Shire Regenerative Medicine (formerly Advanced BioHealing)
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Shire Regenerative Medicine (formerly Advanced BioHealing) Employees
Employee
Years
Job
Industry
Brandy Lewis Brandy Lewis's Shire Regenerative Medicine (formerly Advanced BioHealing) Experience November 2010 - March 2013
Job Principal Quality Consultant and Director, Quality Consulting at Thirteen Consulting Group, Inc.
Industry Pharmaceuticals
Experience
Thirteen Consulting Group, Inc. September 2014 - Present
Evofem and Cosmederm Biosciences September 2013 - July 2014
Shire Regenerative Medicine March 2013 - September 2013
Shire Regenerative Medicine (formerly Advanced BioHealing) November 2010 - March 2013
Life Technologies March 2009 - November 2010
Kalypsys July 2007 - March 2009
Anadys Pharmaceuticals January 2005 - July 2007
Favrille August 2002 - December 2004
Agouron Pharmaceuticals July 1996 - August 2001
Pfizer 2000 - 2001
Skills
GMP, Biotechnology, FDA, Technology Transfer, Pharmaceutical Industry, CAPA, Aseptic Processing, GLP, Lifesciences, Quality System, HPLC, Sop, Validation, Change Control, Analytical Chemistry, 21 CFR Part 11, Computer System..., V&V, Regulatory Affairs, Biopharmaceuticals, Quality Auditing, Medical Devices, Quality Control, Batch Records, GxP, Regulatory Submissions, Quality Assurance, ISO 13485, Clinical Trials, IND, Drug Development, Biologics, Trackwise, cGMP manufacturing, GAMP, GCP, SOP, Life Sciences
Education
University of San Diego 1988 — 1992
BA, Chemistry
Thirteen Consulting Group, Inc. September 2014 - Present
Evofem and Cosmederm Biosciences September 2013 - July 2014
Shire Regenerative Medicine March 2013 - September 2013
Shire Regenerative Medicine (formerly Advanced BioHealing) November 2010 - March 2013
Life Technologies March 2009 - November 2010
Kalypsys July 2007 - March 2009
Anadys Pharmaceuticals January 2005 - July 2007
Favrille August 2002 - December 2004
Agouron Pharmaceuticals July 1996 - August 2001
Pfizer 2000 - 2001
Skills
GMP, Biotechnology, FDA, Technology Transfer, Pharmaceutical Industry, CAPA, Aseptic Processing, GLP, Lifesciences, Quality System, HPLC, Sop, Validation, Change Control, Analytical Chemistry, 21 CFR Part 11, Computer System..., V&V, Regulatory Affairs, Biopharmaceuticals, Quality Auditing, Medical Devices, Quality Control, Batch Records, GxP, Regulatory Submissions, Quality Assurance, ISO 13485, Clinical Trials, IND, Drug Development, Biologics, Trackwise, cGMP manufacturing, GAMP, GCP, SOP, Life Sciences
Education
University of San Diego 1988 — 1992
BA, Chemistry
Denmark Vea Denmark Vea's Shire Regenerative Medicine (formerly Advanced BioHealing) Experience 2011 - 2014
Job Cost Accounting Manager at Obalon Therapeutics
Industry Medical Devices
Experience
Obalon Therapeutics 2014 - Present
Aurora Spine 2014 - Present
Shire Regenerative Medicine (Formerly Advanced BioHealing) 2011 - 2014
ResMed 2010 - 2010
Teledyne - RD Instruments 2006 - 2009
Mountain High Hosiery, Ltd. 2005 - 2006
COHU Electronics, Inc. 2002 - 2005
Kollmorgen/Magnedyne 1998 - 2001
Kollmorgen/Magnedyne 1997 - 1998
Skills
Cost Accounting, Accounting, Auditing, ERP, GAAP, Financial Reporting, Account Reconciliation, Forecasting, Sarbanes-Oxley Act, Microsoft Office, Budgets, Financial Analysis, Sarbanes-Oxley, Process Improvement, General Ledger, Analysis, Internal Audit, Manufacturing Cost, QAD, Essbase, Accounts Payable, Variance Analysis, TM1, Cognos, Oracle Applications, Cost Management, Corporate FP&A, JD Edwards, Blackline, Windows, Capitalized Variance, ERP Implementations
Education
University of Redlands 2000 — 2002
MBA, Business Administration
