmacology, Drug Discovery, Vaccines, Therapeutic Areas, GCP, In Vitro, Biochemistry
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2007 — 2008
Launch the Venture Program
University of North Carolina at Chapel Hill School of Medicine 2003 — 2007
PhD, Cell Biology
University of Illinois at Chicago 1998 — 2001
B.S., Biological Sciences
ThromboGenics May 2014 - Present
ThromboGenics November 2012 - May 2014
Shire HGT December 2011 - November 2012
Inspire Pharmaceuticals August 2008 - July 2011
CellzDirect Inc./Invitrogen Corp. August 2007 - August 2008
UIC Dept of Biophysics and Physiology January 2001 - August 2003
US Air Force August 1994 - August 1998
Skills
Pharmaceuticals, Cell Biology, Infectious Diseases, Ophthalmology, Biotechnology, Clinical Development, Pharmaceutical Industry, Molecular Biology, Clinical Trials, Lifesciences, Biopharmaceuticals, Immunology, Clinical Research, CTMS, Medicine, Drug Development, Oncology, Medical Affairs, Medical Writing, Neurology, CRO, FDA, Pharmacology, Drug Discovery, Vaccines, Therapeutic Areas, GCP, In Vitro, Biochemistry
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2007 — 2008
Launch the Venture Program
University of North Carolina at Chapel Hill School of Medicine 2003 — 2007
PhD, Cell Biology
University of Illinois at Chicago 1998 — 2001
B.S., Biological Sciences
Bhairav Parekh's Shire HGT Experience May 2009 - February 2013
Job Global Biosimilars Regulatory Affairs, Senior Manager at Amgen
Industry Biotechnology
Experience
Amgen March 2015 - Present
Amgen February 2013 - February 2015
Shire HGT May 2009 - February 2013
USC Norris Cancer Center January 2009 - May 2009
Indian Institute of Technology, Bombay January 2008 - March 2008
SRM University July 2006 - December 2006
Skills
CMC Regulatory Affairs, Regulatory Affairs, Biotechnology, Regulatory Submissions, CMC, FDA, Biopharmaceuticals, Technology Transfer, IND, Clinical Trials, Regulatory Requirements, Drug Development
Education
University of Southern California 2008 — 2010
MS, Regulatory Science
SRM University 2004 — 2008
Bachelor of Technology, Biotechnology
Amgen March 2015 - Present
Amgen February 2013 - February 2015
Shire HGT May 2009 - February 2013
USC Norris Cancer Center January 2009 - May 2009
Indian Institute of Technology, Bombay January 2008 - March 2008
SRM University July 2006 - December 2006
Skills
CMC Regulatory Affairs, Regulatory Affairs, Biotechnology, Regulatory Submissions, CMC, FDA, Biopharmaceuticals, Technology Transfer, IND, Clinical Trials, Regulatory Requirements, Drug Development
Education
University of Southern California 2008 — 2010
MS, Regulatory Science
SRM University 2004 — 2008
Bachelor of Technology, Biotechnology
Charan Leng's Shire HGT Experience June 2006 - September 2012
Job Sr. Research Associate at FORMA Therapeutics, Inc.
Industry Biotechnology
Experience
FORMA Therapeutics, Inc. July 2014 - Present
Ember Therapeutics April 2014 - June 2014
Vertex Pharmaceuticals December 2012 - November 2013
Shire HGT June 2006 - September 2012
Hologic (previously Cytyc) May 2003 - June 2006
VARIAGENICS INC 2001 - 2003
EMD Millipore 1999 - 2001
Cereon Genomics 1997 - 1999
Skills
ELISA, Mass Spectrometry, Cell Signaling, FACS analysis, Western Blotting, high throughput imaging, Proliferation, stable and transient..., RNAi, High Content Screening, RT-PCR and qRT-PCR, Functional assay..., DNA and RNA isolation..., AlphaScreen, Cell Sorting, Biomarker Discovery, Expression Cloning, Fluorescence and..., Cellular targeting and..., LC-MS/MS, ADME characterization, Differentiation, Assay automation
Education
University of Massachusetts, Amherst 1992 — 1997
BS, Microbiology
FORMA Therapeutics, Inc. July 2014 - Present
Ember Therapeutics April 2014 - June 2014
Vertex Pharmaceuticals December 2012 - November 2013
Shire HGT June 2006 - September 2012
Hologic (previously Cytyc) May 2003 - June 2006
VARIAGENICS INC 2001 - 2003
EMD Millipore 1999 - 2001
Cereon Genomics 1997 - 1999
Skills
ELISA, Mass Spectrometry, Cell Signaling, FACS analysis, Western Blotting, high throughput imaging, Proliferation, stable and transient..., RNAi, High Content Screening, RT-PCR and qRT-PCR, Functional assay..., DNA and RNA isolation..., AlphaScreen, Cell Sorting, Biomarker Discovery, Expression Cloning, Fluorescence and..., Cellular targeting and..., LC-MS/MS, ADME characterization, Differentiation, Assay automation
Education
University of Massachusetts, Amherst 1992 — 1997
BS, Microbiology
David Goyette's Shire HGT Experience April 2008 - February 2011
Job Experienced Manufacturing Technician
Industry Biotechnology
Experience
Genzyme June 2013 - Present
Genzyme April 2011 - June 2013
Shire HGT April 2008 - February 2011
MassBioLogics 2003 - 2008
Skills
Aseptic Technique, CAPA, Biotechnology, GMP, Chromatography, Purification, Validation, SOP, FDA, Biopharmaceuticals
Education
University of Massachusetts Dartmouth 2001 — 2003
Biology, Biology
Genzyme June 2013 - Present
Genzyme April 2011 - June 2013
Shire HGT April 2008 - February 2011
MassBioLogics 2003 - 2008
Skills
Aseptic Technique, CAPA, Biotechnology, GMP, Chromatography, Purification, Validation, SOP, FDA, Biopharmaceuticals
Education
University of Massachusetts Dartmouth 2001 — 2003
Biology, Biology
Lynette Cook Anderson's Shire HGT Experience 1998 - 2010
Job Sr. Research Scientist at BristolMyers Squibb
Industry Biotechnology
Experience
Bristol-Myers Squibb September 2014 - Present
121 Bio November 2013 - September 2014
AVEO Pharmaceuticals June 2010 - October 2013
Shire HGT 1998 - 2010
Skills
ELISA, Protein Chemistry, Biochemistry, Purification, SDS-PAGE, Assay Development, In Vitro, Protein Purification, AKTA, Size Exclusion, Affinity Purification, Ion Exchange, Molecular Biology, Western Blotting, Chromatography, HPLC, Liquid Chromatography, Ion Chromatography, Affinity Chromatography, Mass Spectrometry, Mammalian Cell Culture, Bacterial Culture, Primary Cells, Media Development, Stable Transfection, Transient Transfection, Bioreactor, Flow Cytometry, Cell Sorting, Cell Based Assay, Confocal Microscopy, Epitope Mapping, Immunofluorescence, Immunocytochemistry, Enzyme Assays, Enzyme Kinetics, Glycosylation, RNA isolation, mRNA Delivery, siRNA, DNA electrophoresis, DNA ligation, recombinant DNA..., Plasmid Isolation, Cell Culture, Biotechnology
Education
University of New Hampshire 1994 — 1998
BS, Biology
UMass Lowell 2005 — 2008
Graduate, Biological Sciences
Bristol-Myers Squibb September 2014 - Present
121 Bio November 2013 - September 2014
AVEO Pharmaceuticals June 2010 - October 2013
Shire HGT 1998 - 2010
Skills
ELISA, Protein Chemistry, Biochemistry, Purification, SDS-PAGE, Assay Development, In Vitro, Protein Purification, AKTA, Size Exclusion, Affinity Purification, Ion Exchange, Molecular Biology, Western Blotting, Chromatography, HPLC, Liquid Chromatography, Ion Chromatography, Affinity Chromatography, Mass Spectrometry, Mammalian Cell Culture, Bacterial Culture, Primary Cells, Media Development, Stable Transfection, Transient Transfection, Bioreactor, Flow Cytometry, Cell Sorting, Cell Based Assay, Confocal Microscopy, Epitope Mapping, Immunofluorescence, Immunocytochemistry, Enzyme Assays, Enzyme Kinetics, Glycosylation, RNA isolation, mRNA Delivery, siRNA, DNA electrophoresis, DNA ligation, recombinant DNA..., Plasmid Isolation, Cell Culture, Biotechnology
Education
University of New Hampshire 1994 — 1998
BS, Biology
UMass Lowell 2005 — 2008
Graduate, Biological Sciences
Julio Quintana's Shire HGT Experience January 2012 - April 2012
Job Manager at PwC
Industry Information Technology and Services
