Stryker Biotech
Industry: Biotech company
DescriptionFounded: 2003 Parent organization: Stryker Corporation
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Stryker Biotech Employees
Employee
Years
Job
Industry
Yvonne Eaton Yvonne Eaton's Stryker Biotech Experience March 2006 - July 2009
Job QC Sr. Manager at Alexion Pharmaceuticals
Industry Biotechnology
Experience
Alexion Pharmaceuticals November 2012 - Present
Pendulum Interiors June 2011 - Present
Alexion Pharmaceuticals September 2010 - November 2012
Stryker Biotech March 2006 - July 2009
Amgen 2000 - 2006
Immunex 1992 - 1999
Skills
Quality Assurance, PowerPoint, Word, Outlook, Excel, cGMP, Team Leadership, Technical Writing
Education
Rhode Island School of Design 2005 — 2011
Certificate, Interior Design
Western Washington University 1984 — 1991
BS, Biology
Alexion Pharmaceuticals November 2012 - Present
Pendulum Interiors June 2011 - Present
Alexion Pharmaceuticals September 2010 - November 2012
Stryker Biotech March 2006 - July 2009
Amgen 2000 - 2006
Immunex 1992 - 1999
Skills
Quality Assurance, PowerPoint, Word, Outlook, Excel, cGMP, Team Leadership, Technical Writing
Education
Rhode Island School of Design 2005 — 2011
Certificate, Interior Design
Western Washington University 1984 — 1991
BS, Biology
Carl Breuning Carl Breuning's Stryker Biotech Experience 1996 - 1999
Job Field Application Specialist at SarotoriusStedim
Industry Biotechnology
Experience
Sarotorius-Stedim April 2013 - Present
Grifols February 2007 - April 2013
Wyeth Biotech September 2003 - September 2006
Lonza Biologics Inc - Portsmouth 1999 - 2003
Lonza 1999 - 2003
Stryker Biotech 1996 - 1999
Skills
Biopharmaceuticals, Validation, GMP, Technology Transfer, Biotechnology, Aseptic Processing, FDA, Protein Chemistry, Protein Purification, Cell Culture, Purification, Manufacturing, Chromatography, Aseptic Technique, Filtration, Centrifugation, Mammalian Cell Culture, Downstream Processing, Pharmaceutical Industry, LIMS, Cell, Sop, cGMP manufacturing, Column Chromatography, Fermentation, UV/Vis, Drug Delivery, Analytical Chemistry, Cleaning Validation, CAPA
Education
University of New Hampshire 1990 — 1996
Sarotorius-Stedim April 2013 - Present
Grifols February 2007 - April 2013
Wyeth Biotech September 2003 - September 2006
Lonza Biologics Inc - Portsmouth 1999 - 2003
Lonza 1999 - 2003
Stryker Biotech 1996 - 1999
Skills
Biopharmaceuticals, Validation, GMP, Technology Transfer, Biotechnology, Aseptic Processing, FDA, Protein Chemistry, Protein Purification, Cell Culture, Purification, Manufacturing, Chromatography, Aseptic Technique, Filtration, Centrifugation, Mammalian Cell Culture, Downstream Processing, Pharmaceutical Industry, LIMS, Cell, Sop, cGMP manufacturing, Column Chromatography, Fermentation, UV/Vis, Drug Delivery, Analytical Chemistry, Cleaning Validation, CAPA
Education
University of New Hampshire 1990 — 1996
Scott Wright Scott Wright's Stryker Biotech Experience May 2001 - January 2003
Job QA/RA Director, Allen Medical, A HillRom Company
Industry Medical Devices
Experience
Allen Medical, A Hill-Rom Company March 2014 - Present
Boston Scientific Corp May 2013 - March 2014
US Navy Reserve 1997 - 2014
Boston Scientific Corp February 2011 - May 2013
Boston Scientific Corporation October 2006 - March 2011
Boston Scientific Corporation October 2004 - September 2006
Stryker Orthopaedics June 2003 - October 2004
Stryker Biotech May 2001 - January 2003
Stryker Instruments May 1997 - May 2001
USS South Carolina May 1996 - May 1997
Skills
Quality Assurance, Six Sigma, Quality System, Quality Management, FDA, CAPA, ISO 13485, Manufacturing, Medical Devices, Validation, ISO, Testing, Quality Control, FMEA, GMP, V&V, Product Development, Training, SPC, Management, 21 CFR Part 11, Leadership, Lean Manufacturing, Design of Experiments, Iso 9000, Process Engineering, Project Management, ISO 14971, Cross-functional Team...
Education
United States Naval Academy 1988 — 1992
B.S., Ocean Engineering
Western Michigan University 2000 — 2001
MBA, Business
Allen Medical, A Hill-Rom Company March 2014 - Present
Boston Scientific Corp May 2013 - March 2014
US Navy Reserve 1997 - 2014
Boston Scientific Corp February 2011 - May 2013
Boston Scientific Corporation October 2006 - March 2011
Boston Scientific Corporation October 2004 - September 2006
Stryker Orthopaedics June 2003 - October 2004
Stryker Biotech May 2001 - January 2003
Stryker Instruments May 1997 - May 2001
USS South Carolina May 1996 - May 1997
Skills
Quality Assurance, Six Sigma, Quality System, Quality Management, FDA, CAPA, ISO 13485, Manufacturing, Medical Devices, Validation, ISO, Testing, Quality Control, FMEA, GMP, V&V, Product Development, Training, SPC, Management, 21 CFR Part 11, Leadership, Lean Manufacturing, Design of Experiments, Iso 9000, Process Engineering, Project Management, ISO 14971, Cross-functional Team...
Education
United States Naval Academy 1988 — 1992
B.S., Ocean Engineering
Western Michigan University 2000 — 2001
MBA, Business
Martha Larence Martha Larence's Stryker Biotech Experience March 2010 - February 2011
Job Senior Manager Quality Assurance at TESARO
Industry Biotechnology
Experience
TESARO May 2014 - Present
TESARO November 2012 - May 2014
Inspiration Biopharmaceuticals, Inc September 2011 - October 2012
Inspiration Biopharmaceuticals, Inc April 2011 - September 2011
Olympus Biotech February 2011 - April 2011
Stryker Biotech March 2010 - February 2011
Stryker Biotech August 2008 - March 2010
Stryker Biotech April 2006 - August 2008
Abbott Bioresearch Center April 2000 - September 2003
BASF Bioresearch Corporation March 1997 - April 2000
Skills
CAPA, FDA, GMP, GLP, Sop, Quality System, Biotechnology, Validation, 21 CFR Part 11, Pharmaceutical Industry, V&V, Change Control, Regulatory Affairs, ISO 13485, GxP, LIMS, Biopharmaceuticals, Medical Devices, Aseptic Processing, Lifesciences, Protein Purification, Quality Assurance, Computer System..., Quality Control, 21 CFR, Regulatory Submissions, Technology Transfer, IND, GCP, Quality Auditing, SOP
Education
University of Rhode Island 1992 — 1993
Bachelor of Science, Microbiology
University of Rhode Island 1986 — 1990
Bachelor of Science, Human Development, Counseling and Family Studies
TESARO May 2014 - Present
TESARO November 2012 - May 2014
Inspiration Biopharmaceuticals, Inc September 2011 - October 2012
Inspiration Biopharmaceuticals, Inc April 2011 - September 2011
Olympus Biotech February 2011 - April 2011
Stryker Biotech March 2010 - February 2011
Stryker Biotech August 2008 - March 2010
Stryker Biotech April 2006 - August 2008
Abbott Bioresearch Center April 2000 - September 2003
BASF Bioresearch Corporation March 1997 - April 2000
Skills
CAPA, FDA, GMP, GLP, Sop, Quality System, Biotechnology, Validation, 21 CFR Part 11, Pharmaceutical Industry, V&V, Change Control, Regulatory Affairs, ISO 13485, GxP, LIMS, Biopharmaceuticals, Medical Devices, Aseptic Processing, Lifesciences, Protein Purification, Quality Assurance, Computer System..., Quality Control, 21 CFR, Regulatory Submissions, Technology Transfer, IND, GCP, Quality Auditing, SOP
Education
University of Rhode Island 1992 — 1993
Bachelor of Science, Microbiology
University of Rhode Island 1986 — 1990
Bachelor of Science, Human Development, Counseling and Family Studies
Niels Borgstein, MD Niels Borgstein, MD's Stryker Biotech Experience 2006 - 2007
Job Chief Medical Officer (US) at SOTIO
Industry Biotechnology
Experience
SOTIO November 2014 - Present
Millennium: The Takeda Oncology Company 2011 - October 2014
Takeda Pharmaceuticals, Boston 2011 - October 2014
BBC Consulting 2010 - 2010
Acceleron Pharma 2007 - 2010
Stryker Biotech 2006 - 2007
Pfizer Pharmaceuticals 2004 - 2006
Pfizer Global Research & Development 2002 - 2004
Pfizer 1998 - 2002
Pharma Bio-Research, Netherlands 1996 - 1998
Skills
Life Sciences, Oncology, Clinical Trials, Clinical Development, Clinical Research, Drug Development, Cancer, Biopharmaceuticals, Lifesciences, Medicine, Urology, Pharmacology, Biotechnology, GCP, CRO
Education
University of Groningen 1982 — 1990
M.D.
SOTIO November 2014 - Present
Millennium: The Takeda Oncology Company 2011 - October 2014
Takeda Pharmaceuticals, Boston 2011 - October 2014
BBC Consulting 2010 - 2010
Acceleron Pharma 2007 - 2010
Stryker Biotech 2006 - 2007
Pfizer Pharmaceuticals 2004 - 2006
Pfizer Global Research & Development 2002 - 2004
Pfizer 1998 - 2002
Pharma Bio-Research, Netherlands 1996 - 1998
Skills
Life Sciences, Oncology, Clinical Trials, Clinical Development, Clinical Research, Drug Development, Cancer, Biopharmaceuticals, Lifesciences, Medicine, Urology, Pharmacology, Biotechnology, GCP, CRO
Education
University of Groningen 1982 — 1990
M.D.