California State University-San Marcos - College of Business Administration 1995 — 1997
BS, Business Administration - emphasis: Accounting
San Diego State University-California State University 1988 — 1991
Business Administration
Becker CPA Review Courses
Obalon Therapeutics 2014 - Present
Aurora Spine 2014 - Present
Shire Regenerative Medicine (Formerly Advanced BioHealing) 2011 - 2014
ResMed 2010 - 2010
Teledyne - RD Instruments 2006 - 2009
Mountain High Hosiery, Ltd. 2005 - 2006
COHU Electronics, Inc. 2002 - 2005
Kollmorgen/Magnedyne 1998 - 2001
Kollmorgen/Magnedyne 1997 - 1998
Skills
Cost Accounting, Accounting, Auditing, ERP, GAAP, Financial Reporting, Account Reconciliation, Forecasting, Sarbanes-Oxley Act, Microsoft Office, Budgets, Financial Analysis, Sarbanes-Oxley, Process Improvement, General Ledger, Analysis, Internal Audit, Manufacturing Cost, QAD, Essbase, Accounts Payable, Variance Analysis, TM1, Cognos, Oracle Applications, Cost Management, Corporate FP&A, JD Edwards, Blackline, Windows, Capitalized Variance, ERP Implementations
Education
University of Redlands 2000 — 2002
MBA, Business Administration
California State University-San Marcos - College of Business Administration 1995 — 1997
BS, Business Administration - emphasis: Accounting
San Diego State University-California State University 1988 — 1991
Business Administration
Becker CPA Review Courses
Coleen Grant Coleen Grant's Shire Regenerative Medicine (formerly Advanced BioHealing) Experience April 2011 - February 2013
Job Marketing Coordinator at Retrophin
Industry Marketing and Advertising
Experience
Retrophin July 2014 - Present
Shire Regenerative Medicine February 2013 - March 2014
Shire Regenerative Medicine (formerly Advanced BioHealing) April 2011 - February 2013
CareFusion (formerly Cardinal Health and Alaris Medical Systems) April 2006 - October 2010
ALARIS Medical Systems October 2000 - April 2006
Adecco June 2000 - October 2000
Pottery Barn July 1998 - May 2000
Victoria's Secret 1992 - 1998
Skills
Excel, Problem Solving, Microsoft Office, Word, PowerPoint, Outlook, Budgeting, Microsoft Word, Budgets, Microsoft Excel, Marketing, Product Launch, Visio, Medical Devices, Sales, Market Research, Healthcare, Customer Service, Selling, Team Building, Marketing Strategy, Management, Strategic Planning, Lean Manufacturing, Product Development, Project Planning, Training, Program Management, Public Speaking, Time Management, Project Management
Education
San Jose State University
Bachelor of Science, Business Marketing
Retrophin July 2014 - Present
Shire Regenerative Medicine February 2013 - March 2014
Shire Regenerative Medicine (formerly Advanced BioHealing) April 2011 - February 2013
CareFusion (formerly Cardinal Health and Alaris Medical Systems) April 2006 - October 2010
ALARIS Medical Systems October 2000 - April 2006
Adecco June 2000 - October 2000
Pottery Barn July 1998 - May 2000
Victoria's Secret 1992 - 1998
Skills
Excel, Problem Solving, Microsoft Office, Word, PowerPoint, Outlook, Budgeting, Microsoft Word, Budgets, Microsoft Excel, Marketing, Product Launch, Visio, Medical Devices, Sales, Market Research, Healthcare, Customer Service, Selling, Team Building, Marketing Strategy, Management, Strategic Planning, Lean Manufacturing, Product Development, Project Planning, Training, Program Management, Public Speaking, Time Management, Project Management
Education
San Jose State University
Bachelor of Science, Business Marketing
LySandra Schleicher LySandra Schleicher's Shire Regenerative Medicine (formerly Advanced BioHealing) Experience 2011 - April 2014
Job Manufacturing Supervisor at Organogenesis Inc.