Experience
PwC September 2014 - Present
Ernst & Young March 2013 - September 2014
Clarkston Consulting, Inc. June 2007 - March 2013
Auxilium Pharmaceuticals 2013 - 2013
SSM Health Care October 2012 - December 2012
Shire HGT January 2012 - April 2012
Bacardi USA August 2011 - January 2012
Human Genome Sciences February 2011 - August 2011
Church & Dwight, Co., Inc. January 2011 - February 2011
United Therapeutics December 2010 - January 2011
Skills
Revenue Recognition, FI/CO, SAP, Process Improvement, SAP R/3, Projects, ERP, SAP ERP, SAP Implementation, Testing
Education
University of Florida - Warrington College Of Business 1976 — 1981
BSBA, Finance
PwC September 2014 - Present
Ernst & Young March 2013 - September 2014
Clarkston Consulting, Inc. June 2007 - March 2013
Auxilium Pharmaceuticals 2013 - 2013
SSM Health Care October 2012 - December 2012
Shire HGT January 2012 - April 2012
Bacardi USA August 2011 - January 2012
Human Genome Sciences February 2011 - August 2011
Church & Dwight, Co., Inc. January 2011 - February 2011
United Therapeutics December 2010 - January 2011
Skills
Revenue Recognition, FI/CO, SAP, Process Improvement, SAP R/3, Projects, ERP, SAP ERP, SAP Implementation, Testing
Education
University of Florida - Warrington College Of Business 1976 — 1981
BSBA, Finance
Chris Landreville's Shire HGT Experience March 2004 - Present
Job Senior Controls Engineer at Shire HGT
Industry Biotechnology
Experience
Shire HGT March 2004 - Present
Wyeth BioPharma 2001 - 2004
CDM 1998 - 2001
Skills
Control Logic, GAMP, Allen Bradley, Instrumentation, Automation, PLC, Process Control, SCADA, Validation, iFix, MES, DeviceNet, ControlNet, Process Simulation, GMP, FDA, Calibration, Change Control, TWS, Robotics, Foundation Fieldbus, DCS, Process Automation, Wonderware, Commissioning, CAPA, Control Systems Design, WebDAV, 21 CFR Part 11, Computer System..., Profibus, HMIs, Industrial Control, V&V, Modbus, Variable Frequency..., Motion Control, PLC Programming, ControlLogix, OSIsoft PI
Education
University of Massachusetts Dartmouth 1994 — 1997
BS, Electrical Engineering
Shire HGT March 2004 - Present
Wyeth BioPharma 2001 - 2004
CDM 1998 - 2001
Skills
Control Logic, GAMP, Allen Bradley, Instrumentation, Automation, PLC, Process Control, SCADA, Validation, iFix, MES, DeviceNet, ControlNet, Process Simulation, GMP, FDA, Calibration, Change Control, TWS, Robotics, Foundation Fieldbus, DCS, Process Automation, Wonderware, Commissioning, CAPA, Control Systems Design, WebDAV, 21 CFR Part 11, Computer System..., Profibus, HMIs, Industrial Control, V&V, Modbus, Variable Frequency..., Motion Control, PLC Programming, ControlLogix, OSIsoft PI
Education
University of Massachusetts Dartmouth 1994 — 1997
BS, Electrical Engineering
Gary Battiato's Shire HGT Experience April 2010 - April 2013
Job Setup and Support Specialist at LogCheck
Industry Facilities Services
Experience
LogCheck February 2015 - Present
Shire Pharmaceuticals / contractor July 2014 - February 2015
Genzyme April 2013 - July 2014
Shire HGT April 2010 - April 2013
Biotest Pharmaceuticals Corporation February 2009 - April 2010
Suspended Animation January 2006 - February 2009
CRB Consulting Engineers July 2004 - January 2006
Lonza September 1999 - July 2004
Skills
Sop, Software Documentation, GMP, Manufacturing, Commissioning, Validation, Bill of Materials, Materials, Product Design, Quality System, Technical Writing, Quality Assurance, Aseptic Processing, SOP, Biotechnology
Education
University of New Hampshire 1995 — 1999
BS, Environmental science
University of New Hampshire
Bachelor of Science (B.S.)
LogCheck February 2015 - Present
Shire Pharmaceuticals / contractor July 2014 - February 2015
Genzyme April 2013 - July 2014
Shire HGT April 2010 - April 2013
Biotest Pharmaceuticals Corporation February 2009 - April 2010
Suspended Animation January 2006 - February 2009
CRB Consulting Engineers July 2004 - January 2006
Lonza September 1999 - July 2004
Skills
Sop, Software Documentation, GMP, Manufacturing, Commissioning, Validation, Bill of Materials, Materials, Product Design, Quality System, Technical Writing, Quality Assurance, Aseptic Processing, SOP, Biotechnology
Education
University of New Hampshire 1995 — 1999
BS, Environmental science
University of New Hampshire
Bachelor of Science (B.S.)
Lora Cameron-Landis's Shire HGT Experience October 2012 - October 2013
Job Senior Process Engineer/Project Manager at Pall Life Sciences
Industry Pharmaceuticals
Experience
Pall Life Sciences February 2015 - Present
Hyde Engineering + Consulting November 2013 - Present
Shire HGT October 2012 - October 2013
Joule Unlimited, Inc. April 2011 - October 2012
Pfizer August 2005 - April 2011
University of Massachusetts Amherst August 2004 - June 2005
STERIS Corporation May 2003 - August 2004
Akron Polymer Laboratories 2001 - 2003
Skills
SDS-PAGE, Transfection, Protein Purification, Cell Culture, ELISA, Protein Chemistry, Genetics, Tissue Culture, Cell, Protein Expression, In Vitro, Microbiology, PCR, Biotechnology, Immunology, Cell Biology, GLP, Drug Discovery, Flow Cytometry, Technology Transfer, Biochemistry, High Throughput..., In Vivo, Chromatography, Aseptic Technique, Cancer, Lifesciences, Assay Development, HPLC, Antibodies, Laboratory, Western Blotting, Purification, Mass Spectrometry, Monoclonal Antibodies, GMP, Biopharmaceuticals, Molecular Biology, Proteomics, Fermentation, Gel Electrophoresis, Vaccines, Downstream Processing, Validation, Bioprocessing, Filtration, Sop, Analytical Chemistry, Microscopy, LIMS
Education
Tufts University 2005 — 2007
Chemical Engineering
University of Massachusetts, Amherst 2004 — 2005
Microbiology
Wilkes University 1998 — 2000
B.Sc., Biology, Chemistry
Pall Life Sciences February 2015 - Present
Hyde Engineering + Consulting November 2013 - Present
Shire HGT October 2012 - October 2013
Joule Unlimited, Inc. April 2011 - October 2012
Pfizer August 2005 - April 2011
University of Massachusetts Amherst August 2004 - June 2005
STERIS Corporation May 2003 - August 2004
Akron Polymer Laboratories 2001 - 2003
Skills
SDS-PAGE, Transfection, Protein Purification, Cell Culture, ELISA, Protein Chemistry, Genetics, Tissue Culture, Cell, Protein Expression, In Vitro, Microbiology, PCR, Biotechnology, Immunology, Cell Biology, GLP, Drug Discovery, Flow Cytometry, Technology Transfer, Biochemistry, High Throughput..., In Vivo, Chromatography, Aseptic Technique, Cancer, Lifesciences, Assay Development, HPLC, Antibodies, Laboratory, Western Blotting, Purification, Mass Spectrometry, Monoclonal Antibodies, GMP, Biopharmaceuticals, Molecular Biology, Proteomics, Fermentation, Gel Electrophoresis, Vaccines, Downstream Processing, Validation, Bioprocessing, Filtration, Sop, Analytical Chemistry, Microscopy, LIMS
Education
Tufts University 2005 — 2007
Chemical Engineering
University of Massachusetts, Amherst 2004 — 2005
Microbiology
Wilkes University 1998 — 2000
B.Sc., Biology, Chemistry
Mary Taylor's Shire HGT Experience August 2011 - November 2012
Job Consultant at Independant
Industry Pharmaceuticals
Experience
Independant October 2015 - Present
Civitas Therapeutics/Acorda May 2013 - May 2015
Shire HGT August 2011 - November 2012
Lantheus Medical Imaging January 2009 - August 2011
Tolerx January 2008 - December 2008
CuraGen Corporation 2003 - 2008
Bayer Pharmaceuticals 2001 - 2003
Parke-Davis 1982 - 2001
Warner Lambert 1982 - 2001
Skills