Bruce Lessley Bruce Lessley's Stryker Biotech Experience June 2010 - November 2011
Job Protein Purification & Analytical Development
Industry Biotechnology
Experience
Northeastern University February 2013 - May 2013
Aura Biosciences December 2011 - November 2012
Stryker Biotech June 2010 - November 2011
Stryker Biotech November 2002 - June 2010
Stryker Biotech December 2000 - November 2002
Stryker Biotech June 2000 - December 2000
Stryker Biotech December 1999 - June 2000
Skills
Protein Chemistry, Purification, Biotechnology, CAPA, GMP, Validation, Biologics, Lifesciences, R&D, Technology Transfer, Sop, Protein Purification, Assay Development, Chromatography, SDS-PAGE, Medical Devices, Cell Culture, HPLC, FDA
Education
The Ohio State University 1972 — 1975
Ph.D., Reproductive Physiology
Northeastern University February 2013 - May 2013
Aura Biosciences December 2011 - November 2012
Stryker Biotech June 2010 - November 2011
Stryker Biotech November 2002 - June 2010
Stryker Biotech December 2000 - November 2002
Stryker Biotech June 2000 - December 2000
Stryker Biotech December 1999 - June 2000
Skills
Protein Chemistry, Purification, Biotechnology, CAPA, GMP, Validation, Biologics, Lifesciences, R&D, Technology Transfer, Sop, Protein Purification, Assay Development, Chromatography, SDS-PAGE, Medical Devices, Cell Culture, HPLC, FDA
Education
The Ohio State University 1972 — 1975
Ph.D., Reproductive Physiology
Wayne Wilson, PhD Wayne Wilson, PhD's Stryker Biotech Experience 2002 - 2004
Job VP Quality, Kalon Biotherapeutics
Industry Pharmaceuticals
Experience
Kalon Biotherapeutics 2013 - Present
Irvine Pharmaceutical Services 2012 - September 2012
Bayer HealthCare 2010 - February 2012
Covance Laboratories 2008 - 2010
Bristol-Myers Squibb, Syracuse NY 2005 - 2008
Stryker Biotech 2002 - 2004
Wyeth Pharmaceuticals 2000 - 2002
Skills
Quality Control, Laboratory, Chemistry, Biotechnology, SOP, Quality Assurance, Team Management, Validation, Molecular Virology, Biopharmaceuticals, Microbiology, Cross-functional Team..., Virology, FDA, Quality Operations
Education
University of Illinois at Chicago
Doctor of Philosophy (PhD), Microbiology
Kalon Biotherapeutics 2013 - Present
Irvine Pharmaceutical Services 2012 - September 2012
Bayer HealthCare 2010 - February 2012
Covance Laboratories 2008 - 2010
Bristol-Myers Squibb, Syracuse NY 2005 - 2008
Stryker Biotech 2002 - 2004
Wyeth Pharmaceuticals 2000 - 2002
Skills
Quality Control, Laboratory, Chemistry, Biotechnology, SOP, Quality Assurance, Team Management, Validation, Molecular Virology, Biopharmaceuticals, Microbiology, Cross-functional Team..., Virology, FDA, Quality Operations
Education
University of Illinois at Chicago
Doctor of Philosophy (PhD), Microbiology
Hang Chu Hang Chu's Stryker Biotech Experience August 2010 - January 2011
Job Pharmaceutial Engineer at McGuff Pharmaceuticals Inc.
Industry Biotechnology
Experience
McGuff Pharmaceuticals May 2014 - Present
Neutrogena September 2011 - December 2013
Olympus Biotech Corporation February 2011 - September 2011
Stryker Biotech August 2010 - January 2011
Validation Technologies, Inc. July 2006 - August 2010
B. Braun Medical December 2004 - June 2006
Skills
Validation, CAPA, cGMP, SOP, 21 CFR Part 11, FDA, GLP, Change Control, Quality Systems, Biotechnology, GxP, Quality Assurance, Root Cause Analysis, CIP, Cleaning Validation, Computer System..., GAMP, Documentation, Technical Writing, Compliance, Risk Assessment, Quality Auditing, Pharmaceutical Industry, Aseptic Processing, Biopharmaceuticals, GMP, V&V, ISO 13485, Sop, Technology Transfer, Quality System, Software Documentation, Medical Devices, Regulatory Requirements, LIMS, Calibration, Regulatory Affairs, Quality Control, FDA GMP, Lifesciences, Chromatography, Microbiology, Vaccines, Sterilization, HPLC, GCP, Process Simulation, Pharmaceutics, Purification, Formulation
Education
University of California, Los Angeles 2001 — 2004
Bachelor of Science, Biology
McGuff Pharmaceuticals May 2014 - Present
Neutrogena September 2011 - December 2013
Olympus Biotech Corporation February 2011 - September 2011
Stryker Biotech August 2010 - January 2011
Validation Technologies, Inc. July 2006 - August 2010
B. Braun Medical December 2004 - June 2006
Skills
Validation, CAPA, cGMP, SOP, 21 CFR Part 11, FDA, GLP, Change Control, Quality Systems, Biotechnology, GxP, Quality Assurance, Root Cause Analysis, CIP, Cleaning Validation, Computer System..., GAMP, Documentation, Technical Writing, Compliance, Risk Assessment, Quality Auditing, Pharmaceutical Industry, Aseptic Processing, Biopharmaceuticals, GMP, V&V, ISO 13485, Sop, Technology Transfer, Quality System, Software Documentation, Medical Devices, Regulatory Requirements, LIMS, Calibration, Regulatory Affairs, Quality Control, FDA GMP, Lifesciences, Chromatography, Microbiology, Vaccines, Sterilization, HPLC, GCP, Process Simulation, Pharmaceutics, Purification, Formulation
Education
University of California, Los Angeles 2001 — 2004
Bachelor of Science, Biology
A. Kyle Kennedy A. Kyle Kennedy's Stryker Biotech Experience 2007 - February 2011
Job
Industry Biotechnology
Experience
Mylan August 2014 - Present
Kennedy Compliance, Inc. 2005 - Present
Olympus Biotech Corporation 2011 - 2014
Stryker Biotech 2007 - February 2011
cGMP Validation, LLC 2000 - 2005
75th Street Brewery 1997 - 2000
Akers Kennedy and Associates 1995 - 2000
Skills
Validation, Sop, Environmental Monitoring, Manufacturing, Management, Team Leadership, Biotechnology, Quality Assurance, Facilities Management, GMP, FDA, Sterilization, V&V, Quality System, ISO 13485, CAPA, Change Control, Computer System..., GxP, Technology Transfer, Aseptic Processing, Biopharmaceuticals, 21 CFR Part 11, Quality Control, Medical Devices, Quality Auditing, Lifesciences, Cleaning Validation, Pharmaceutical Industry, GLP, GAMP, Regulatory Affairs, Validation Master Plans, Quality Management, Cross-functional Team..., Commissioning, Microbiology, FDA GMP, Regulatory Requirements, Software Documentation, Isolators, Quality Risk Management, Equipment Qualification, Process Validation, Training, Depyrogenation, Validation Lifecycle, SOP
Education
Stevens Institute of Technology 2010 — 2012
Master of Science (MS)
University of Missouri-Kansas City
Post-Grad
University of Vermont
BA
Don Bosco Prep High School
Mylan August 2014 - Present
Kennedy Compliance, Inc. 2005 - Present
Olympus Biotech Corporation 2011 - 2014
Stryker Biotech 2007 - February 2011
cGMP Validation, LLC 2000 - 2005
75th Street Brewery 1997 - 2000
Akers Kennedy and Associates 1995 - 2000
Skills
Validation, Sop, Environmental Monitoring, Manufacturing, Management, Team Leadership, Biotechnology, Quality Assurance, Facilities Management, GMP, FDA, Sterilization, V&V, Quality System, ISO 13485, CAPA, Change Control, Computer System..., GxP, Technology Transfer, Aseptic Processing, Biopharmaceuticals, 21 CFR Part 11, Quality Control, Medical Devices, Quality Auditing, Lifesciences, Cleaning Validation, Pharmaceutical Industry, GLP, GAMP, Regulatory Affairs, Validation Master Plans, Quality Management, Cross-functional Team..., Commissioning, Microbiology, FDA GMP, Regulatory Requirements, Software Documentation, Isolators, Quality Risk Management, Equipment Qualification, Process Validation, Training, Depyrogenation, Validation Lifecycle, SOP
Education
Stevens Institute of Technology 2010 — 2012
Master of Science (MS)
University of Missouri-Kansas City
Post-Grad
University of Vermont
BA
Don Bosco Prep High School
Nancy Nutile-McMenemy Nancy Nutile-McMenemy's Stryker Biotech Experience November 2008 - March 2009
Job Owner/Photographer at Photos By Nanci
Industry Photography
Experience
Photos By Nanci January 2005 - Present
the Lebanon Opera House April 2008 - Present
The Vermont Standard August 2010 - Present
Stryker Biotech November 2008 - March 2009
Dartmouth College November 2003 - August 2008
Glycofi, Inc July 2002 - July 2003
Dartmouth College 2000 - 2002
Dartmouth College 1997 - 2000
Dartmouth College 1988 - 1997
Skills
Archive Photography, Concert Photography, Portrait Photography, Underwater Photography, Wedding Photography, Photography, Research, PCR, Magazines, Image Editing, Photos, Photoshop, Photojournalism, Digital Photography, Portraits, Commercial Photography, Travel Photography, Social Media