Industry Biotechnology
Experience
Organogenesis Inc. April 2014 - Present
Shire Regenerative Medicine (formerly Advanced BioHealing) 2011 - April 2014
Advanced BioHealing 2011 - 2011
Advanced BioHealing 2008 - 2011
Progenics Pharmaceuticals 2006 - 2008
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2005 - 2006
Regeneron Pharmaceuticals 2000 - 2005
University at Albany 1999 - 2000
University at Albany 1997 - 1999
Skills
GMP, Aseptic Processing, Biotechnology, SOP, FDA, Validation, Cell Culture, Pharmaceutical Industry, Biopharmaceuticals, Life Sciences, Project Management, Risk Management, CAPAs, Investigations, Quality Assurance, Change Management, Team Management, Team Leadership, Technical Leadership, Performance Management, Organizational Culture, Communication, Cell, Filtration, Sop, Manufacturing, Tissue Culture, Laboratory, Aseptic Technique, Purification
Education
State University of New York at Albany
BA, Behavioral Neuroscience
Organogenesis Inc. April 2014 - Present
Shire Regenerative Medicine (formerly Advanced BioHealing) 2011 - April 2014
Advanced BioHealing 2011 - 2011
Advanced BioHealing 2008 - 2011
Progenics Pharmaceuticals 2006 - 2008
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company 2005 - 2006
Regeneron Pharmaceuticals 2000 - 2005
University at Albany 1999 - 2000
University at Albany 1997 - 1999
Skills
GMP, Aseptic Processing, Biotechnology, SOP, FDA, Validation, Cell Culture, Pharmaceutical Industry, Biopharmaceuticals, Life Sciences, Project Management, Risk Management, CAPAs, Investigations, Quality Assurance, Change Management, Team Management, Team Leadership, Technical Leadership, Performance Management, Organizational Culture, Communication, Cell, Filtration, Sop, Manufacturing, Tissue Culture, Laboratory, Aseptic Technique, Purification
Education
State University of New York at Albany
BA, Behavioral Neuroscience
Micke Daniels Micke Daniels's Shire Regenerative Medicine (formerly Advanced BioHealing) Experience January 2007 - March 2014
Job Versatile Customer Service Manager | Customer Service & Call Center Team Management | Avid Animal Lover
Industry Medical Devices
Experience
Creating strong and sustainable Customer Service teams in multiple industries March 2014 - Present
Shire Regenerative Medicine (formerly Advanced BioHealing) January 2007 - March 2014
Skills
Medical Devices, Sales Operations, Team Leadership, Pharmaceutical Industry, Customer Service, Process Improvement, Healthcare, Product Launch, Sales Management, Account Management, Managed Care, Cross-functional Team..., Pharmaceutical Sales, Capital Equipment, Biotechnology
Education
City University of NY - Queens College
BA, Art History, Honors Degree
State University of New York at Binghamton
Art / Art History / General Studies
Creating strong and sustainable Customer Service teams in multiple industries March 2014 - Present
Shire Regenerative Medicine (formerly Advanced BioHealing) January 2007 - March 2014
Skills
Medical Devices, Sales Operations, Team Leadership, Pharmaceutical Industry, Customer Service, Process Improvement, Healthcare, Product Launch, Sales Management, Account Management, Managed Care, Cross-functional Team..., Pharmaceutical Sales, Capital Equipment, Biotechnology
Education
City University of NY - Queens College
BA, Art History, Honors Degree
State University of New York at Binghamton
Art / Art History / General Studies
Lindsey Saxon Lindsey Saxon's Shire Regenerative Medicine (formerly Advanced BioHealing) Experience May 2009 - April 2013
Job Independent Marketing Communications Consultant
Industry Biotechnology
Experience
Consultant January 2015 - Present
Nanosphere May 2013 - January 2015
Shire Regenerative Medicine (formerly Advanced BioHealing) May 2009 - April 2013
Eastwick Communications January 2006 - March 2009
Coakley Heagerty January 2005 - June 2005
Skills
Corporate Communications, Media Relations, Public Relations, Strategic Communications, Social Media, Strategy, Crisis Communications, Marketing Communications, Internal Communications, Press Releases, Social Media Marketing, Marketing Strategy, Analyst Relations, Integrated Marketing, Event Management, Event Planning, Communication Training, Messaging, Public Speaking, Social Networking, Thought Leadership, Cision, Reputation Management, Journalism, Product Launch, Public Affairs, Copywriting, Blogging, Content Management, Message Development, Copy Editing, Market Research, Campaigns, Content Development, Editing