Drug Development, IND, Clinical Development, Regulatory Affairs, Biotechnology, Regulatory Submissions, Biopharmaceuticals, Infectious Diseases, Pharmaceutical Industry, Clinical Trials, Lifesciences, GCP, Clinical Research, CRO, FDA, Oncology, Sop, CTMS, Pharmacovigilance, Immunology, Cancer, Drug Discovery, 21 CFR Part 11, Validation, GLP, Medical Writing, Regulatory Requirements, GMP, Vaccines, Biologics, Medical Affairs, GxP, Technology Transfer, Pharmacology, NDA, CAPA, Therapeutic Areas, Pharmaceutics, Life Sciences
Education
University of Michigan 1993 — 1995
MPH, Biochemistry
Independant October 2015 - Present
Civitas Therapeutics/Acorda May 2013 - May 2015
Shire HGT August 2011 - November 2012
Lantheus Medical Imaging January 2009 - August 2011
Tolerx January 2008 - December 2008
CuraGen Corporation 2003 - 2008
Bayer Pharmaceuticals 2001 - 2003
Parke-Davis 1982 - 2001
Warner Lambert 1982 - 2001
Skills
Drug Development, IND, Clinical Development, Regulatory Affairs, Biotechnology, Regulatory Submissions, Biopharmaceuticals, Infectious Diseases, Pharmaceutical Industry, Clinical Trials, Lifesciences, GCP, Clinical Research, CRO, FDA, Oncology, Sop, CTMS, Pharmacovigilance, Immunology, Cancer, Drug Discovery, 21 CFR Part 11, Validation, GLP, Medical Writing, Regulatory Requirements, GMP, Vaccines, Biologics, Medical Affairs, GxP, Technology Transfer, Pharmacology, NDA, CAPA, Therapeutic Areas, Pharmaceutics, Life Sciences
Education
University of Michigan 1993 — 1995
MPH, Biochemistry
Joseph Sollecito's Shire HGT Experience January 2009 - Present
Job Facilities Manager at Shire HGT
Industry Pharmaceuticals
Experience
Shire HGT January 2009 - Present
Biopure May 1985 - November 2008
Education
Tufts University 1983 — 1985
M.S., Chemical Engineering
Tufts University 1977 — 1982
B.S., Chemical Engineering
Regis High School 1973 — 1977
Shire HGT January 2009 - Present
Biopure May 1985 - November 2008
Education
Tufts University 1983 — 1985
M.S., Chemical Engineering
Tufts University 1977 — 1982
B.S., Chemical Engineering
Regis High School 1973 — 1977
Anne Bond's Shire HGT Experience 2010 - 2011
Job Validation Manager/Contractor
Industry Biotechnology
Experience
PP Manufacturing Corp. January 2011 - Present
QSI January 2009 - Present
Shire HGT 2010 - 2011
NNE Pharmaplan 2006 - 2009
Biopure 2006 - 2006
BioMetics 1997 - 2004
Oravax, Inc. 1995 - 1997
Repligen Corporation 1991 - 1995
Applied BioTechnoogy 1988 - 1991
Collaborative Research, Inc. 1987 - 1988
Education
University of Massachusetts Lowell 1987 — 2000
MS, Biological Sciences
University of Massachusetts Lowell 1983 — 1987
BS, Biological Sciences
PP Manufacturing Corp. January 2011 - Present
QSI January 2009 - Present
Shire HGT 2010 - 2011
NNE Pharmaplan 2006 - 2009
Biopure 2006 - 2006
BioMetics 1997 - 2004
Oravax, Inc. 1995 - 1997
Repligen Corporation 1991 - 1995
Applied BioTechnoogy 1988 - 1991
Collaborative Research, Inc. 1987 - 1988
Education
University of Massachusetts Lowell 1987 — 2000
MS, Biological Sciences
University of Massachusetts Lowell 1983 — 1987
BS, Biological Sciences
John Wing's Shire HGT Experience January 2011 - June 2014
Job Biotech and Pharmaceutical Professional
Industry Research
Experience
Shire HGT January 2011 - June 2014
Boston College April 2007 - June 2010
Eyetech Pharmaceuticals 2002 - 2006
Skills
Molecular Biology, Biotechnology, Cell Biology, Cell Culture, Lifesciences, Assay Development, Biochemistry, Protein Chemistry, Pharmaceutical Industry, Drug Development, Drug Discovery, Immunology, Cell, Oncology, Life Sciences, Clinical Trials
Education
University of Massachusetts, Amherst 1996 — 2001
Doctor of Philosophy (Ph.D.), Cell/Cellular and Molecular Biology
University of Massachusetts, Amherst 1996 — 2000
Ph.D., Molecular and Cellular Biology
Shire HGT January 2011 - June 2014
Boston College April 2007 - June 2010
Eyetech Pharmaceuticals 2002 - 2006
Skills
Molecular Biology, Biotechnology, Cell Biology, Cell Culture, Lifesciences, Assay Development, Biochemistry, Protein Chemistry, Pharmaceutical Industry, Drug Development, Drug Discovery, Immunology, Cell, Oncology, Life Sciences, Clinical Trials
Education
University of Massachusetts, Amherst 1996 — 2001
Doctor of Philosophy (Ph.D.), Cell/Cellular and Molecular Biology
University of Massachusetts, Amherst 1996 — 2000
Ph.D., Molecular and Cellular Biology
Jeffrey Gaspardino's Shire HGT Experience April 2010 - August 2013
Job Supervisor at Shire Pharmaceuticals
Industry Biotechnology
Experience
Shire Pharmaceuticals August 2013 - Present
Shire HGT April 2010 - August 2013
Lonza February 2007 - April 2010
Skills
cGMP, Aseptic Technique, GMP, SOP, LIMS, Biotechnology, Filtration, Aseptic Processing, Ultrafiltration, Biopharmaceuticals, CAPA, CIP, Quality Systems, Chromatography, Purification, Column Chromatography, Process Development, Protein Purification, Operational Excellence, DeltaV, Spectrophotometry, Documentation, Manufacturing, Sop, Validation, FDA, Technology Transfer
Education
University of New Hampshire 1997 — 1999
Business
University of New Hampshire
Business
Shire Pharmaceuticals August 2013 - Present
Shire HGT April 2010 - August 2013
Lonza February 2007 - April 2010
Skills
cGMP, Aseptic Technique, GMP, SOP, LIMS, Biotechnology, Filtration, Aseptic Processing, Ultrafiltration, Biopharmaceuticals, CAPA, CIP, Quality Systems, Chromatography, Purification, Column Chromatography, Process Development, Protein Purification, Operational Excellence, DeltaV, Spectrophotometry, Documentation, Manufacturing, Sop, Validation, FDA, Technology Transfer
Education
University of New Hampshire 1997 — 1999
Business
University of New Hampshire
Business
Joyce Whitehead's Shire HGT Experience June 2012 - Present
Job Director, Manufacturing at Shire HGT
Industry Pharmaceuticals
Experience
Shire HGT June 2012 - Present
Shire HGT February 2009 - June 2012
Bristol-Myers Squibb January 2002 - February 2009
Bristol-Myers Squibb 2002 - 2009
Bristol Myers Squibb, Syracuse NY 2002 - 2009
Skills
Validation, Biopharmaceuticals, Pharmaceutical Industry, Technology Transfer, GMP
Education
University of Massachusetts, Amherst 1987 — 1993
PhD, Chemistry
Shire HGT June 2012 - Present
Shire HGT February 2009 - June 2012
Bristol-Myers Squibb January 2002 - February 2009
Bristol-Myers Squibb 2002 - 2009
Bristol Myers Squibb, Syracuse NY 2002 - 2009
Skills
Validation, Biopharmaceuticals, Pharmaceutical Industry, Technology Transfer, GMP
Education
University of Massachusetts, Amherst 1987 — 1993
PhD, Chemistry
Paulina Andzie-Quainoo's Shire HGT Experience September 2007 - Present
Job Quality Control Senior Analyst
Industry Biotechnology
Experience
Shire HGT September 2007 - Present
Shire HGT September 2007 - June 2012
Matritech Inc July 2001 - August 2007
Skills
Sop, LIMS, 21 CFR Part 11, GLP, Biopharmaceuticals, FDA, Bioassay, Western Blotting, ELISA, Analytical Method..., CAPA, GMP Investigation, GMP, JMP, Parallel Line Analysis..., Assay Development, Biotechnology, Immunoassays, SOP, V, Validation
Education
Northeastern University 2002 — 2004
MsC, Bioinformatics
University of Massachusetts Boston 1997 — 2001
BS, Biology/Biotechnology
Shire HGT September 2007 - Present
Shire HGT September 2007 - June 2012
Matritech Inc July 2001 - August 2007
Skills
Sop, LIMS, 21 CFR Part 11, GLP, Biopharmaceuticals, FDA, Bioassay, Western Blotting, ELISA, Analytical Method..., CAPA, GMP Investigation, GMP, JMP, Parallel Line Analysis..., Assay Development, Biotechnology, Immunoassays, SOP, V, Validation
Education
Northeastern University 2002 — 2004
MsC, Bioinformatics
University of Massachusetts Boston 1997 — 2001
BS, Biology/Biotechnology
Judy Burns's Shire HGT Experience August 2009 - May 2010
Job Consultant, Medical Sciences at Alexion Pharmaceuticals, Inc.