Education
University of Massachusetts, Amherst 1983 — 1985
M.S., Immunology, Parasitology
University of Massachusetts, Amherst 1979 — 1983
B.S., Animal Science
Photos By Nanci January 2005 - Present
the Lebanon Opera House April 2008 - Present
The Vermont Standard August 2010 - Present
Stryker Biotech November 2008 - March 2009
Dartmouth College November 2003 - August 2008
Glycofi, Inc July 2002 - July 2003
Dartmouth College 2000 - 2002
Dartmouth College 1997 - 2000
Dartmouth College 1988 - 1997
Skills
Archive Photography, Concert Photography, Portrait Photography, Underwater Photography, Wedding Photography, Photography, Research, PCR, Magazines, Image Editing, Photos, Photoshop, Photojournalism, Digital Photography, Portraits, Commercial Photography, Travel Photography, Social Media
Education
University of Massachusetts, Amherst 1983 — 1985
M.S., Immunology, Parasitology
University of Massachusetts, Amherst 1979 — 1983
B.S., Animal Science
John Tatro John Tatro's Stryker Biotech Experience 2009 - 2010
Job Process & Analytical Science Associate at Novo Nordisk
Industry Biotechnology
Experience
Novo Nordisk December 2014 - Present
Olympus Biotech America / Formerly Stryker Biotech February 2000 - June 2014
Stryker Biotech 2009 - 2010
Stryker Biotech 2006 - 2009
Stryker Biotech 2003 - June 2006
Skills
Sop, Manufacturing, GMP, Biopharmaceuticals, FDA, Medical Devices, Quality System, Troubleshooting, Validation, CAPA, Lifesciences, ISO 13485, 21 CFR Part 11, Management, Pharmaceutical Industry, Biotechnology, Cross-functional Team..., Lean Manufacturing, Change Control, Aseptic Processing, V&V, Aseptic Technique, Cleaning Validation, Technology Transfer, GxP, Project Management, GLP, Cell Culture
Education
The University of New Mexico
BS, Biology
Novo Nordisk December 2014 - Present
Olympus Biotech America / Formerly Stryker Biotech February 2000 - June 2014
Stryker Biotech 2009 - 2010
Stryker Biotech 2006 - 2009
Stryker Biotech 2003 - June 2006
Skills
Sop, Manufacturing, GMP, Biopharmaceuticals, FDA, Medical Devices, Quality System, Troubleshooting, Validation, CAPA, Lifesciences, ISO 13485, 21 CFR Part 11, Management, Pharmaceutical Industry, Biotechnology, Cross-functional Team..., Lean Manufacturing, Change Control, Aseptic Processing, V&V, Aseptic Technique, Cleaning Validation, Technology Transfer, GxP, Project Management, GLP, Cell Culture
Education
The University of New Mexico
BS, Biology
Bijan Homayounfar Bijan Homayounfar's Stryker Biotech Experience September 2002 - May 2005
Job President at Sano Medical
Industry Medical Devices
Experience
Sano Medical June 2013 - Present
Baxano August 2011 - May 2013
Aether Innovations March 2011 - July 2011
Bacterin International April 2010 - February 2011
Stryker Orthopaedics June 2005 - April 2010
Stryker Biotech September 2002 - May 2005
TriMed Inc. March 1998 - September 2002
Smith & Nephew Orthopaedics May 1999 - November 2000
DePuy Orthopaedics February 1996 - May 1999
Skills
Operating Room, Surgeons, Orthopedic, Spine, Sales Operations, Product Marketing, Market Development, Medical Devices, Surgical Instruments, Strategy, Capital Equipment, Neurosurgery, Product Launch, Interventional Radiology, Medical Sales, Disposables, Surgery, Orthopedics
Education
University of California, Santa Barbara
BA, Economics
Sano Medical June 2013 - Present
Baxano August 2011 - May 2013
Aether Innovations March 2011 - July 2011
Bacterin International April 2010 - February 2011
Stryker Orthopaedics June 2005 - April 2010
Stryker Biotech September 2002 - May 2005
TriMed Inc. March 1998 - September 2002
Smith & Nephew Orthopaedics May 1999 - November 2000
DePuy Orthopaedics February 1996 - May 1999
Skills
Operating Room, Surgeons, Orthopedic, Spine, Sales Operations, Product Marketing, Market Development, Medical Devices, Surgical Instruments, Strategy, Capital Equipment, Neurosurgery, Product Launch, Interventional Radiology, Medical Sales, Disposables, Surgery, Orthopedics
Education
University of California, Santa Barbara
BA, Economics
Beth J. Cormier Beth J. Cormier's Stryker Biotech Experience October 2006 - December 2007
Job Quality Manager
Industry Biotechnology
Experience
Jordi Labs May 2014 - September 2014
Adecco Engineering & Technical December 2013 - December 2013
Lang Pharma Nutrition, Inc. July 2013 - October 2013
Gemini Staffing Consultants LLC 2012 - 2012
Maetrics, LLC 2012 - 2012
TalentBurst, Inc 2012 - 2012
Smithers Viscient 2011 - 2012
Braintree Laboratories May 2008 - September 2011
Stryker Biotech October 2006 - December 2007
Genzyme September 2003 - October 2006
Skills
Quality Assurance, LIMS, GMP, Quality System, Biotechnology, Microsoft Word, Microsoft Excel, Microsoft Office, Change Control, Livelink, HPLC, FDA, Trackwise, PowerPoint, Adobe Professional, Document Management, NuGenesis, Internal Audit, External Audit, SharePoint, Microsoft Outlook, Plataeu LMS, OECD Section 8.2, SmartCapa, Microsoft PowerPoint, Internal Controls, Internal Audits, External Audits, Material Review Board, EPA 40CFR Parts 160 and..., FDA 21CFR Parts 11, 58,..., Document Control &..., Workingbird Training..., Familiar with ISO 9000..., Intermediate..., Intermediate verbal and..., Review and Release of..., Batch Review and..., Performed Ecological..., Written OJT's, SOPs,..., SOP, Hazardous Waste..., Hazardous Materials..., HazMat shipping,..., Pharmaceutical Industry, CAPA
Education
University of San Diego 1999 — 2003
Bachelor of Arts, Biology
Fairhaven High School 1995 — 1999
Honors/ Fairhaven High School
Jordi Labs May 2014 - September 2014
Adecco Engineering & Technical December 2013 - December 2013
Lang Pharma Nutrition, Inc. July 2013 - October 2013
Gemini Staffing Consultants LLC 2012 - 2012
Maetrics, LLC 2012 - 2012
TalentBurst, Inc 2012 - 2012
Smithers Viscient 2011 - 2012
Braintree Laboratories May 2008 - September 2011
Stryker Biotech October 2006 - December 2007
Genzyme September 2003 - October 2006
Skills
Quality Assurance, LIMS, GMP, Quality System, Biotechnology, Microsoft Word, Microsoft Excel, Microsoft Office, Change Control, Livelink, HPLC, FDA, Trackwise, PowerPoint, Adobe Professional, Document Management, NuGenesis, Internal Audit, External Audit, SharePoint, Microsoft Outlook, Plataeu LMS, OECD Section 8.2, SmartCapa, Microsoft PowerPoint, Internal Controls, Internal Audits, External Audits, Material Review Board, EPA 40CFR Parts 160 and..., FDA 21CFR Parts 11, 58,..., Document Control &..., Workingbird Training..., Familiar with ISO 9000..., Intermediate..., Intermediate verbal and..., Review and Release of..., Batch Review and..., Performed Ecological..., Written OJT's, SOPs,..., SOP, Hazardous Waste..., Hazardous Materials..., HazMat shipping,..., Pharmaceutical Industry, CAPA
Education
University of San Diego 1999 — 2003
Bachelor of Arts, Biology
Fairhaven High School 1995 — 1999
Honors/ Fairhaven High School
Eric DeFelice Eric DeFelice's Stryker Biotech Experience 2008 - 2012
Job Automation Engineer
Industry Biotechnology
Experience
Novo Nordisk April 2015 - Present
Town of Hanover August 2014 - April 2015
Olympus Biotech America February 2012 - August 2014
Upper Valley Equipment Rental 2002 - March 2014
Stryker Biotech 2008 - 2012
Fastenal 2006 - 2008
Skills
Building Automation, Troubleshooting, Process Automation, Loop Checking, PLC Allen Bradley, RSView, RSLogix, Oracle, PID tunning, HMI design, HMI Configuration, Active Directory, Automation, PLC, Process Control, Validation, GMP, Control Systems Design, Allen Bradley, Variable Frequency..., Microsoft Excel, Project Management
Education
Southern New Hampshire University 2002 — 2006
Bachelor's Degree, Business Administration and Organizational Leadership (minor)
Hartford High
Hartford High
Novo Nordisk April 2015 - Present
Town of Hanover August 2014 - April 2015
Olympus Biotech America February 2012 - August 2014
Upper Valley Equipment Rental 2002 - March 2014
Stryker Biotech 2008 - 2012
Fastenal 2006 - 2008
Skills