Education
Santa Clara University 2002 — 2006
BA, Communications, Political Science
Consultant January 2015 - Present
Nanosphere May 2013 - January 2015
Shire Regenerative Medicine (formerly Advanced BioHealing) May 2009 - April 2013
Eastwick Communications January 2006 - March 2009
Coakley Heagerty January 2005 - June 2005
Skills
Corporate Communications, Media Relations, Public Relations, Strategic Communications, Social Media, Strategy, Crisis Communications, Marketing Communications, Internal Communications, Press Releases, Social Media Marketing, Marketing Strategy, Analyst Relations, Integrated Marketing, Event Management, Event Planning, Communication Training, Messaging, Public Speaking, Social Networking, Thought Leadership, Cision, Reputation Management, Journalism, Product Launch, Public Affairs, Copywriting, Blogging, Content Management, Message Development, Copy Editing, Market Research, Campaigns, Content Development, Editing
Education
Santa Clara University 2002 — 2006
BA, Communications, Political Science
Vincent Pipa Vincent Pipa's Shire Regenerative Medicine (formerly Advanced BioHealing) Experience October 2011 - April 2013
Job Principal Account Executive at Medtronic
Industry Medical Devices
Experience
Medtronic January 2015 - Present
Covidien April 2013 - January 2015
Shire Regenerative Medicine (formerly Advanced BioHealing) October 2011 - April 2013
Covidien December 2003 - October 2011
GE Healthcare August 2001 - December 2003
Getinge USA, Inc August 1999 - August 2001
Skills
Medical Devices, Capital Equipment, Disposables, Surgeons, C Suite, Building Relationships, Strategic Partnerships, Team Leadership, Situational Leadership, Strategic Planning, Business Development, Product Launch, Contract Negotiation, Selling, Sales Process, Market Development, Hospitals, Operating Room, Healthcare, Surgery, Sales Force Development, Urology, Sales, CRM, Pharmaceutical Sales, Orthopedic, Management, Cardiology, Cold Calling, Sales Operations, Sales Management, Vascular, Cross-functional Team..., Clinical Research, Capital Equipment Sales
Education
Cleveland State University 1990 — 1993
BBA, Finance
Charles F. Brush High School 1986 — 1989
Medtronic January 2015 - Present
Covidien April 2013 - January 2015
Shire Regenerative Medicine (formerly Advanced BioHealing) October 2011 - April 2013
Covidien December 2003 - October 2011
GE Healthcare August 2001 - December 2003
Getinge USA, Inc August 1999 - August 2001
Skills
Medical Devices, Capital Equipment, Disposables, Surgeons, C Suite, Building Relationships, Strategic Partnerships, Team Leadership, Situational Leadership, Strategic Planning, Business Development, Product Launch, Contract Negotiation, Selling, Sales Process, Market Development, Hospitals, Operating Room, Healthcare, Surgery, Sales Force Development, Urology, Sales, CRM, Pharmaceutical Sales, Orthopedic, Management, Cardiology, Cold Calling, Sales Operations, Sales Management, Vascular, Cross-functional Team..., Clinical Research, Capital Equipment Sales
Education
Cleveland State University 1990 — 1993
BBA, Finance
Charles F. Brush High School 1986 — 1989
April Jocson Mendiola April Jocson Mendiola's Shire Regenerative Medicine (formerly Advanced BioHealing) Experience November 2012 - August 2013
Job Process Development Biologist
Industry Biotechnology
Experience
Gilead Sciences January 2014 - Present
Your Beauty By Nature August 2007 - Present
Organic and Natural Enterprises 2007 - Present
Shire Pharmaceuticals August 2013 - December 2013
Shire Regenerative Medicine (formerly Advanced BioHealing) November 2012 - August 2013
Shire Regenerative Medicine (formerly Advanced BioHealing) September 2011 - November 2012
Althea Technologies October 2010 - September 2011
Althea Technologies April 2008 - October 2010
Healthy Adventures Foundation February 2008 - August 2009
Eli Lilly September 2005 - April 2008
Skills
Fermentation, Cell Culture, Technology Transfer, Cell, Biotechnology, Lifesciences, Pharmaceutical Industry, GMP, Sop, Medical Devices, Microbiology, Validation, FDA, Biopharmaceuticals, Aseptic Technique, Aseptic Processing, ELISA, Biologics, Quality System, CAPA, Cross-functional Team..., Science, SDS-PAGE, Change Control, Project Management, Protocol, Process Improvement, Protein Expression, Manufacturing, Protein Chemistry, Laboratory, R&D, Drug Discovery
Education
Global College of Natural Medicine 2007 — 2008
N.C.