Industry Biotechnology
Experience
Alexion Pharmaceuticals, Inc. April 2014 - Present
Shire HGT August 2009 - May 2010
TransMolecular, Inc. January 2006 - April 2009
Genzyme Corporation 1992 - December 2006
Skills
Clinical Research, Clinical Trials, Clinical Development
Education
Tufts University
Alexion Pharmaceuticals, Inc. April 2014 - Present
Shire HGT August 2009 - May 2010
TransMolecular, Inc. January 2006 - April 2009
Genzyme Corporation 1992 - December 2006
Skills
Clinical Research, Clinical Trials, Clinical Development
Education
Tufts University
Diana Hoganson's Shire HGT Experience August 2010 - December 2013
Job Associate Director, Elaprase Upstream Lead, MS&T, at Shire
Industry Biotechnology
Experience
Shire January 2014 - Present
Shire HGT August 2010 - December 2013
Eli Lilly and Company 2004 - 2010
BioMedica 2002 - 2004
Selective Genetics, Inc. 1997 - 2002
University of North Carolina at Chapel Hill 1994 - 1997
Education
University of North Carolina at Chapel Hill School of Medicine 1994 — 1997
Post-Doctoral Fellow, Translational gene Therapy
University of South Carolina-Columbia
Ph.D., Molecular Pharmacology
University of Minnesota-Morris 1984 — 1988
BA, Chemistry
Shire January 2014 - Present
Shire HGT August 2010 - December 2013
Eli Lilly and Company 2004 - 2010
BioMedica 2002 - 2004
Selective Genetics, Inc. 1997 - 2002
University of North Carolina at Chapel Hill 1994 - 1997
Education
University of North Carolina at Chapel Hill School of Medicine 1994 — 1997
Post-Doctoral Fellow, Translational gene Therapy
University of South Carolina-Columbia
Ph.D., Molecular Pharmacology
University of Minnesota-Morris 1984 — 1988
BA, Chemistry
Steven Glyman's Shire HGT Experience July 2012 - Present
Job Senior Director ,Clinical Sciences, Research and Development at Shire
Industry Pharmaceuticals
Experience
Shire April 2013 - Present
Shire HGT July 2012 - Present
Biogen Idec March 2011 - June 2012
EMD Serono, Inc. March 2009 - March 2011
University of Nevada Reno 2007 - 2009
Nevada Neurological Consultants Ltd. July 1987 - June 2007
Skills
Neurology, Clinical Trials, Medical Affairs, Rare Diseases, Biotechnology, Clinical Research, Alzheimer's disease, Neuroscience, Science, Clinical Development, Drug Development, Immunology, Oncology, Medical Writing, Medicine, Life Sciences
Education
University of California, Los Angeles 1977 — 1981
MD, Medicine
Shire April 2013 - Present
Shire HGT July 2012 - Present
Biogen Idec March 2011 - June 2012
EMD Serono, Inc. March 2009 - March 2011
University of Nevada Reno 2007 - 2009
Nevada Neurological Consultants Ltd. July 1987 - June 2007
Skills
Neurology, Clinical Trials, Medical Affairs, Rare Diseases, Biotechnology, Clinical Research, Alzheimer's disease, Neuroscience, Science, Clinical Development, Drug Development, Immunology, Oncology, Medical Writing, Medicine, Life Sciences
Education
University of California, Los Angeles 1977 — 1981
MD, Medicine
Robert Crampton's Shire HGT Experience April 2010 - Present
Job Lead Metrology Technician at Shire HGT
Industry Biotechnology
Experience
Shire HGT April 2010 - Present
Wyeth Biotech February 2004 - April 2010
Genzyme November 2001 - February 2004
Lucent Technologies May 2000 - August 2001
Skills
Calibration, Computer Hardware, Software Installation, Validation, Manufacturing, FDA, SOP, GMP
Education
University of Massachusetts Lowell
Information Technology, IT
Shire HGT April 2010 - Present
Wyeth Biotech February 2004 - April 2010
Genzyme November 2001 - February 2004
Lucent Technologies May 2000 - August 2001
Skills
Calibration, Computer Hardware, Software Installation, Validation, Manufacturing, FDA, SOP, GMP
Education
University of Massachusetts Lowell
Information Technology, IT
Funke Abiola's Shire HGT Experience June 2010 - Present
Job Experienced Molecular Biologist, Seasoned Microbiologist and Biotechnology Purification Associate
Industry Pharmaceuticals
Experience
Shire HGT June 2010 - Present
The Children's Hospital of Philadelphia September 2009 - May 2010
University of Pennsylvania School of Medicine February 2009 - May 2010
Shire HGT June 2009 - August 2009
PFIZER NIGERIA October 2005 - December 2005
Education
University of Pennsylvania 2008 — 2010
Masters, BIOTECHNOLOGY
LAGOS STATE UNIVERSITY
Bachelor of Science, Microbiology
Shire HGT June 2010 - Present
The Children's Hospital of Philadelphia September 2009 - May 2010
University of Pennsylvania School of Medicine February 2009 - May 2010
Shire HGT June 2009 - August 2009
PFIZER NIGERIA October 2005 - December 2005
Education
University of Pennsylvania 2008 — 2010
Masters, BIOTECHNOLOGY
LAGOS STATE UNIVERSITY
Bachelor of Science, Microbiology
David Zullo's Shire HGT Experience 2008 - 2009
Job QA Associate Director, Blue Stream Labs
Industry Biotechnology
Experience
Blue Stream Laboratories October 2009 - Present
bluebird bio 2013 - 2014
bluebird bio 2013 - 2014
Blue Stream Laboratories 2009 - 2011
Shire HGT 2008 - 2009
Shire Pharmaceuticals 2008 - 2009
Shire HGT 2008 - 2009
BG Medicine 2005 - 2008
Genzme Tissue Repair 1994 - 1996
ImmunoGen, Inc. 1988 - 1994
Skills
Change Control, GMP, FDA, GLP, FDA GMP, Compliance, Computer System..., Quality Auditing, Training, Document Management, Deviation Management, Investigation
Education
University of Massachusetts, Amherst 1979 — 1983
Bachelor's degree, Biology, General
Blue Stream Laboratories October 2009 - Present
bluebird bio 2013 - 2014
bluebird bio 2013 - 2014
Blue Stream Laboratories 2009 - 2011
Shire HGT 2008 - 2009
Shire Pharmaceuticals 2008 - 2009
Shire HGT 2008 - 2009
BG Medicine 2005 - 2008
Genzme Tissue Repair 1994 - 1996
ImmunoGen, Inc. 1988 - 1994
Skills
Change Control, GMP, FDA, GLP, FDA GMP, Compliance, Computer System..., Quality Auditing, Training, Document Management, Deviation Management, Investigation
Education
University of Massachusetts, Amherst 1979 — 1983
Bachelor's degree, Biology, General
Gene Liau's Shire HGT Experience August 2010 - July 2011
Job SVP Precision Biosciences
Industry Biotechnology
Experience
Precision BioSciences, Inc. September 2015 - Present
Pfizer December 2014 - Present
Pfizer July 2011 - December 2014
Shire HGT August 2010 - July 2011
Novartis Institutes for Biomedical Research January 2008 - September 2010
Novartis Institutes for Biomedical Research 2004 - 2008
Novartis Institute for Biomedical Research 2002 - 2004
Genetic Therapy Inc., A Novartis Company January 1998 - January 2002
George Washington University 1995 - 2000
American Red Cross 1987 - 2000
Skills
Lifesciences, Drug Discovery, Cancer, Biotechnology, Clinical Trials, R&D, Genetics, Medicine, Protein Chemistry, Entrepreneurship, Translational Medicine, Pharmaceutical Industry, Clinical Development, Leadership, Cell Biology, Molecular Biology, Research, Cardiovascular Disease, Science, Clinical Research, Pharmacology, Drug Development, Program Management
Education
Vanderbilt University 1977 — 1982
PhD, Biochemistry
University of North Carolina at Chapel Hill
Bachelor of Science (BS), Biology/Biological Sciences, General
Precision BioSciences, Inc. September 2015 - Present
Pfizer December 2014 - Present
Pfizer July 2011 - December 2014
Shire HGT August 2010 - July 2011
Novartis Institutes for Biomedical Research January 2008 - September 2010
Novartis Institutes for Biomedical Research 2004 - 2008
Novartis Institute for Biomedical Research 2002 - 2004
Genetic Therapy Inc., A Novartis Company January 1998 - January 2002
George Washington University 1995 - 2000
American Red Cross 1987 - 2000
Skills
Lifesciences, Drug Discovery, Cancer, Biotechnology, Clinical Trials, R&D, Genetics, Medicine, Protein Chemistry, Entrepreneurship, Translational Medicine, Pharmaceutical Industry, Clinical Development, Leadership, Cell Biology, Molecular Biology, Research, Cardiovascular Disease, Science, Clinical Research, Pharmacology, Drug Development, Program Management