Building Automation, Troubleshooting, Process Automation, Loop Checking, PLC Allen Bradley, RSView, RSLogix, Oracle, PID tunning, HMI design, HMI Configuration, Active Directory, Automation, PLC, Process Control, Validation, GMP, Control Systems Design, Allen Bradley, Variable Frequency..., Microsoft Excel, Project Management
Education
Southern New Hampshire University 2002 — 2006
Bachelor's Degree, Business Administration and Organizational Leadership (minor)
Hartford High
Hartford High
Carolyn (Fioretti) Marcy Carolyn (Fioretti) Marcy's Stryker Biotech Experience June 2002 - April 2006
Job Sr QC Lead | ASQ CPGP | Seeking New Opportunities | Quality Systems | QC/QA Compliance | RA/CMC | Stability Program Mgmt
Industry Biotechnology
Experience
ARIAD Pharmaceuticals, Inc. July 2015 - Present
Lonza January 2011 - September 2013
Lonza April 2007 - December 2010
Biovest International July 2006 - April 2007
Stryker Biotech June 2002 - April 2006
Alkermes September 1998 - June 2002
Alkermes September 1996 - September 1998
Alkermes December 1995 - September 1996
Verigen Inc. June 1995 - September 1995
Behring Diagnostics (later known as DADE BEHRING) February 1995 - May 1995
Skills
GMP, Validation, FDA, LIMS, HPLC, ELISA, Biotechnology, Assay Development, Stability, UV/Vis, Change Control, Protein Chemistry, Vaccines, GLP, Medical Devices, Cell Culture, Quality System, Quality Assurance, 21 CFR Part 11, SDS-PAGE, ICH guidelines, IND, Biopharmaceuticals, Analytical Method..., Quality Control, Aseptic Technique, Pharmaceutical Industry, Lifesciences, Technology Transfer, Chromatography, CAPA, Document Management, TrackWise, SAP, Outsourced Testing, Combination Products, OOS, Lab Investigations, Acceptance Criteria, Customer Service, OE, Six Sigma, Deviations, Immunoassays, SOP
Education
Stonehill College 1976 — 1980
Bachelor of Science, Biology
Harvard University Extension School
Individual Graduate Level Courses
QPS Institute 2014 — 2014
Master Expert Certification Program
Masconomet Regional High School
ARIAD Pharmaceuticals, Inc. July 2015 - Present
Lonza January 2011 - September 2013
Lonza April 2007 - December 2010
Biovest International July 2006 - April 2007
Stryker Biotech June 2002 - April 2006
Alkermes September 1998 - June 2002
Alkermes September 1996 - September 1998
Alkermes December 1995 - September 1996
Verigen Inc. June 1995 - September 1995
Behring Diagnostics (later known as DADE BEHRING) February 1995 - May 1995
Skills
GMP, Validation, FDA, LIMS, HPLC, ELISA, Biotechnology, Assay Development, Stability, UV/Vis, Change Control, Protein Chemistry, Vaccines, GLP, Medical Devices, Cell Culture, Quality System, Quality Assurance, 21 CFR Part 11, SDS-PAGE, ICH guidelines, IND, Biopharmaceuticals, Analytical Method..., Quality Control, Aseptic Technique, Pharmaceutical Industry, Lifesciences, Technology Transfer, Chromatography, CAPA, Document Management, TrackWise, SAP, Outsourced Testing, Combination Products, OOS, Lab Investigations, Acceptance Criteria, Customer Service, OE, Six Sigma, Deviations, Immunoassays, SOP
Education
Stonehill College 1976 — 1980
Bachelor of Science, Biology
Harvard University Extension School
Individual Graduate Level Courses
QPS Institute 2014 — 2014
Master Expert Certification Program
Masconomet Regional High School
Andrea McFadden Andrea McFadden's Stryker Biotech Experience May 2010 - January 2011
Job Quality Assurance | Biotech | Pharma | FDA Regulations
Industry Pharmaceuticals
Experience
bluebird bio July 2014 - Present
Shire Pharmaceuticals January 2011 - February 2014
Stryker Biotech May 2010 - January 2011
Chemic Laboratories Inc. April 2006 - April 2010
Genzyme February 2005 - April 2006
Skills
GMP, GLP, Validation, HPLC, Sop, CAPA, LIMS, FDA, Method Development, Pharmaceutical Industry, Aseptic Technique, Chemistry, Quality Assurance, Trackwise, 21 CFR Part 11, Change Control, GxP, SOP
Education
University of Delaware 1995 — 2000
Bachelors, Chemistry
bluebird bio July 2014 - Present
Shire Pharmaceuticals January 2011 - February 2014
Stryker Biotech May 2010 - January 2011
Chemic Laboratories Inc. April 2006 - April 2010
Genzyme February 2005 - April 2006
Skills
GMP, GLP, Validation, HPLC, Sop, CAPA, LIMS, FDA, Method Development, Pharmaceutical Industry, Aseptic Technique, Chemistry, Quality Assurance, Trackwise, 21 CFR Part 11, Change Control, GxP, SOP
Education
University of Delaware 1995 — 2000
Bachelors, Chemistry
Allen Pierce, MS, DABT Allen Pierce, MS, DABT's Stryker Biotech Experience September 2010 - January 2011
Job Toxicologist at Alkermes
Industry Biotechnology
Experience
Alkermes July 2013 - Present
Molecular Insight Pharmaceuticals, Inc. November 2011 - February 2013
Olympus Biotech February 2011 - October 2011
Stryker Biotech September 2010 - January 2011
Stryker Biotech October 2005 - September 2010
Stryker Biotech April 1997 - September 2005
CIPR/MGH April 1992 - March 1997
Skills
Toxicology, GLP, Pharmacology, Biotechnology, Life Sciences, Toxicokinetics, Study Design, Regulatory Affairs, Study Monitoring, Pharmacokinetics, Animal Models, Data Analysis, Risk Assessment, Lifesciences, Assay Development, GMP, Oncology, Protocol, Pharmaceutics, Sop, Technology Transfer, Validation, Biomarkers, Biopharmaceuticals, Clinical Development, CRO, Biochemistry, Biologics, Drug Development, Drug Metabolism, FDA, IND, In Vivo, Medical Devices, Pharmaceutical Industry, R, Regulatory Submissions, SOP
Education
The Johns Hopkins University 2010 — 2012
MS, Bioscience Regulatory Affairs
University of Maine 1980 — 1984
BA, Zoology
Alkermes July 2013 - Present
Molecular Insight Pharmaceuticals, Inc. November 2011 - February 2013
Olympus Biotech February 2011 - October 2011
Stryker Biotech September 2010 - January 2011
Stryker Biotech October 2005 - September 2010
Stryker Biotech April 1997 - September 2005
CIPR/MGH April 1992 - March 1997
Skills
Toxicology, GLP, Pharmacology, Biotechnology, Life Sciences, Toxicokinetics, Study Design, Regulatory Affairs, Study Monitoring, Pharmacokinetics, Animal Models, Data Analysis, Risk Assessment, Lifesciences, Assay Development, GMP, Oncology, Protocol, Pharmaceutics, Sop, Technology Transfer, Validation, Biomarkers, Biopharmaceuticals, Clinical Development, CRO, Biochemistry, Biologics, Drug Development, Drug Metabolism, FDA, IND, In Vivo, Medical Devices, Pharmaceutical Industry, R, Regulatory Submissions, SOP
Education
The Johns Hopkins University 2010 — 2012
MS, Bioscience Regulatory Affairs
University of Maine 1980 — 1984
BA, Zoology
Joe Ross Joe Ross's Stryker Biotech Experience April 2007 - May 2008
Job Executive Vice President Global Marketing at LDR Spine
Industry Medical Devices
Experience
LDR Spine January 2013 - Present
LDR Spine December 2010 - December 2012
Axial Biotech August 2008 - December 2010
Stryker Biotech April 2007 - May 2008
DePuy Spine July 2005 - February 2007
DePuy Spine July 2003 - July 2005
Skills
Spine, Medical Devices, Biotechnology, Market Development, Marketing Strategy, Product Launch, New Business Development, Product Management, Product Marketing, Start-ups, Business Development, Orthopedic, Marketing, Leadership, Capital Equipment, Product Development, FDA, Commercialization, Disposables, Brand Management, Surgery, Surgical Instruments, Sales Management, Surgeons, Sales, Global Marketing, Biologics, Operating Room, Neurosurgery, Strategy, Sales Operations, Cross-functional Team...
Education
Troy University 1993 — 1995
MSM, Management
University of Notre Dame 1986 — 1990
Bachelor of Business Administration (B.B.A.), Marketing
LDR Spine January 2013 - Present
LDR Spine December 2010 - December 2012
Axial Biotech August 2008 - December 2010
Stryker Biotech April 2007 - May 2008
DePuy Spine July 2005 - February 2007
DePuy Spine July 2003 - July 2005
Skills
Spine, Medical Devices, Biotechnology, Market Development, Marketing Strategy, Product Launch, New Business Development, Product Management, Product Marketing, Start-ups, Business Development, Orthopedic, Marketing, Leadership, Capital Equipment, Product Development, FDA, Commercialization, Disposables, Brand Management, Surgery, Surgical Instruments, Sales Management, Surgeons, Sales, Global Marketing, Biologics, Operating Room, Neurosurgery, Strategy, Sales Operations, Cross-functional Team...