University of California, San Diego 2004 — 2007
M.A.S.
Crafton Hills College 2001 — 2005
Certification
University of California, Riverside 1998 — 2002
B.S.
Gilead Sciences January 2014 - Present
Your Beauty By Nature August 2007 - Present
Organic and Natural Enterprises 2007 - Present
Shire Pharmaceuticals August 2013 - December 2013
Shire Regenerative Medicine (formerly Advanced BioHealing) November 2012 - August 2013
Shire Regenerative Medicine (formerly Advanced BioHealing) September 2011 - November 2012
Althea Technologies October 2010 - September 2011
Althea Technologies April 2008 - October 2010
Healthy Adventures Foundation February 2008 - August 2009
Eli Lilly September 2005 - April 2008
Skills
Fermentation, Cell Culture, Technology Transfer, Cell, Biotechnology, Lifesciences, Pharmaceutical Industry, GMP, Sop, Medical Devices, Microbiology, Validation, FDA, Biopharmaceuticals, Aseptic Technique, Aseptic Processing, ELISA, Biologics, Quality System, CAPA, Cross-functional Team..., Science, SDS-PAGE, Change Control, Project Management, Protocol, Process Improvement, Protein Expression, Manufacturing, Protein Chemistry, Laboratory, R&D, Drug Discovery
Education
Global College of Natural Medicine 2007 — 2008
N.C.
University of California, San Diego 2004 — 2007
M.A.S.
Crafton Hills College 2001 — 2005
Certification
University of California, Riverside 1998 — 2002
B.S.
Casey Mount Casey Mount's Shire Regenerative Medicine (formerly Advanced BioHealing) Experience February 2013 - April 2014
Job Project Engineer
Industry Mechanical or Industrial Engineering
Experience
HMC Farms April 2015 - Present
Lyons Magnus December 2014 - April 2015
Organogenesis Inc. April 2014 - December 2014
Shire Regenerative Medicine (Formerly Advanced Biohealing) February 2013 - April 2014
Cytograft Tissue Engineering, Inc. September 2010 - February 2013
Trinity Fruit Company, Inc. September 2006 - August 2008
Skills
Cell Culture, Biomedical Engineering, Matlab, Solidworks, Biochemistry, Labview, Biomaterials, In Vitro, Laboratory, Minitab, Immunofluorescence, Histology, PCR, Molecular Biology, Microsoft Office, Gel Electrophoresis, Aseptic Technique, COMSOL, Microscopy, Lifesciences, Protein Purification, ELISA, Design of Experiments, Risk Assessment, Quality by Design, CAPA, Change Control, SOP development, Root Cause Analysis, FMEA, cGMP manufacturing, Mechanical Engineering, Medical Devices, Biologics, Bioreactor, FDA, Biotechnology, Life Sciences
Education
California Polytechnic State University-San Luis Obispo 2008 — 2010
M.S., Biomedical Engineering
San Diego State University-California State University 2000 — 2004
B.S., Biology/Chemistry
HMC Farms April 2015 - Present
Lyons Magnus December 2014 - April 2015
Organogenesis Inc. April 2014 - December 2014
Shire Regenerative Medicine (Formerly Advanced Biohealing) February 2013 - April 2014
Cytograft Tissue Engineering, Inc. September 2010 - February 2013
Trinity Fruit Company, Inc. September 2006 - August 2008
Skills
Cell Culture, Biomedical Engineering, Matlab, Solidworks, Biochemistry, Labview, Biomaterials, In Vitro, Laboratory, Minitab, Immunofluorescence, Histology, PCR, Molecular Biology, Microsoft Office, Gel Electrophoresis, Aseptic Technique, COMSOL, Microscopy, Lifesciences, Protein Purification, ELISA, Design of Experiments, Risk Assessment, Quality by Design, CAPA, Change Control, SOP development, Root Cause Analysis, FMEA, cGMP manufacturing, Mechanical Engineering, Medical Devices, Biologics, Bioreactor, FDA, Biotechnology, Life Sciences
Education
California Polytechnic State University-San Luis Obispo 2008 — 2010