Education
Vanderbilt University 1977 — 1982
PhD, Biochemistry
University of North Carolina at Chapel Hill
Bachelor of Science (BS), Biology/Biological Sciences, General
Pooja Kothari's Shire HGT Experience October 2010 - May 2011
Job Quality Systems Associate
Industry Pharmaceuticals
Experience
Amgen Inc. September 2014 - Present
Genzyme sanofi October 2012 - December 2013
Pfizer December 2011 - October 2012
Biogen Idec July 2011 - November 2011
Shire HGT October 2010 - May 2011
University of Massachusetts Amherst September 2008 - May 2010
University of Massachusetts September 2007 - December 2007
Skills
Microsoft Excel, PowerPoint, Microsoft Word, Mac OS X, Manufacturing, 5S, Photography, Technical Writing, Six Sigma, Chromatography, Mammalian Cell Culture, Data Analysis, Aseptic Technique, Chemistry, GMP
Education
University of Massachusetts 2006 — 2010
Bachelor of Science (B.S.), Biology
University of Massachusetts, Amherst 2006 — 2010
Bachelor of Science, Biology
Andover High School 2005 — 2006
Salem High School 2002 — 2005
Amgen Inc. September 2014 - Present
Genzyme sanofi October 2012 - December 2013
Pfizer December 2011 - October 2012
Biogen Idec July 2011 - November 2011
Shire HGT October 2010 - May 2011
University of Massachusetts Amherst September 2008 - May 2010
University of Massachusetts September 2007 - December 2007
Skills
Microsoft Excel, PowerPoint, Microsoft Word, Mac OS X, Manufacturing, 5S, Photography, Technical Writing, Six Sigma, Chromatography, Mammalian Cell Culture, Data Analysis, Aseptic Technique, Chemistry, GMP
Education
University of Massachusetts 2006 — 2010
Bachelor of Science (B.S.), Biology
University of Massachusetts, Amherst 2006 — 2010
Bachelor of Science, Biology
Andover High School 2005 — 2006
Salem High School 2002 — 2005
Rachel Romanek's Shire HGT Experience August 2011 - Present
Job Senior Process Engineer at Shire HGT
Industry Biotechnology
Experience
Shire HGT August 2011 - Present
Zajac LLC October 2010 - September 2011
Parsons February 2007 - August 2010
Wyeth Biotech March 2004 - February 2007
Skills
GMP, Testing, Automation, Chemical Engineering, Manufacturing, Troubleshooting, Process Equipment, Validation, Process Engineering, Process Simulation, Process Control, Quality System, Process Optimization, Commissioning, Design of Experiments, Technology Transfer
Education
University of Massachusetts Lowell 1998 — 2003
BS, Chemical Engineering
Shire HGT August 2011 - Present
Zajac LLC October 2010 - September 2011
Parsons February 2007 - August 2010
Wyeth Biotech March 2004 - February 2007
Skills
GMP, Testing, Automation, Chemical Engineering, Manufacturing, Troubleshooting, Process Equipment, Validation, Process Engineering, Process Simulation, Process Control, Quality System, Process Optimization, Commissioning, Design of Experiments, Technology Transfer
Education
University of Massachusetts Lowell 1998 — 2003
BS, Chemical Engineering
John E. Gill IV's Shire HGT Experience 1996 - Present
Job Associate Director, Cell Line Generation Lead at Shire HGT
Industry Biotechnology
Experience
Shire HGT 1996 - Present
US Army 1992 - 1993
Skills
Drug Discovery, Cell, Clinical Development, GLP, Cell Culture, GMP, Technology Transfer, Protein Purification, Molecular Biology, Transfection, Biopharmaceuticals, Biotechnology, Purification, ELISA, Process Simulation, Clinical Trials
Education
University of New Hampshire
B.S., Microbilogy
US Army Defense Language Institute 1992 — 1993
Korean Language training
Shire HGT 1996 - Present
US Army 1992 - 1993
Skills
Drug Discovery, Cell, Clinical Development, GLP, Cell Culture, GMP, Technology Transfer, Protein Purification, Molecular Biology, Transfection, Biopharmaceuticals, Biotechnology, Purification, ELISA, Process Simulation, Clinical Trials
Education
University of New Hampshire
B.S., Microbilogy
US Army Defense Language Institute 1992 — 1993
Korean Language training
Jeff Bardsley's Shire HGT Experience June 2009 - August 2009
Job Business Analyst at Government Scientific Source
Industry Accounting
Experience
Government Scientific Source June 2010 - Present
Shire HGT June 2009 - August 2009
Morgan Stanley Smith Barney June 2008 - August 2008
Skills
Access, Financial Analysis, Budgets, Microsoft Office, Microsoft Excel, Program Management, Project Management, Government Contracting, Management, Procurement
Education
University of Richmond - Robins School of Business 2009 — 2010
MAcc, Financial Accounting
University of Richmond 2005 — 2009
BSBA, Accounting
Government Scientific Source June 2010 - Present
Shire HGT June 2009 - August 2009
Morgan Stanley Smith Barney June 2008 - August 2008
Skills
Access, Financial Analysis, Budgets, Microsoft Office, Microsoft Excel, Program Management, Project Management, Government Contracting, Management, Procurement
Education
University of Richmond - Robins School of Business 2009 — 2010
MAcc, Financial Accounting
University of Richmond 2005 — 2009
BSBA, Accounting
Brent Safford's Shire HGT Experience 2001 - 2013
Job cGMP Facility Manager at Memorial SloanKettering Cancer Center
Industry Biotechnology
Experience
Memorial Sloan-Kettering Cancer Center December 2013 - Present
Shire HGT 2001 - 2013
Shire HGT 2001 - 2013
Shire Human Genetic Therapies February 2009 - 2012
Shire Human Genetic Therapies July 2006 - February 2009
Transkaryotic Therapies, Inc February 2005 - July 2006
Transkaryotic Therapies, Inc February 2003 - February 2005
Transkaryotic Therapies, Inc July 2001 - February 2003
Taconic Biotechnology October 1999 - July 2001
Skills
cGMP, Excel, Word, PowerPoint, Cell Culture, Process Development, GMP, Biotechnology, Deviations, Change Control, CAPA, Trackwise, Technology Transfer, Validation, SOP development, Regulatory Requirements, Regulatory Submissions, ICH guidelines, 21 CFR, Quality Assurance, TrackWise
Education
University at Albany, SUNY 1997 — 1999
BS, Biology
State University of New York at Cobleskill 1995 — 1997
A.A.S, Biological Technology
Memorial Sloan-Kettering Cancer Center December 2013 - Present
Shire HGT 2001 - 2013
Shire HGT 2001 - 2013
Shire Human Genetic Therapies February 2009 - 2012
Shire Human Genetic Therapies July 2006 - February 2009
Transkaryotic Therapies, Inc February 2005 - July 2006
Transkaryotic Therapies, Inc February 2003 - February 2005
Transkaryotic Therapies, Inc July 2001 - February 2003
Taconic Biotechnology October 1999 - July 2001
Skills
cGMP, Excel, Word, PowerPoint, Cell Culture, Process Development, GMP, Biotechnology, Deviations, Change Control, CAPA, Trackwise, Technology Transfer, Validation, SOP development, Regulatory Requirements, Regulatory Submissions, ICH guidelines, 21 CFR, Quality Assurance, TrackWise
Education
University at Albany, SUNY 1997 — 1999
BS, Biology
State University of New York at Cobleskill 1995 — 1997
A.A.S, Biological Technology
Phil Conti's Shire HGT Experience April 2006 - February 2008
Job at Merrimack Pharmaceuticals
Industry Biotechnology
Experience
Merrimack Pharmaceuticals November 2009 - Present
Pervasis Therapeutics February 2008 - May 2009
Shire HGT April 2006 - February 2008
Organogenesis February 2004 - April 2006
Biomedical Research Models June 2002 - September 2003
Cambridge Healthtech Institute November 2000 - June 2002
Community Newspaper Company August 2000 - November 2000
Skills
Protein Purification, Biotechnology, Biopharmaceuticals, Manufacturing, Aseptic Technique, UF/DF, Chromatography, GMP, campaign coordination, Extrusion, TOC, CIP, SIP, Unicorn, document generation and..., Metrics, Batch Records, TFF, Column Chromatography, Aseptic Processing
Education
University of Massachusetts Lowell 1996 — 2000
BA, English
Merrimack Pharmaceuticals November 2009 - Present
Pervasis Therapeutics February 2008 - May 2009
Shire HGT April 2006 - February 2008
Organogenesis February 2004 - April 2006
Biomedical Research Models June 2002 - September 2003