Education
Troy University 1993 — 1995
MSM, Management
University of Notre Dame 1986 — 1990
Bachelor of Business Administration (B.B.A.), Marketing
Warren Jaworowicz Warren Jaworowicz's Stryker Biotech Experience October 2005 - August 2009
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
Nancy Denison Nancy Denison's Stryker Biotech Experience January 2010 - February 2011
Job Associate Director, Quality Control at Shire HGT
Industry Biotechnology
Experience
Shire HGT July 2012 - Present
Olympus Biotech (formerly Stryker Biotech) February 2011 - July 2012
Stryker Biotech January 2010 - February 2011
Stryker Biotech 2007 - 2010
Stryker Biotech 2007 - 2007
Stryker Biotech 2000 - 2007
Creative Biomolecules 1992 - 1998
Hemagen Diagnostics 1985 - 1987
Seragen Inc 1984 - 1985
Skills
Validation, GMP, Biotechnology, ELISA, R&D, Assay Development, Method Development, Laboratory, FDA, Technology Transfer, Sop, CAPA, Medical Devices, Lifesciences, HPLC, SDS-PAGE, Biopharmaceuticals, Immunoassays, Regulatory Affairs, Purification, Gel Electrophoresis, Quality Control, SOP, Life Sciences
Education
Rochester Institute of Technology 1982 — 1985
MS, Clinical Chemistry
University of Massachusetts Dartmouth 1978 — 1982
BS, Chemistry
Shire HGT July 2012 - Present
Olympus Biotech (formerly Stryker Biotech) February 2011 - July 2012
Stryker Biotech January 2010 - February 2011
Stryker Biotech 2007 - 2010
Stryker Biotech 2007 - 2007
Stryker Biotech 2000 - 2007
Creative Biomolecules 1992 - 1998
Hemagen Diagnostics 1985 - 1987
Seragen Inc 1984 - 1985
Skills
Validation, GMP, Biotechnology, ELISA, R&D, Assay Development, Method Development, Laboratory, FDA, Technology Transfer, Sop, CAPA, Medical Devices, Lifesciences, HPLC, SDS-PAGE, Biopharmaceuticals, Immunoassays, Regulatory Affairs, Purification, Gel Electrophoresis, Quality Control, SOP, Life Sciences
Education
Rochester Institute of Technology 1982 — 1985
MS, Clinical Chemistry
University of Massachusetts Dartmouth 1978 — 1982
BS, Chemistry
Tracy K. Blumen Tracy K. Blumen's Stryker Biotech Experience December 2005 - May 2008
Job Associate DIrector Technical Operations Project Management at ARIAD Pharmaceuticals, Inc.
Industry Biotechnology
Experience
ARIAD Pharmaceuticals, Inc. September 2013 - Present
Synageva BioPharma Corp. January 2013 - June 2013
Synageva BioPharma Corp. April 2012 - January 2013
Stryker Biotech/Olympus Biotech May 2008 - April 2012
Stryker Biotech December 2005 - May 2008
Amgen April 2000 - July 2001
Amgen April 1999 - April 2000
Amgen 1996 - April 1999
Amgen 1995 - 1997
Amgen 1994 - 1995
Skills
Medical Devices, Management, Clinical Research, Cross-functional Team..., Process Improvement, Program Management, Clinical Trials, Biotechnology, Leadership, Regulatory Affairs, Quality Assurance, Supply Chain Management, FDA, Pharmaceutical Industry, Manufacturing, Product Development, Internal Audit, Lifesciences, Project Planning, GMP
Education
Tufts University 1983 — 1989
BS/MS, Chemical Engineering/Biochemical Engineering
The George Washington University 2008 — 2009
Certificate, Heath Care Compliance
ARIAD Pharmaceuticals, Inc. September 2013 - Present
Synageva BioPharma Corp. January 2013 - June 2013
Synageva BioPharma Corp. April 2012 - January 2013
Stryker Biotech/Olympus Biotech May 2008 - April 2012
Stryker Biotech December 2005 - May 2008
Amgen April 2000 - July 2001
Amgen April 1999 - April 2000
Amgen 1996 - April 1999
Amgen 1995 - 1997
Amgen 1994 - 1995
Skills
Medical Devices, Management, Clinical Research, Cross-functional Team..., Process Improvement, Program Management, Clinical Trials, Biotechnology, Leadership, Regulatory Affairs, Quality Assurance, Supply Chain Management, FDA, Pharmaceutical Industry, Manufacturing, Product Development, Internal Audit, Lifesciences, Project Planning, GMP
Education
Tufts University 1983 — 1989
BS/MS, Chemical Engineering/Biochemical Engineering
The George Washington University 2008 — 2009
Certificate, Heath Care Compliance
Gordon (Guozhong) Xu Gordon (Guozhong) Xu's Stryker Biotech Experience July 2007 - February 2012
Job Protein Analytical Scientist
Industry Biotechnology
Experience
Genzyme Corp March 2012 - Present
Stryker Biotech July 2007 - February 2012
CuraGen Corp July 2006 - July 2007
Case Western Reserve University_School of Medicine July 2005 - July 2006
Albert Einstein College of Medicine November 2001 - June 2005
Skills
SDS-PAGE, Light Scattering, Mass Spectrometry, GMP, HPLC (RP, IEX, HIC,..., Protein Characterization, Method Development and..., Analytical Instrument..., Mass Spectrometry..., UV-Vis, CE
Education
Institute of Chemistry, Chinese Academy of Sciences
MS
Peking University, China
BS
The University of Georgia
PhD
Genzyme Corp March 2012 - Present
Stryker Biotech July 2007 - February 2012
CuraGen Corp July 2006 - July 2007
Case Western Reserve University_School of Medicine July 2005 - July 2006
Albert Einstein College of Medicine November 2001 - June 2005
Skills
SDS-PAGE, Light Scattering, Mass Spectrometry, GMP, HPLC (RP, IEX, HIC,..., Protein Characterization, Method Development and..., Analytical Instrument..., Mass Spectrometry..., UV-Vis, CE
Education
Institute of Chemistry, Chinese Academy of Sciences
MS
Peking University, China
BS
The University of Georgia
PhD
Paul Kinsella Paul Kinsella's Stryker Biotech Experience August 2007 - July 2009
Job Assoc. Project Manager at Corrona
Industry Pharmaceuticals
Experience
Corrona February 2015 - Present
CORRONA January 2014 - Present
QA/QS July 2009 - January 2014
Stryker Biotech August 2007 - July 2009
Siemens Healthcare 2007 - 2007
Bayer Diagnostics 1997 - 2007
Serono Labs 1995 - 1997
Skills
Regulatory Affairs, Auditing, ISO 13485, Manufacturing, Leadership, CAPA, Sop, FDA, Quality Management, Quality System, Quality Assurance, Validation, Technology Transfer, Medical Devices, Biotechnology, GMP, Lifesciences, Change Control, GLP, LIMS, Cross-functional Team..., Pharmaceutical Industry, 21 CFR Part 11, Project Management, V&V
Education
Springfield College 1989 — 1993
Bachelor of Science (BS), Biology, General
Corrona February 2015 - Present
CORRONA January 2014 - Present
QA/QS July 2009 - January 2014
Stryker Biotech August 2007 - July 2009
Siemens Healthcare 2007 - 2007
Bayer Diagnostics 1997 - 2007
Serono Labs 1995 - 1997
Skills
Regulatory Affairs, Auditing, ISO 13485, Manufacturing, Leadership, CAPA, Sop, FDA, Quality Management, Quality System, Quality Assurance, Validation, Technology Transfer, Medical Devices, Biotechnology, GMP, Lifesciences, Change Control, GLP, LIMS, Cross-functional Team..., Pharmaceutical Industry, 21 CFR Part 11, Project Management, V&V
Education
Springfield College 1989 — 1993
Bachelor of Science (BS), Biology, General
Buddy Marsh Buddy Marsh's Stryker Biotech Experience September 2003 - January 2011
Job SupervisorPlant Services at Novo Nordisk
Industry Biotechnology
Experience
Novo Nordisk September 2014 - Present
Olympus Biotech America 2013 - 2014
Olympus Biotech America February 2011 - 2013
Stryker Biotech September 2003 - January 2011
Weathervane Seafoods February 1998 - February 2003
Skills
FDA, Biotechnology, Medical Devices, GMP, CAPA, Sop, Validation, Pharmaceutical Industry, V&V, ISO 13485, Lifesciences, Quality System, Biopharmaceuticals, GLP, Technology Transfer, Change Management, Cross-functional Team..., HPLC, Manufacturing, Microbiology, Microsoft Excel, Microsoft Office, Process Improvement, Project Management, Quality Assurance, Team Leadership, Training, Troubleshooting, V, Change Control, Quality Control, Management, 21 CFR Part 11, Aseptic Processing, Laboratory, Continuous Improvement, GxP
Education
State University of New York College of Agriculture and Technology at Cobleskill 1990 — 1992
AS, Landscape development/Forestry
Novo Nordisk September 2014 - Present
Olympus Biotech America 2013 - 2014
Olympus Biotech America February 2011 - 2013
Stryker Biotech September 2003 - January 2011
Weathervane Seafoods February 1998 - February 2003
Skills
FDA, Biotechnology, Medical Devices, GMP, CAPA, Sop, Validation, Pharmaceutical Industry, V&V, ISO 13485, Lifesciences, Quality System, Biopharmaceuticals, GLP, Technology Transfer, Change Management, Cross-functional Team..., HPLC, Manufacturing, Microbiology, Microsoft Excel, Microsoft Office, Process Improvement, Project Management, Quality Assurance, Team Leadership, Training, Troubleshooting, V, Change Control, Quality Control, Management, 21 CFR Part 11, Aseptic Processing, Laboratory, Continuous Improvement, GxP
Education
State University of New York College of Agriculture and Technology at Cobleskill 1990 — 1992
AS, Landscape development/Forestry
Julie Thomason Julie Thomason's Stryker Biotech Experience May 2005 - July 2007
Job Senior Research Associate at Sample6
Industry Research
Experience
Sample6 January 2014 - Present
Sample6 Technologies, Inc. September 2012 - Present
IDEXX Laboratories March 2011 - August 2012
Canaan Conservation Commission January 2008 - August 2012
Enfield Village School January 2010 - March 2011
New Hampshire Rivers Council June 2008 - March 2011
Pioneer Valley Planning Commission January 2009 - May 2009
David's House January 2003 - August 2007
Stryker Biotech May 2005 - July 2007