M.S., Biomedical Engineering
San Diego State University-California State University 2000 — 2004
B.S., Biology/Chemistry
Jack Van Loon's Shire Regenerative Medicine (formerly Advanced BioHealing) Experience July 2012 - March 2014
Job Clinical Research ProfessionalConsulting
Industry Pharmaceuticals
Experience
Clinical Research Professional March 2014 - Present
Shire Regenerative Medicine (formerly Advanced BioHealing) July 2012 - March 2014
Optimer Pharmaceuticals, Inc. March 2012 - July 2012
PharmaNet Development Group, Inc. April 2011 - March 2012
Biogen Idec, Inc. 2006 - 2011
Quintiles July 1995 - February 2005
Skills
ICH-GCP, Clinical Trials, Regulatory Submissions, Clinical Development, CRO, FDA, Oncology, Drug Development, Lifesciences, Regulatory Affairs, EDC, Clinical Research, Sop, CTMS, Pharmaceutical Industry, GCP
Education
Indiana University-Northwest
Bachelor, Arts & Sciences
Clinical Research Professional March 2014 - Present
Shire Regenerative Medicine (formerly Advanced BioHealing) July 2012 - March 2014
Optimer Pharmaceuticals, Inc. March 2012 - July 2012
PharmaNet Development Group, Inc. April 2011 - March 2012
Biogen Idec, Inc. 2006 - 2011
Quintiles July 1995 - February 2005
Skills
ICH-GCP, Clinical Trials, Regulatory Submissions, Clinical Development, CRO, FDA, Oncology, Drug Development, Lifesciences, Regulatory Affairs, EDC, Clinical Research, Sop, CTMS, Pharmaceutical Industry, GCP
Education
Indiana University-Northwest
Bachelor, Arts & Sciences
Chad Johnson's Shire Regenerative Medicine (formerly Advanced BioHealing) Experience 2010 - 2014
Job Associate Director, Biopharmaceutical Manufacturing at Receptos, Inc.
Industry Biotechnology
Experience
Shire Regenerative Medicine (formerly Advanced BioHealing) 2010 - 2014
Biotech Industry 2006 - 2009
Favrille, Inc. 2002 - 2006
IDEC Pharmaceuticals 2002 - 2002
Advanced Tissue Sciences 1995 - 2002
Molecular Biosystems 1993 - 1995
Biosurface Technology / Genzyme Tissue Repair 1990 - 1993
Skills
GMP, Aseptic Processing, Manufacturing, Clean Rooms, Validation, Cell Culture, Aseptic Technique, Medical Devices, FDA, Operations Management, Biotechnology, Tissue Culture, DMAIC, Biologics, V&V, Biopharmaceuticals, Tissue Engineering, Operational Excellence, Media Preparation, Lean Process Improvement, CAPA, 21 CFR Part 11, Quality System, Technology Transfer, Technical Writing, Mentoring, coaching, ISO 13485, Process Simulation, Sop, Change Control, Coaching, SOP
Education
University of Massachusetts Boston
Bachelor of Science (BS), Biology
Malden Catholic High School
College prep
Shire Regenerative Medicine (formerly Advanced BioHealing) 2010 - 2014
Biotech Industry 2006 - 2009
Favrille, Inc. 2002 - 2006
IDEC Pharmaceuticals 2002 - 2002
Advanced Tissue Sciences 1995 - 2002
Molecular Biosystems 1993 - 1995
Biosurface Technology / Genzyme Tissue Repair 1990 - 1993
Skills
GMP, Aseptic Processing, Manufacturing, Clean Rooms, Validation, Cell Culture, Aseptic Technique, Medical Devices, FDA, Operations Management, Biotechnology, Tissue Culture, DMAIC, Biologics, V&V, Biopharmaceuticals, Tissue Engineering, Operational Excellence, Media Preparation, Lean Process Improvement, CAPA, 21 CFR Part 11, Quality System, Technology Transfer, Technical Writing, Mentoring, coaching, ISO 13485, Process Simulation, Sop, Change Control, Coaching, SOP
Education
University of Massachusetts Boston
Bachelor of Science (BS), Biology
Malden Catholic High School
College prep
Tiffany Crowell's Shire Regenerative Medicine (formerly Advanced BioHealing) Experience June 2010 - January 2013
Job Quality Compliance Specialist