Cambridge Healthtech Institute November 2000 - June 2002
Community Newspaper Company August 2000 - November 2000
Skills
Protein Purification, Biotechnology, Biopharmaceuticals, Manufacturing, Aseptic Technique, UF/DF, Chromatography, GMP, campaign coordination, Extrusion, TOC, CIP, SIP, Unicorn, document generation and..., Metrics, Batch Records, TFF, Column Chromatography, Aseptic Processing
Education
University of Massachusetts Lowell 1996 — 2000
BA, English
Sheryl Guerard's Shire HGT Experience 2010 - 2012
Job Quality Control Training Lead at Baxalta Pharamcueticals
Industry Pharmaceuticals
Experience
Baxter HealthCare April 2014 - Present
Baxalta Pharamcueticals March 2014 - Present
Alexion July 2012 - April 2014
Shire HGT 2010 - 2012
Bristol-Myers Squibb May 2008 - September 2010
Lonza April 2006 - May 2008
AMgen Inc July 1999 - October 2005
Skills
SDS-PAGE, ELISA, Compliance, Cell Biology, Excel, Word, Visio, Biacore, Validation, LIMS, GMP, Cell Based Assays, SOP, Quality System, Raw Materials, Trackwise, Fishbone, Root Cause Problem..., Deviation Management, GMP Investigations, Sop, FDA, Biotechnology, Analytical Chemistry, Aseptic Technique, Change Control
Education
University of Maine 1981 — 1985
BS, Microbiology
University of Maine at Orono 1981 — 1985
Bachelor's of Science , in Microbiology
Baxter HealthCare April 2014 - Present
Baxalta Pharamcueticals March 2014 - Present
Alexion July 2012 - April 2014
Shire HGT 2010 - 2012
Bristol-Myers Squibb May 2008 - September 2010
Lonza April 2006 - May 2008
AMgen Inc July 1999 - October 2005
Skills
SDS-PAGE, ELISA, Compliance, Cell Biology, Excel, Word, Visio, Biacore, Validation, LIMS, GMP, Cell Based Assays, SOP, Quality System, Raw Materials, Trackwise, Fishbone, Root Cause Problem..., Deviation Management, GMP Investigations, Sop, FDA, Biotechnology, Analytical Chemistry, Aseptic Technique, Change Control
Education
University of Maine 1981 — 1985
BS, Microbiology
University of Maine at Orono 1981 — 1985
Bachelor's of Science , in Microbiology
Maida Cohen's Shire HGT Experience September 2012 - Present
Job Case Manager at Shire HGT
Industry Pharmaceuticals
Experience
Shire HGT September 2012 - Present
Shire HGT March 2012 - September 2012
HealthBridge/Express Scripts May 2007 - November 2009
BLOOMINGDALE’S, Chestnut Hill, MA October 1990 - May 2007
MEDICAL REIMBURSEMENT CONSULTING, June 1989 - December 1991
PHYSICIANS AND SURGEONS ASSOCIATION of MASSACHUSETTS February 1986 - June 1989
New England Medical Center 1975 - 1986
Skills
Customer Service, Customer Relations, Documentation, Utilization Review, Quality Assurance, Excel, Access, Word, Software Documentation, Sales, Microsoft Excel, Hospitals, Healthcare, Microsoft Word, Biotechnology
Education
University of Connecticut
Shire HGT September 2012 - Present
Shire HGT March 2012 - September 2012
HealthBridge/Express Scripts May 2007 - November 2009
BLOOMINGDALE’S, Chestnut Hill, MA October 1990 - May 2007
MEDICAL REIMBURSEMENT CONSULTING, June 1989 - December 1991
PHYSICIANS AND SURGEONS ASSOCIATION of MASSACHUSETTS February 1986 - June 1989
New England Medical Center 1975 - 1986
Skills
Customer Service, Customer Relations, Documentation, Utilization Review, Quality Assurance, Excel, Access, Word, Software Documentation, Sales, Microsoft Excel, Hospitals, Healthcare, Microsoft Word, Biotechnology
Education
University of Connecticut
Rathi Kodihal's Shire HGT Experience October 2012 - September 2013
Job Development Specialist at Shire Pharmaceuticals
Industry Biotechnology
Experience
Shire Pharmaceuticals September 2013 - Present
Shire HGT October 2012 - September 2013
Lonza biologics October 2011 - September 2012
Skills
PCR, ELISA, Enzyme Assays, Agarose Gel..., HPLC, Protein Purification, Cell Culture, Southern Blot, Western Blotting, Microsoft Excel, DNA extraction, Transfection, Microsoft Office, SDS-PAGE, Molecular Biology
Education
UMass Lowell 2009 — 2011
MS, Biotechnology
Sterling Institute of Pharmacy 2005 — 2009
Bachelors in Pharmacy
Shire Pharmaceuticals September 2013 - Present
Shire HGT October 2012 - September 2013
Lonza biologics October 2011 - September 2012
Skills
PCR, ELISA, Enzyme Assays, Agarose Gel..., HPLC, Protein Purification, Cell Culture, Southern Blot, Western Blotting, Microsoft Excel, DNA extraction, Transfection, Microsoft Office, SDS-PAGE, Molecular Biology
Education
UMass Lowell 2009 — 2011
MS, Biotechnology
Sterling Institute of Pharmacy 2005 — 2009
Bachelors in Pharmacy
Jessica Hackett's Shire HGT Experience October 2010 - November 2012
Job Senior Manager at Vertex Pharmaceuticals
Industry Pharmaceuticals
Experience
Akebia Therapeutics March 2015 - Present
Vertex Pharmaceuticals November 2012 - Present
Vertex Pharmaceuticals February 2015 - March 2015
Shire HGT October 2010 - November 2012
Novartis May 2008 - January 2011
Genzyme September 2004 - May 2008
Dana-Farber Cancer Institute September 2002 - September 2004
University at Buffalo September 2000 - August 2002
Skills
Clinical Research, GCP, Clinical Trials, Clinical Development, CTMS
Education
University of Massachusetts, Amherst 2007 — 2010
MPH
University at Buffalo 1997 — 2001
BA, Psychology
Akebia Therapeutics March 2015 - Present
Vertex Pharmaceuticals November 2012 - Present
Vertex Pharmaceuticals February 2015 - March 2015
Shire HGT October 2010 - November 2012
Novartis May 2008 - January 2011
Genzyme September 2004 - May 2008
Dana-Farber Cancer Institute September 2002 - September 2004
University at Buffalo September 2000 - August 2002
Skills
Clinical Research, GCP, Clinical Trials, Clinical Development, CTMS
Education
University of Massachusetts, Amherst 2007 — 2010
MPH
University at Buffalo 1997 — 2001
BA, Psychology
Michelle Bofill's Shire HGT Experience May 2010 - June 2011
Job Principal Quality Assurance Engineer at Genzyme
Industry Pharmaceuticals
Experience
Genzyme July 2011 - Present
Shire HGT May 2010 - June 2011
GlaxoSmithKline Biologicals June 2008 - May 2010
Eli Lilly and Company February 2004 - May 2008
Cordis LLC April 2001 - February 2004
Interamerican University January 1999 - January 2001
Skills
Validation, GMP, Quality System, Change Control, CAPA, FDA, Regulatory Affairs
Education
Universidad de Puerto Rico 1999 — 2001
PhD, Marine Sciences
Universidad de Puerto Rico 1996 — 1999
Master's in Science, Biology
Universidad de Puerto Rico 1991 — 1996
Bachelor of Science, Biology
Genzyme July 2011 - Present
Shire HGT May 2010 - June 2011
GlaxoSmithKline Biologicals June 2008 - May 2010
Eli Lilly and Company February 2004 - May 2008
Cordis LLC April 2001 - February 2004
Interamerican University January 1999 - January 2001
Skills
Validation, GMP, Quality System, Change Control, CAPA, FDA, Regulatory Affairs
Education
Universidad de Puerto Rico 1999 — 2001
PhD, Marine Sciences
Universidad de Puerto Rico 1996 — 1999
Master's in Science, Biology
Universidad de Puerto Rico 1991 — 1996
Bachelor of Science, Biology
Diane Piper's Shire HGT Experience February 2012 - May 2014
Job Director Clinical Standards at Shire Pharmaceuticals
Industry Biotechnology
Experience
Shire Pharmaceuticals May 2014 - Present
Shire HGT February 2012 - May 2014
Shire HGT February 2009 - February 2012
Shire HGT January 2007 - February 2009
TKT May 2002 - January 2007
PAREXEL August 1999 - May 2002
Wyeth Vaccines July 1998 - August 1999
PAREXEL November 1996 - July 1998
Lederle Laboratories November 1989 - October 1996
Skills
Clinical Data Management, Statistics, CDISC, Clinical Trials, EDC, Clinical Development, CRO, Pharmaceutical Industry, Biotechnology, Clinical Research, Oncology, Lifesciences, Clinical Study Design, Biostatistics, GCP, Drug Development, CTMS
Education
University of Southampton 1987 — 1989
M.Sc., Statistics with applications in Medicine
University of Portsmouth 1984 — 1987
B.Sc., Mathematical Sciences
Shire Pharmaceuticals May 2014 - Present