Stryker Biotech May 2002 - August 2004
Skills
Research, Quality Control, Environmental Monitoring, HPLC, GIS, Materials Management, GPS, Data Management, Microsoft Office, Inventory Management, Spreadsheets, TOC, FTIR, Data Analysis, Quality Assurance, CAPA, GMP, Biotechnology, ArcGIS, Environmental Awareness, Assay Development, Laboratory, UV/Vis, Lifesciences, Life Sciences, Validation
Education
Antioch University New England 2007 — 2009
MS, Resource Management and Conservation
Saint Joseph's College 2001 — 2005
BS, Environmental Science
Kimball Union Academy 1997 — 2001
Sample6 January 2014 - Present
Sample6 Technologies, Inc. September 2012 - Present
IDEXX Laboratories March 2011 - August 2012
Canaan Conservation Commission January 2008 - August 2012
Enfield Village School January 2010 - March 2011
New Hampshire Rivers Council June 2008 - March 2011
Pioneer Valley Planning Commission January 2009 - May 2009
David's House January 2003 - August 2007
Stryker Biotech May 2005 - July 2007
Stryker Biotech May 2002 - August 2004
Skills
Research, Quality Control, Environmental Monitoring, HPLC, GIS, Materials Management, GPS, Data Management, Microsoft Office, Inventory Management, Spreadsheets, TOC, FTIR, Data Analysis, Quality Assurance, CAPA, GMP, Biotechnology, ArcGIS, Environmental Awareness, Assay Development, Laboratory, UV/Vis, Lifesciences, Life Sciences, Validation
Education
Antioch University New England 2007 — 2009
MS, Resource Management and Conservation
Saint Joseph's College 2001 — 2005
BS, Environmental Science
Kimball Union Academy 1997 — 2001
Mike Wollman's Stryker Biotech Experience 1997 - 1998
Job Contract Senior CRA at Pharmacyclics
Industry Pharmaceuticals
Experience
Pharmacyclics June 2015 - Present
Onyx Pharmaceuticals December 2014 - May 2015
Genentech November 2011 - November 2014
Sunesis Pharmaceuticals October 2007 - January 2011
Telik, Inc. 2005 - 2007
Salmedix, Inc. 2004 - 2005
Gilead Sciences 2000 - 2004
Schering-Plough Research Institute 1998 - 2000
Stryker Biotech 1997 - 1998
Cytyc 1996 - 1997
Skills
Clinical Trials, Oncology, CRO, FDA, Clinical Research, Regulatory Submissions, Biotechnology, Sop, Validation, Clinical Study Design, Clinical Development, Drug Development, CTMS, Protocol, Clinical Operations, Clinical Monitoring, GCP, EDC, Therapeutic Areas, SOP
Education
Union College 1990 — 1994
BS, Biology, Psychology
Pharmacyclics June 2015 - Present
Onyx Pharmaceuticals December 2014 - May 2015
Genentech November 2011 - November 2014
Sunesis Pharmaceuticals October 2007 - January 2011
Telik, Inc. 2005 - 2007
Salmedix, Inc. 2004 - 2005
Gilead Sciences 2000 - 2004
Schering-Plough Research Institute 1998 - 2000
Stryker Biotech 1997 - 1998
Cytyc 1996 - 1997
Skills
Clinical Trials, Oncology, CRO, FDA, Clinical Research, Regulatory Submissions, Biotechnology, Sop, Validation, Clinical Study Design, Clinical Development, Drug Development, CTMS, Protocol, Clinical Operations, Clinical Monitoring, GCP, EDC, Therapeutic Areas, SOP
Education
Union College 1990 — 1994
BS, Biology, Psychology
Christopher Boyer's Stryker Biotech Experience May 2004 - January 2008
Job Managing Director at Drake Partners LLC
Industry Medical Devices
Experience
Drake Partners LLC August 2015 - Present
St. Jude Medical August 2014 - August 2015
NeuroTherm, Inc. October 2013 - August 2014
NeuroTherm, Inc. June 2011 - September 2013
NeuroTherm, Inc. April 2010 - June 2011
Smith & Nephew January 2008 - April 2010
Stryker Biotech May 2004 - January 2008
US Army November 2005 - May 2007
US Army May 1999 - May 2004
Skills
Operating Room, Leadership, Cross-functional Team..., Medical Devices, Capital Equipment, Sales & Marketing..., Orthopedic, Product Launch, Surgical Instruments, Market Development, Surgeons, Commercialization, Disposables, Orthopedics, Spine, FDA, Strategic Planning, Setting Strategic..., Sales Growth, Private Equity, Strategic Selling
Education
United States Military Academy at West Point 1995 — 1999
Bachelor’s Degree, Mathematical Sciences, Minor: Mechanical Engineering
Warren-Mott High School, Warren, MI 1991 — 1995
High School
Drake Partners LLC August 2015 - Present
St. Jude Medical August 2014 - August 2015
NeuroTherm, Inc. October 2013 - August 2014
NeuroTherm, Inc. June 2011 - September 2013
NeuroTherm, Inc. April 2010 - June 2011
Smith & Nephew January 2008 - April 2010
Stryker Biotech May 2004 - January 2008
US Army November 2005 - May 2007
US Army May 1999 - May 2004
Skills
Operating Room, Leadership, Cross-functional Team..., Medical Devices, Capital Equipment, Sales & Marketing..., Orthopedic, Product Launch, Surgical Instruments, Market Development, Surgeons, Commercialization, Disposables, Orthopedics, Spine, FDA, Strategic Planning, Setting Strategic..., Sales Growth, Private Equity, Strategic Selling
Education
United States Military Academy at West Point 1995 — 1999
Bachelor’s Degree, Mathematical Sciences, Minor: Mechanical Engineering
Warren-Mott High School, Warren, MI 1991 — 1995
High School
Kevin Downey's Stryker Biotech Experience July 2009 - August 2010
Job Consultant, Scientific & Business Development
Industry Medical Devices
Experience
Connate Consulting November 2012 - Present
aap Implantate AG August 2010 - October 2012
Stryker Biotech July 2009 - August 2010
Stryker Biotech May 2007 - July 2009
Stryker Biotech January 2005 - April 2007
Stryker Biotech August 2003 - January 2005
Stryker Biotech June 2002 - August 2003
Vertex Pharmaceuticals June 2001 - August 2001
Skills
Biotechnology, Medical Devices, R&D, Commercialization, Biologics, Strategy, FDA, Product Development, Pharmaceutical Industry, Product Launch, Marketing, Lifesciences, Marketing Strategy, Surgeons, Global Marketing, Strategic Partnerships, Business Strategy, Project Management, Biomaterials, Bone, Drug Development, New Business Development, Orthopedic, CRO, Technology Transfer, Design Control, Orthopedics, 510 K, Medical Device Product..., Licensing, Market Research, Due Diligence, Stem Cells, International Project..., Intellectual Property, Regulatory Submissions, Tissue Engineering, Cartilage, Spine, Trauma, BMPs, Global Business..., Global Strategy, Technology Evaluation, Cross-functional Team..., Business Development, Corporate Development, Strategic Alliances, Competitive Intelligence, Life Sciences
Education
Saint Michael's College
BS, Biology
Reading Memorial High School
Connate Consulting November 2012 - Present
aap Implantate AG August 2010 - October 2012
Stryker Biotech July 2009 - August 2010
Stryker Biotech May 2007 - July 2009
Stryker Biotech January 2005 - April 2007
Stryker Biotech August 2003 - January 2005
Stryker Biotech June 2002 - August 2003
Vertex Pharmaceuticals June 2001 - August 2001
Skills
Biotechnology, Medical Devices, R&D, Commercialization, Biologics, Strategy, FDA, Product Development, Pharmaceutical Industry, Product Launch, Marketing, Lifesciences, Marketing Strategy, Surgeons, Global Marketing, Strategic Partnerships, Business Strategy, Project Management, Biomaterials, Bone, Drug Development, New Business Development, Orthopedic, CRO, Technology Transfer, Design Control, Orthopedics, 510 K, Medical Device Product..., Licensing, Market Research, Due Diligence, Stem Cells, International Project..., Intellectual Property, Regulatory Submissions, Tissue Engineering, Cartilage, Spine, Trauma, BMPs, Global Business..., Global Strategy, Technology Evaluation, Cross-functional Team..., Business Development, Corporate Development, Strategic Alliances, Competitive Intelligence, Life Sciences
Education
Saint Michael's College
BS, Biology
Reading Memorial High School
Greg Brace, MBA's Stryker Biotech Experience February 2008 - July 2009
Job Licensing Manager at Partners HealthCare
Industry Pharmaceuticals
Experience
Partners HealthCare March 2015 - Present
Johnson & Johnson June 2013 - August 2013
George Washington University October 2012 - May 2013
Genocea Biosciences April 2010 - April 2012
Stryker Biotech February 2008 - July 2009
Formatech Inc. April 2006 - February 2008
Skills
Project Management, Strategy, Project Planning, Data Analysis, Marketing Strategy, Market Research, Process Improvement, Analytical Skills, Business Process..., Customer Segmentation..., CRM, Product Marketing, Analysis, Management, Market Analysis
Education
The George Washington University - School of Business 2012 — 2014
Master of Business Administration (M.B.A.)
Harvard University Extension School 2010 — 2011
Management
University of Massachusetts at Lowell 2006 — 2007
Masters, Biology - Biotechnology
University of Massachusetts Lowell 2003 — 2006
Bachelors, Biology
Partners HealthCare March 2015 - Present
Johnson & Johnson June 2013 - August 2013
George Washington University October 2012 - May 2013
Genocea Biosciences April 2010 - April 2012
Stryker Biotech February 2008 - July 2009
Formatech Inc. April 2006 - February 2008
Skills
Project Management, Strategy, Project Planning, Data Analysis, Marketing Strategy, Market Research, Process Improvement, Analytical Skills, Business Process..., Customer Segmentation..., CRM, Product Marketing, Analysis, Management, Market Analysis
Education
The George Washington University - School of Business 2012 — 2014
Master of Business Administration (M.B.A.)