Industry Information Technology and Services
Experience
Dell March 2013 - Present
Shire Regenerative Medicine (formerly Advanced BioHealing) June 2010 - January 2013
Sequenom January 2010 - June 2010
Hologic Gen-Probe May 2009 - February 2010
La Jolla Pharmaceutical Company September 2003 - April 2009
Aradigm Corporation February 2001 - August 2003
Skills
V&V, CAPA, GMP, Validation, Change Control, 21 CFR Part 11, FDA, Sop, Aseptic Processing, Quality System
Education
University of California, Los Angeles 1996 — 2000
Bachelor of Science (B.S.), Psychobiology
Dell March 2013 - Present
Shire Regenerative Medicine (formerly Advanced BioHealing) June 2010 - January 2013
Sequenom January 2010 - June 2010
Hologic Gen-Probe May 2009 - February 2010
La Jolla Pharmaceutical Company September 2003 - April 2009
Aradigm Corporation February 2001 - August 2003
Skills
V&V, CAPA, GMP, Validation, Change Control, 21 CFR Part 11, FDA, Sop, Aseptic Processing, Quality System
Education
University of California, Los Angeles 1996 — 2000
Bachelor of Science (B.S.), Psychobiology
Doug Woelke's Shire Regenerative Medicine (formerly Advanced BioHealing) Experience 2010 - February 2014
Job Associate Director Validation, Calibration, and Maintenance at PaxVax, Inc
Industry Biotechnology
Experience
PaxVax, Inc July 2015 - Present
Self Employed February 2014 - June 2015
Shire Regenerative Medicine (formerly Advanced BioHealing) 2010 - February 2014
SNC Lavalin Pharma February 2008 - March 2010
Favrille May 2006 - February 2008
Skills
CAPA, Validation, Change Control, FDA, 21 CFR Part 11, Sop, Quality System, Biotechnology, Biopharmaceuticals, Pharmaceutical Industry, Budgets, GAMP, Quality Assurance
Education
California State University San Marcos 1993 — 1996
Bachelor's degree
PaxVax, Inc July 2015 - Present
Self Employed February 2014 - June 2015
Shire Regenerative Medicine (formerly Advanced BioHealing) 2010 - February 2014
SNC Lavalin Pharma February 2008 - March 2010
Favrille May 2006 - February 2008
Skills
CAPA, Validation, Change Control, FDA, 21 CFR Part 11, Sop, Quality System, Biotechnology, Biopharmaceuticals, Pharmaceutical Industry, Budgets, GAMP, Quality Assurance
Education
California State University San Marcos 1993 — 1996
Bachelor's degree
Susan Weinbach's Shire Regenerative Medicine (formerly Advanced BioHealing) Experience April 2012 - November 2013
Job Associate Director at Conventus Biomedical Solutions, Inc.
Industry Biotechnology
Experience
Conventus Biomedical Solutions, Inc. November 2013 - Present
Shire Regenerative Medicine (formerly Advanced BioHealing) April 2012 - November 2013
Advanced BioHealing August 2009 - April 2012
Ceregene, Inc. July 2008 - November 2008
Biogen 2007 - 2008
Datafarm Inc 2005 - 2007
Isis Pharmaceuticals 1999 - 2003
Alliance Pharmaceuticals 1998 - 1999
University of California, Santa Barbara 1997 - 1998
University of Rochester Medical Center 1995 - 1997
Skills
FDA, eCTD, Biologics, Combination Products, IMPD, EMEA, CTD
Education
Weizmann Institute of Science 1988 — 1995
Ph.D., Chemistry (Materials and Interfaces)
Princeton University 1985 — 1987
MA, Chemistry
Oberlin College 1982 — 1985
BA, Chemistry
Conventus Biomedical Solutions, Inc. November 2013 - Present
Shire Regenerative Medicine (formerly Advanced BioHealing) April 2012 - November 2013
Advanced BioHealing August 2009 - April 2012
Ceregene, Inc. July 2008 - November 2008
Biogen 2007 - 2008
Datafarm Inc 2005 - 2007
Isis Pharmaceuticals 1999 - 2003
Alliance Pharmaceuticals 1998 - 1999
University of California, Santa Barbara 1997 - 1998
University of Rochester Medical Center 1995 - 1997
Skills