Shire HGT February 2012 - May 2014
Shire HGT February 2009 - February 2012
Shire HGT January 2007 - February 2009
TKT May 2002 - January 2007
PAREXEL August 1999 - May 2002
Wyeth Vaccines July 1998 - August 1999
PAREXEL November 1996 - July 1998
Lederle Laboratories November 1989 - October 1996
Skills
Clinical Data Management, Statistics, CDISC, Clinical Trials, EDC, Clinical Development, CRO, Pharmaceutical Industry, Biotechnology, Clinical Research, Oncology, Lifesciences, Clinical Study Design, Biostatistics, GCP, Drug Development, CTMS
Education
University of Southampton 1987 — 1989
M.Sc., Statistics with applications in Medicine
University of Portsmouth 1984 — 1987
B.Sc., Mathematical Sciences
Elise McCarthy's Shire HGT Experience September 2010 - Present
Job Senior QA Specialist at Shire
Industry Biotechnology
Experience
Shire Pharmaceuticals March 2014 - Present
Shire HGT September 2010 - Present
Associates of Cape Cod September 2008 - August 2010
Skills
Quality System, GMP, Biotechnology, CAPA, Quality Assurance, Validation, LIMS, Trackwise, Deviations, cGMP practices, cGMP manufacturing, SOP development, Change Control, Batch Records, Contract Manufacturing, 21 CFR Part 11, TrackWise, FDA, Biopharmaceuticals, SOP, Pharmaceutical Industry
Education
University of Massachusetts, Amherst 2004 — 2008
Bachelor of Science, Biology
Shire Pharmaceuticals March 2014 - Present
Shire HGT September 2010 - Present
Associates of Cape Cod September 2008 - August 2010
Skills
Quality System, GMP, Biotechnology, CAPA, Quality Assurance, Validation, LIMS, Trackwise, Deviations, cGMP practices, cGMP manufacturing, SOP development, Change Control, Batch Records, Contract Manufacturing, 21 CFR Part 11, TrackWise, FDA, Biopharmaceuticals, SOP, Pharmaceutical Industry
Education
University of Massachusetts, Amherst 2004 — 2008
Bachelor of Science, Biology
Anne-Renee (Graham) Fitzgerald's Shire HGT Experience
Job Senior Research Specialist I at Shire HGT
Industry Biotechnology
Experience
Shire HGT
Education
University of Florida 2002 — 2005
MS, Veterinary Medicine
University of Massachusetts, Amherst 1998 — 2002
BS, Animal Science
Shire HGT
Education
University of Florida 2002 — 2005
MS, Veterinary Medicine
University of Massachusetts, Amherst 1998 — 2002
BS, Animal Science
Sean DeLauter's Shire HGT Experience January 2008 - Present
Job National Account Director at Shire HGT
Industry Biotechnology
Experience
Shire HGT January 2008 - Present
Shire HGT January 2006 - January 2008
berlex oncology 2003 - 2006
Skills
Pharmaceutical Sales, Oncology, Market Access, Hematology, Biotechnology, Managed Care, Buy, Biopharmaceuticals, KOL development, Gastroenterology, Cardiology, Urology, Orthopedic, Nephrology, Hospital Sales, Rheumatology, Product Launch, Neurology, Dermatology, Pulmonology, Infectious Diseases, Endocrinology, Real Estate Transactions, Pharmaceutical Industry, Sales Effectiveness
Education
University of Missouri-Saint Louis 1992 — 1996
BS, Political science, Biology
Shire HGT January 2008 - Present
Shire HGT January 2006 - January 2008
berlex oncology 2003 - 2006
Skills
Pharmaceutical Sales, Oncology, Market Access, Hematology, Biotechnology, Managed Care, Buy, Biopharmaceuticals, KOL development, Gastroenterology, Cardiology, Urology, Orthopedic, Nephrology, Hospital Sales, Rheumatology, Product Launch, Neurology, Dermatology, Pulmonology, Infectious Diseases, Endocrinology, Real Estate Transactions, Pharmaceutical Industry, Sales Effectiveness
Education
University of Missouri-Saint Louis 1992 — 1996
BS, Political science, Biology
Stephen Lisko's Shire HGT Experience August 2009 - October 2012
Job Director of Engineering
Industry Biotechnology
Experience
Crosspoint Engineering July 2005 - Present
Shire HGT August 2009 - October 2012
Anika Therapeutics August 2007 - August 2009
AspenTech July 2000 - May 2003
Honeywell Process Solutions 1996 - 2000
Skills
Validation, GMP, Engineering, Process Engineering, Troubleshooting, Process Improvement, Manufacturing, Programming, Documentation, cGMP, Automation, Problem Solving, PLC, Instrumentation, Commissioning, Requirements Analysis, Change Management, User Interface, Technical Writing
Education
University of South Florida 1988 — 1993
BSChE, Engineering
Crosspoint Engineering July 2005 - Present
Shire HGT August 2009 - October 2012
Anika Therapeutics August 2007 - August 2009
AspenTech July 2000 - May 2003
Honeywell Process Solutions 1996 - 2000
Skills
Validation, GMP, Engineering, Process Engineering, Troubleshooting, Process Improvement, Manufacturing, Programming, Documentation, cGMP, Automation, Problem Solving, PLC, Instrumentation, Commissioning, Requirements Analysis, Change Management, User Interface, Technical Writing
Education
University of South Florida 1988 — 1993
BSChE, Engineering
Brian Cowsert's Shire HGT Experience March 2014 - Present
Job Experienced Biotech Sales | Specialty Sales | Product Launch | Rare Disease | Pharmacist
Industry Biotechnology
Experience
Shire HGT March 2014 - Present
Genzyme April 2013 - March 2014
Affymax April 2012 - April 2013
Sunovion Pharmaceuticals Inc. November 2010 - April 2012
Genzyme October 2007 - November 2010
Sepracor 2005 - 2007
Skills
Nephrology, Pharmaceutical Sales, Pulmonology, Endocrinology, Neurology, Gastroenterology, Managed Care, Pharmaceutical Industry, Allergy, Biotechnology Industry, Pharmacy Practice, Launch Products, Hospital Sales, Diabetes, Buy & Bill, Hospitals, Pediatrics, Biotechnology
Education
University of South Carolina-Columbia 1989 — 1991
BS, Pharmacy
The Citadel 1984 — 1988
BS, Biology
Shire HGT March 2014 - Present
Genzyme April 2013 - March 2014
Affymax April 2012 - April 2013
Sunovion Pharmaceuticals Inc. November 2010 - April 2012
Genzyme October 2007 - November 2010
Sepracor 2005 - 2007
Skills
Nephrology, Pharmaceutical Sales, Pulmonology, Endocrinology, Neurology, Gastroenterology, Managed Care, Pharmaceutical Industry, Allergy, Biotechnology Industry, Pharmacy Practice, Launch Products, Hospital Sales, Diabetes, Buy & Bill, Hospitals, Pediatrics, Biotechnology
Education
University of South Carolina-Columbia 1989 — 1991
BS, Pharmacy
The Citadel 1984 — 1988
BS, Biology
Charlton Lewis's Shire HGT Experience October 2011 - Present
Job Tech Shire HGT Pharmaceuticals
Industry Biotechnology
Experience
Shire HGT October 2011 - Present
shire pharmaceuticals 2006 - 2011
Skills
21 CFR Part 11, Biotechnology, CAPA, Change Control, FDA, GMP, Kaizen, LIMS, Pharmaceutical Industry, Sop, Technology Transfer, Trackwise, Validation, Biopharmaceuticals, Regulatory Affairs, Regulatory Submissions, Quality Assurance, V&V, GLP, TrackWise, SOP
Education
University of Dayton
Shire HGT October 2011 - Present
shire pharmaceuticals 2006 - 2011
Skills
21 CFR Part 11, Biotechnology, CAPA, Change Control, FDA, GMP, Kaizen, LIMS, Pharmaceutical Industry, Sop, Technology Transfer, Trackwise, Validation, Biopharmaceuticals, Regulatory Affairs, Regulatory Submissions, Quality Assurance, V&V, GLP, TrackWise, SOP
Education
University of Dayton
Cindy Ochs's Shire HGT Experience June 2012 - Present
Job Senior Case Manager at Shire
Industry Biotechnology
Experience
Shire HGT June 2012 - Present
Shire HGT July 2011 - Present
Genzyme May 1991 - November 2010
Genzyme 2002 - 2010
Genzyme 2000 - 2002
Genzyme 1996 - 2000
Genzyme 1991 - 1996
Private Healthcare Systems 1990 - 1990
New Medico Greater Boston 1989 - 1990
Public Employee Retirement Administration 1988 - 1989
Skills
Case Management, Biotechnology, Pharmaceuticals, Insurance, Pharmaceutical Industry, Managed Care, Case Managment, Nursing, Home Care, Treatment, Training, Leadership, Healthcare, Cross-functional Team..., Patient Advocacy, Neurology, Hospitals, Management
Education
University of Bridgeport 1977 — 1980
BSN, Nursing
Ardsley High School
Shire HGT June 2012 - Present
Shire HGT July 2011 - Present