Harvard University Extension School 2010 — 2011
Management
University of Massachusetts at Lowell 2006 — 2007
Masters, Biology - Biotechnology
University of Massachusetts Lowell 2003 — 2006
Bachelors, Biology
Michele McKay's Stryker Biotech Experience March 1999 - September 2004
Job Senior Quality Engineer at Genzyme
Industry Biotechnology
Experience
Genzyme June 2012 - Present
Genzyme October 2010 - June 2012
Histogenics February 2010 - September 2010
GTC Biotherapeutics October 2004 - November 2009
Stryker Biotech March 1999 - September 2004
Biogen March 1990 - March 1999
Skills
GMP, HPLC, FDA, CAPA, Validation, Biotechnology, Pharmaceutical Industry, Change Control, Biopharmaceuticals, V&V, GLP, Quality Assurance, Sop, Analytical Chemistry, Quality Control, Quality System, Trackwise, Laboratory, Quality Management, GxP, Aseptic Processing, Assay Development, 21 CFR Part 11, Software Documentation, Technology Transfer, SDS-PAGE, LIMS
Education
Worcester Polytechnic Institute 2007 — 2008
Graduate Certificate
Rochester Institute of Technology 1983 — 1987
Bachelor of Science (B.S.)
Genzyme June 2012 - Present
Genzyme October 2010 - June 2012
Histogenics February 2010 - September 2010
GTC Biotherapeutics October 2004 - November 2009
Stryker Biotech March 1999 - September 2004
Biogen March 1990 - March 1999
Skills
GMP, HPLC, FDA, CAPA, Validation, Biotechnology, Pharmaceutical Industry, Change Control, Biopharmaceuticals, V&V, GLP, Quality Assurance, Sop, Analytical Chemistry, Quality Control, Quality System, Trackwise, Laboratory, Quality Management, GxP, Aseptic Processing, Assay Development, 21 CFR Part 11, Software Documentation, Technology Transfer, SDS-PAGE, LIMS
Education
Worcester Polytechnic Institute 2007 — 2008
Graduate Certificate
Rochester Institute of Technology 1983 — 1987
Bachelor of Science (B.S.)
Marcie Goater's Stryker Biotech Experience April 2004 - July 2005
Job Sr. Clincal Affairs Manager at Covidien
Industry Medical Devices
Elizabeth Clare's Stryker Biotech Experience 2002 - 2005
Job Sr Associate at Amgen
Industry Biotechnology
Experience
Amgen February 2011 - Present
Biodirect, Inc. August 2009 - March 2010
Tecan September 2007 - May 2009
Amgen January 2005 - September 2007
Stryker Biotech 2002 - 2005
Skills
Leadership, Biotechnology, Assay Development, ELISA, Management, Troubleshooting, Lifesciences, Technology Transfer, GMP, HPLC, Biopharmaceuticals, Life Sciences
Education
University of Rhode Island 1997 — 2001
Bachelor of Science, Wildlife Management and Biology
Amgen February 2011 - Present
Biodirect, Inc. August 2009 - March 2010
Tecan September 2007 - May 2009
Amgen January 2005 - September 2007
Stryker Biotech 2002 - 2005
Skills
Leadership, Biotechnology, Assay Development, ELISA, Management, Troubleshooting, Lifesciences, Technology Transfer, GMP, HPLC, Biopharmaceuticals, Life Sciences
Education
University of Rhode Island 1997 — 2001
Bachelor of Science, Wildlife Management and Biology
Sarah Martin-Munley's Stryker Biotech Experience December 2009 - February 2010
Job Principal at Sarah MartinMunley, PhD Consulting
Industry Pharmaceuticals
Experience
Sarah Martin-Munley, PhD Consulting July 2011 - Present
Clinipace Worldwide January 2011 - June 2011
Sarah Martin-Munley, PhD Consulting January 2009 - February 2011
Stryker Biotech December 2009 - February 2010
AVEO Pharmaceuticals August 2009 - November 2009
Neurophharm Inc June 2008 - January 2009
Via Cell, Inc. January 2008 - May 2008
AVEO Pharmaceuticals through Halloran Consulting Group October 2007 - February 2008
Molecular Insight Pharmaceuticals through Halloran Consulting Group August 2007 - October 2007
Vertex Pharmaceuticals Inc March 1999 - February 2007
Skills
Oncology, Infectious Diseases, Cardiovascular Disease, Inflammation, Clinical Development, Clinical Trials, CTMS, Biotechnology, Pharmaceutical Industry, Drug Development, CRO, GCP, Clinical Research, EDC, Regulatory Submissions
Education
Skidmore College
BA, Biology and Chemistry (double major)
University of Rochester School of Medicine and Dentistry
PhD, Pharmacology
Sarah Martin-Munley, PhD Consulting July 2011 - Present
Clinipace Worldwide January 2011 - June 2011
Sarah Martin-Munley, PhD Consulting January 2009 - February 2011
Stryker Biotech December 2009 - February 2010
AVEO Pharmaceuticals August 2009 - November 2009
Neurophharm Inc June 2008 - January 2009
Via Cell, Inc. January 2008 - May 2008
AVEO Pharmaceuticals through Halloran Consulting Group October 2007 - February 2008
Molecular Insight Pharmaceuticals through Halloran Consulting Group August 2007 - October 2007
Vertex Pharmaceuticals Inc March 1999 - February 2007
Skills
Oncology, Infectious Diseases, Cardiovascular Disease, Inflammation, Clinical Development, Clinical Trials, CTMS, Biotechnology, Pharmaceutical Industry, Drug Development, CRO, GCP, Clinical Research, EDC, Regulatory Submissions
Education
Skidmore College
BA, Biology and Chemistry (double major)
University of Rochester School of Medicine and Dentistry
PhD, Pharmacology
Julie (Julieta) Sousa's Stryker Biotech Experience May 2005 - July 2007
Job
Industry Pharmaceuticals
Experience
Allergan January 2014 - Present
ImmunoGen, Inc. October 2012 - January 2014
Advanced Technologies and Regenerative Medicine July 2007 - June 2012
Stryker Biotech May 2005 - July 2007
Amgen October 2003 - May 2005
Acambis February 2003 - September 2003
Stryker Biotech September 1999 - January 2003
Hybridon September 1998 - September 1999
Serono Labs August 1992 - 1998
Skills
Quality Control..., Stability managment, Method Development, HPLC, CE, SDS-PAGE, Western Blotting, IEF, BIOASSAY, CELL CULTURE, Data Review / Approval, OOS investigations, GMP, Cell Culture, Quality Assurance, Medical Devices, Chemistry, Laboratory, Bioassay, Protein Chemistry, CAPA, GLP, ELISA, LIMS, Biopharmaceuticals, FDA, Immunoassays, Quality Control
Education
University of Massachusetts Dartmouth 1985 — 1989
BS, Biology
Allergan January 2014 - Present
ImmunoGen, Inc. October 2012 - January 2014
Advanced Technologies and Regenerative Medicine July 2007 - June 2012
Stryker Biotech May 2005 - July 2007
Amgen October 2003 - May 2005
Acambis February 2003 - September 2003
Stryker Biotech September 1999 - January 2003
Hybridon September 1998 - September 1999
Serono Labs August 1992 - 1998
Skills
Quality Control..., Stability managment, Method Development, HPLC, CE, SDS-PAGE, Western Blotting, IEF, BIOASSAY, CELL CULTURE, Data Review / Approval, OOS investigations, GMP, Cell Culture, Quality Assurance, Medical Devices, Chemistry, Laboratory, Bioassay, Protein Chemistry, CAPA, GLP, ELISA, LIMS, Biopharmaceuticals, FDA, Immunoassays, Quality Control
Education
University of Massachusetts Dartmouth 1985 — 1989
BS, Biology
Rebecca Maul's Stryker Biotech Experience February 2001 - July 2009
Job Executive Administrative Assistant Finance
Industry Information Technology and Services
Experience
PTC October 2011 - Present
Biogen Idec February 2010 - May 2011
Veritude / Biogen Idec December 2009 - February 2010
Stryker Biotech February 2001 - July 2009
Skills
Visio, Access, Microsoft Office, Payroll, Office Equipment, Oracle, Expense Reports, Outlook, Administrative..., Lotus Notes, Software Documentation, Expenses, Travel Arrangements, Human Resources, Microsoft Excel, Calendars, Office Administration, Spreadsheets, Microsoft Word, PowerPoint, Accounts Receivable, Office Management, Leadership, Quality Assurance, Management, Cross-functional Team..., Time Management, Budgets, Training, Accounting, Project Management, Employee Training, Auditing, Sales, Administrative Work, Employee Benefits, Policy, General Ledger, Accounts Payable, Process Scheduler, Data Entry, Process Improvement
Education
University of Phoenix 2006 — 2010
Bachelor of Science (B.S.), Business / Finance
PTC October 2011 - Present
Biogen Idec February 2010 - May 2011
Veritude / Biogen Idec December 2009 - February 2010
Stryker Biotech February 2001 - July 2009
Skills
Visio, Access, Microsoft Office, Payroll, Office Equipment, Oracle, Expense Reports, Outlook, Administrative..., Lotus Notes, Software Documentation, Expenses, Travel Arrangements, Human Resources, Microsoft Excel, Calendars, Office Administration, Spreadsheets, Microsoft Word, PowerPoint, Accounts Receivable, Office Management, Leadership, Quality Assurance, Management, Cross-functional Team..., Time Management, Budgets, Training, Accounting, Project Management, Employee Training, Auditing, Sales, Administrative Work, Employee Benefits, Policy, General Ledger, Accounts Payable, Process Scheduler, Data Entry, Process Improvement