FDA, eCTD, Biologics, Combination Products, IMPD, EMEA, CTD
Education
Weizmann Institute of Science 1988 — 1995
Ph.D., Chemistry (Materials and Interfaces)
Princeton University 1985 — 1987
MA, Chemistry
Oberlin College 1982 — 1985
BA, Chemistry
Kristen Plumb's Shire Regenerative Medicine (formerly Advanced BioHealing) Experience 2012 - Present
Job Sr. Manufacturing Scheduler at Shire Pharmaceuticals
Industry Pharmaceuticals
Experience
Shire Regenerative Medicine (formerly Advanced BioHealing) 2012 - Present
Advanced BioHealing 2009 - 2012
Pacira Pharmaceuticals, Inc. (formerly SkyePharma, Inc.) 2007 - 2008
Pacira Pharmaceuticals, Inc. 2005 - 2007
Pacira Pharmaceuticals, Inc. 2002 - 2005
Skills
Quality Assurance, Forecasting, Validation, Change Control, Software Documentation, GMP, Management, Manufacturing, Master Scheduling, ERP, Sop, Quality Control, V&V, Quality System, Supply Chain Management, 21 CFR Part 11, KPI Dashboards, CAPA, Logistics, SOP, Medical Devices, FDA
Education
University of California, Santa Barbara
Bachelor of Arts, Communication Studies
Shire Regenerative Medicine (formerly Advanced BioHealing) 2012 - Present
Advanced BioHealing 2009 - 2012
Pacira Pharmaceuticals, Inc. (formerly SkyePharma, Inc.) 2007 - 2008
Pacira Pharmaceuticals, Inc. 2005 - 2007
Pacira Pharmaceuticals, Inc. 2002 - 2005
Skills
Quality Assurance, Forecasting, Validation, Change Control, Software Documentation, GMP, Management, Manufacturing, Master Scheduling, ERP, Sop, Quality Control, V&V, Quality System, Supply Chain Management, 21 CFR Part 11, KPI Dashboards, CAPA, Logistics, SOP, Medical Devices, FDA
Education
University of California, Santa Barbara
Bachelor of Arts, Communication Studies
Shea Posey's Shire Regenerative Medicine (formerly Advanced BioHealing) Experience July 2009 - February 2014
Job Customer Solutions Manager at The Medicines Company
Industry Biotechnology
Experience
The Medicines Company October 2014 - Present
Redsky/A-Gen/Osiris February 2014 - October 2014
Shire Regenerative Medicine (formerly Advanced BioHealing) July 2009 - February 2014
Astellas Pharma October 2007 - July 2009
Elan Pharmaceuticals September 2000 - September 2007
Elan 2001 - 2007
Dura Pharmaceuticals 1998 - 2000
Aerotek 1998 - 1998
Skills
Cardiology, Hospitals, Selling Skills, Pharmaceutical Sales, Pharmaceutical Industry, Diabetes, Healthcare, Medical Devices, Hospital Sales, Business Development, Managed Care, Cross-functional Team..., Sales, Sales Operations, Neurology, Selling, Endocrinology, Infectious Diseases, Biotechnology, Sales Effectiveness, Team Leadership, Oncology, Product Launch, Sales Force Development, Rheumatology, Capital Equipment, Urology
Education
Texas A&M University 1994 — 1998
BA, Speech Communications
Texas A&M University
The Medicines Company October 2014 - Present
Redsky/A-Gen/Osiris February 2014 - October 2014
Shire Regenerative Medicine (formerly Advanced BioHealing) July 2009 - February 2014
Astellas Pharma October 2007 - July 2009
Elan Pharmaceuticals September 2000 - September 2007
Elan 2001 - 2007
Dura Pharmaceuticals 1998 - 2000
Aerotek 1998 - 1998
Skills
Cardiology, Hospitals, Selling Skills, Pharmaceutical Sales, Pharmaceutical Industry, Diabetes, Healthcare, Medical Devices, Hospital Sales, Business Development, Managed Care, Cross-functional Team..., Sales, Sales Operations, Neurology, Selling, Endocrinology, Infectious Diseases, Biotechnology, Sales Effectiveness, Team Leadership, Oncology, Product Launch, Sales Force Development, Rheumatology, Capital Equipment, Urology
Education
Texas A&M University 1994 — 1998
BA, Speech Communications
Texas A&M University