Genzyme May 1991 - November 2010
Genzyme 2002 - 2010
Genzyme 2000 - 2002
Genzyme 1996 - 2000
Genzyme 1991 - 1996
Private Healthcare Systems 1990 - 1990
New Medico Greater Boston 1989 - 1990
Public Employee Retirement Administration 1988 - 1989
Skills
Case Management, Biotechnology, Pharmaceuticals, Insurance, Pharmaceutical Industry, Managed Care, Case Managment, Nursing, Home Care, Treatment, Training, Leadership, Healthcare, Cross-functional Team..., Patient Advocacy, Neurology, Hospitals, Management
Education
University of Bridgeport 1977 — 1980
BSN, Nursing
Ardsley High School
Steve Taliadouros's Shire HGT Experience March 2013 - January 2015
Job Tech Transfer Manager at Shire HGT
Industry Biotechnology
Experience
Shire Pharmaceuticals January 2015 - Present
Shire HGT March 2013 - January 2015
Lonza June 2012 - March 2013
Shire HGT April 2011 - May 2012
Genzyme July 2009 - February 2011
Genzyme October 2006 - July 2009
Genzyme June 2004 - October 2006
Genzyme September 2001 - June 2004
Genzyme May 1999 - September 2001
Genzyme September 1997 - May 1999
Skills
Manufacturing, Validation, GMP, CAPA, Aseptic Processing, Biotechnology, Change Control, Sop, 21 CFR Part 11, Technology Transfer, Root Cause Analysis, Cleaning Validation, Trackwise, Purification, Cell Culture, ISO, Protein Purification, Aseptic Technique, Sterilization, CIP
Education
University of Massachusetts Lowell 1995 — 2004
Mechanical Engineering and Electrical Engineering
Minuteman Science and Technology Center 1992 — 1995
Cert, Electro-Mechanical Robotics
Shire Pharmaceuticals January 2015 - Present
Shire HGT March 2013 - January 2015
Lonza June 2012 - March 2013
Shire HGT April 2011 - May 2012
Genzyme July 2009 - February 2011
Genzyme October 2006 - July 2009
Genzyme June 2004 - October 2006
Genzyme September 2001 - June 2004
Genzyme May 1999 - September 2001
Genzyme September 1997 - May 1999
Skills
Manufacturing, Validation, GMP, CAPA, Aseptic Processing, Biotechnology, Change Control, Sop, 21 CFR Part 11, Technology Transfer, Root Cause Analysis, Cleaning Validation, Trackwise, Purification, Cell Culture, ISO, Protein Purification, Aseptic Technique, Sterilization, CIP
Education
University of Massachusetts Lowell 1995 — 2004
Mechanical Engineering and Electrical Engineering
Minuteman Science and Technology Center 1992 — 1995
Cert, Electro-Mechanical Robotics
Douglas Donaldson's Shire HGT Experience Research AssistantAbbott LaboratoriesMay 2010 - September 2010
Job Research Associate at Shire HGT
Industry Biotechnology
Experience
Shire HGT Research AssistantAbbott LaboratoriesMay 2010 - September 2010
Monsanto January 2010 - April 2010
RI Analytical September 2005 - June 2006
Microtest Laboratories September 2004 - June 2005
Education
University of Connecticut 2006 — 2010
Masters, Cell Biology/Immunology
Shire HGT Research AssistantAbbott LaboratoriesMay 2010 - September 2010
Monsanto January 2010 - April 2010
RI Analytical September 2005 - June 2006
Microtest Laboratories September 2004 - June 2005
Education
University of Connecticut 2006 — 2010
Masters, Cell Biology/Immunology
Rebecca Cade's Shire HGT Experience April 2007 - Present
Job Senior Development Specialist II at Shire
Industry Biotechnology
Experience
Shire April 2013 - Present
Shire HGT April 2007 - Present
Mallinckrodt January 1999 - March 2007
Skills
Biotechnology, Quality Control
Education
University of Missouri-Saint Louis 2004 — 2006
M.Ed, Counseling
Truman State University 1994 — 1998
Bachelors of Science, Chemistry
Shire April 2013 - Present
Shire HGT April 2007 - Present
Mallinckrodt January 1999 - March 2007
Skills
Biotechnology, Quality Control
Education
University of Missouri-Saint Louis 2004 — 2006
M.Ed, Counseling
Truman State University 1994 — 1998
Bachelors of Science, Chemistry
Nicholas Pelletier, CCRA's Shire HGT Experience March 2012 - July 2013
Job Senior Clinical Operations Lead at Biogen
Industry Biotechnology
Experience
Biogen June 2015 - Present
Biogen Idec July 2013 - June 2015
Shire HGT March 2012 - July 2013
Shire HGT January 2011 - February 2012
Shire HGT November 2009 - January 2011
Shire HGT May 2009 - November 2009
PAREXEL November 2007 - April 2009
Skills
CCRA
Education
University of Massachusetts, Amherst 2002 — 2006
B.S., Psychology
Biogen June 2015 - Present
Biogen Idec July 2013 - June 2015
Shire HGT March 2012 - July 2013
Shire HGT January 2011 - February 2012
Shire HGT November 2009 - January 2011
Shire HGT May 2009 - November 2009
PAREXEL November 2007 - April 2009
Skills
CCRA
Education
University of Massachusetts, Amherst 2002 — 2006
B.S., Psychology
Phillip Durkin's Shire HGT Experience January 2012 - Present
Job Manufacturing Supervisor at Shire HGT
Industry
Experience
Shire HGT January 2012 - Present
United States Army July 2010 - July 2011
Skills
Customer Service, Army, Team Leadership, Training, Military, NATO, Afghanistan, Military Training, Security Clearance, Military Logistics, Organizational..., Military Experience, Operational Planning, Military Operations, Intelligence, DoD
Education
University of Richmond 2002 — 2006
history
Shire HGT January 2012 - Present
United States Army July 2010 - July 2011
Skills
Customer Service, Army, Team Leadership, Training, Military, NATO, Afghanistan, Military Training, Security Clearance, Military Logistics, Organizational..., Military Experience, Operational Planning, Military Operations, Intelligence, DoD
Education
University of Richmond 2002 — 2006
history
Dustin Sorel's Shire HGT Experience May 2011 - Present
Job Manufacturing Supervisor at Shire Pharmaceuticals
Industry Pharmaceuticals
Experience
Shire HGT May 2011 - Present
Shire HGT March 2009 - May 2011
Shire HGT 2007 - 2009
Shire HGT 2006 - 2007
Shire HGT 2004 - 2006
BJ's Wholesale Club 2001 - 2004
Skills
Cell Culture, Manufacturing, GMP, Validation, CAPA, Change Control, Central Services, LIMS, Trackwise, Valgenesis, Training, ERP, FDA, 21 CFR Part 11, Sop, Biotechnology
Education
University of Massachusetts Dartmouth 1997 — 2001
Bachelor's degree, Computer Engineering
Shire HGT May 2011 - Present
Shire HGT March 2009 - May 2011
Shire HGT 2007 - 2009
Shire HGT 2006 - 2007
Shire HGT 2004 - 2006
BJ's Wholesale Club 2001 - 2004
Skills
Cell Culture, Manufacturing, GMP, Validation, CAPA, Change Control, Central Services, LIMS, Trackwise, Valgenesis, Training, ERP, FDA, 21 CFR Part 11, Sop, Biotechnology
Education
University of Massachusetts Dartmouth 1997 — 2001
Bachelor's degree, Computer Engineering
Charlie Drake's Shire HGT Experience April 2011 - March 2015
Job Tech I BioProcess Division @ Xcelience Tampa,Fl
Industry Biotechnology
Experience
Shire HGT April 2011 - March 2015
Genzyme May 2009 - April 2011
Skills
cGMP practices, cGMP manufacturing, Manufacturing Operations, Training, Computer Proficiency, Deviation Management, Personnel Supervision, Delivering on time, SOP authoring, Dispute Resolution, Depth Filtration, Ultrafiltration, Diafiltration, Virus Removal, Chromatography, Unicorn, Delta V, LIMS, Inventory Accuracy, Inventory Control, SAP, Drug Product, Biopharmaceuticals
Education
University of New Hampshire 1998 — 2000
Associate's degree, Business Administration and Management, General
Shire HGT April 2011 - March 2015
Genzyme May 2009 - April 2011
Skills
cGMP practices, cGMP manufacturing, Manufacturing Operations, Training, Computer Proficiency, Deviation Management, Personnel Supervision, Delivering on time, SOP authoring, Dispute Resolution, Depth Filtration, Ultrafiltration, Diafiltration, Virus Removal, Chromatography, Unicorn, Delta V, LIMS, Inventory Accuracy, Inventory Control, SAP, Drug Product, Biopharmaceuticals
Education
University of New Hampshire 1998 — 2000
Associate's degree, Business Administration and Management, General
Aerotek
Honeywell Aerospace
BE Aerospace
CoStar Group
Mohawk Industries
TruGreen
Transwestern
Sierra Nevada Corporation