Education
University of Phoenix 2006 — 2010
Bachelor of Science (B.S.), Business / Finance
James M. Naze's Stryker Biotech Experience October 2008 - December 2009
Job Packaging Engineer II at Boston Scientific
Industry Pharmaceuticals
Experience
Boston Scientific December 2009 - Present
Stryker Biotech October 2008 - December 2009
Osram Sylvania May 1998 - September 2008
UCB (fka Medeva Pharmaceuticals) 1996 - 1998
Meridian technology Group 1992 - 1996
Skills
Packaging, AutoCAD, Packaging Engineering, ArtiosCAD
Education
Rochester Institute of Technology 1993 — 1998
Packaging Science
State University of New York College at Oswego 1986 — 1990
Boston Scientific December 2009 - Present
Stryker Biotech October 2008 - December 2009
Osram Sylvania May 1998 - September 2008
UCB (fka Medeva Pharmaceuticals) 1996 - 1998
Meridian technology Group 1992 - 1996
Skills
Packaging, AutoCAD, Packaging Engineering, ArtiosCAD
Education
Rochester Institute of Technology 1993 — 1998
Packaging Science
State University of New York College at Oswego 1986 — 1990
Bethany Hendrickson (Gobeille)'s Stryker Biotech Experience August 2005 - August 2006
Job QA Product Assurance Manager at CVS Health
Industry Pharmaceuticals
Experience
CVS Health March 2015 - Present
UL June 2013 - March 2015
Privately Held Company February 2008 - June 2013
Amgen August 2006 - October 2007
Stryker Biotech August 2005 - August 2006
Shuster Laboratories July 2001 - August 2005
Skills
CAPA, Validation, LIMS, Process Validation, cGMP, GMP, GLP, GDP, SOP
Education
Mary Washington College 1997 — 2001
BS, Biology
CVS Health March 2015 - Present
UL June 2013 - March 2015
Privately Held Company February 2008 - June 2013
Amgen August 2006 - October 2007
Stryker Biotech August 2005 - August 2006
Shuster Laboratories July 2001 - August 2005
Skills
CAPA, Validation, LIMS, Process Validation, cGMP, GMP, GLP, GDP, SOP
Education
Mary Washington College 1997 — 2001
BS, Biology
Matthew Simeone's Stryker Biotech Experience January 2003 - December 2005
Job Supervisor of Plant Operations at Providence Water Supply Board
Industry Utilities
Experience
Providence Water Supply Board June 2010 - Present
Pare Corporation January 2008 - August 2009
Amgen February 2006 - October 2007
Stryker Biotech January 2003 - December 2005
Skills
Process Engineering, Environmental Awareness, Wastewater Treatment, Chemical Engineering, Project Planning, Root Cause Analysis
Education
University of Rhode Island 1986 — 1991
Chemical Engineering
Providence Water Supply Board June 2010 - Present
Pare Corporation January 2008 - August 2009
Amgen February 2006 - October 2007
Stryker Biotech January 2003 - December 2005
Skills
Process Engineering, Environmental Awareness, Wastewater Treatment, Chemical Engineering, Project Planning, Root Cause Analysis
Education
University of Rhode Island 1986 — 1991
Chemical Engineering
Jill Harrington's Stryker Biotech Experience July 2010 - March 2011
Job Principal Consultant at BioBridges
Industry Biotechnology
Experience
BioBridges June 2015 - Present
Cubist Pharmaceuticals June 2013 - May 2015
Cubist Pharmaceuticals December 2012 - June 2013
Stryker Biotech July 2010 - March 2011
Stryker Biotech March 2010 - July 2010
Lantheus Medical Imaging February 2009 - February 2010
BioVex, Inc. June 2008 - January 2009
ArQule November 2007 - June 2008
Outcome 2007 - 2007
Quintiles 1998 - 2000
Education
Tufts University 1989 — 1993
Bachelor’s Degree, Psychology
Boston Latin School 1983 — 1989
BioBridges June 2015 - Present
Cubist Pharmaceuticals June 2013 - May 2015
Cubist Pharmaceuticals December 2012 - June 2013
Stryker Biotech July 2010 - March 2011
Stryker Biotech March 2010 - July 2010
Lantheus Medical Imaging February 2009 - February 2010
BioVex, Inc. June 2008 - January 2009
ArQule November 2007 - June 2008
Outcome 2007 - 2007
Quintiles 1998 - 2000
Education
Tufts University 1989 — 1993
Bachelor’s Degree, Psychology
Boston Latin School 1983 — 1989
David Malliaros's Stryker Biotech Experience June 2007 - April 2010
Job Director, Analytical Technical Operations at Ironwood Pharmaceuticals
Industry Biotechnology
Experience
Ironwood Pharmaceuticals January 2013 - Present
Olympus Biotech (formerly Stryker Biotech) April 2010 - January 2013
Stryker Biotech June 2007 - April 2010
Biogen Idec 2002 - 2007
BioTransplant 2001 - 2002
Massachusetts Biologics Laboratories 1998 - 2001
Chiron Corporation 1993 - 1998
Harvard University 1988 - 1991
University of Massachuestts, Lowell 1983 - 1988
Skills
Protein Chemistry, Analytical Chemistry, Medical Devices, QC, Quality Assurance, Biotechnology, Biochemistry, Vaccines, Pharmaceuticals, cGMP, GLP, CAPA, FDA, HPLC, Validation, Immunoassays, Troubleshooting, GMP, IND, Regulatory Submissions, Change Control, Biopharmaceuticals, Sop, 21 CFR Part 11, V&V, ISO 13485, Pharmaceutical Industry, Quality Control, Technology Transfer, LIMS, Chemistry, Assay Development, Purification, Aseptic Processing, GxP, Cleaning Validation, Chromatography, Drug Development, ELISA, Regulatory Affairs, Lifesciences, Department Budgeting, SOP, Life Sciences
Education
University of Massachusetts Lowell 1983 — 1988
Ph.D., Biochemistry
University of Massachusetts, Amherst 1973 — 1977
BS, Zoology
Ironwood Pharmaceuticals January 2013 - Present
Olympus Biotech (formerly Stryker Biotech) April 2010 - January 2013
Stryker Biotech June 2007 - April 2010
Biogen Idec 2002 - 2007
BioTransplant 2001 - 2002
Massachusetts Biologics Laboratories 1998 - 2001
Chiron Corporation 1993 - 1998
Harvard University 1988 - 1991
University of Massachuestts, Lowell 1983 - 1988
Skills
Protein Chemistry, Analytical Chemistry, Medical Devices, QC, Quality Assurance, Biotechnology, Biochemistry, Vaccines, Pharmaceuticals, cGMP, GLP, CAPA, FDA, HPLC, Validation, Immunoassays, Troubleshooting, GMP, IND, Regulatory Submissions, Change Control, Biopharmaceuticals, Sop, 21 CFR Part 11, V&V, ISO 13485, Pharmaceutical Industry, Quality Control, Technology Transfer, LIMS, Chemistry, Assay Development, Purification, Aseptic Processing, GxP, Cleaning Validation, Chromatography, Drug Development, ELISA, Regulatory Affairs, Lifesciences, Department Budgeting, SOP, Life Sciences
Education
University of Massachusetts Lowell 1983 — 1988
Ph.D., Biochemistry
University of Massachusetts, Amherst 1973 — 1977
BS, Zoology
Tracy Landeryou's Stryker Biotech Experience 1999 - 2004
Job Director, QC Microbiology, Pfizer
Industry Biotechnology
Experience
Pfizer June 2004 - Present
Stryker Biotech 1999 - 2004
AstraZeneca April 1999 - October 1999
Seragen 1994 - 1999
Alkermes 1992 - 1994
Education
Temple University 2006 — 2010
M.S., Quality Assurance/Regulatory Affairs
University of Maine 1985 — 1990
Pfizer June 2004 - Present
Stryker Biotech 1999 - 2004
AstraZeneca April 1999 - October 1999
Seragen 1994 - 1999
Alkermes 1992 - 1994
Education
Temple University 2006 — 2010
M.S., Quality Assurance/Regulatory Affairs
University of Maine 1985 — 1990
Cynthia Winters's Stryker Biotech Experience November 1997 - October 2005
Job TPO, Inc.; Winters Management Consulting, LLC
Industry Human Resources
Experience
TPO, Inc. January 2009 - Present
Winters Management Consulting, LLC May 2006 - Present
Stryker Biotech November 1997 - October 2005
Creative BioMolecules June 1995 - November 1997
Skills
Employee Relations, Strategic HR, Talent Management, Policy, Leadership Development, Human Resources, Organizational..., Performance Management, Deferred Compensation, HRIS, Onboarding, Succession Planning, Recruiting, Workforce Planning, Personnel Management, Employee Benefits, Coaching, Talent Acquisition, Benefits Administration, Executive Coaching, Employment Law, Change Management, Employee Engagement, Organizational..., Interviews, HR Policies, Career Development, Job Descriptions, HR Consulting, Technical Recruiting, Applicant Tracking..., Resume Writing, Employee Training, Employee Handbooks, Hiring, Leadership, Executive Pay, Organizational Design, Career Management, Legal Compliance, Labor Relations, College Recruiting, New Hire Orientations, Temporary Placement, Training, FMLA, Executive Search, Benefits Negotiation, Strategy, Management
Education
Hartford College for Women
A.A., Psychology
The Johns Hopkins University
M.S,, Adult & Continuing Education
University of New Hampshire
B.A., Psychology & Sociology
TPO, Inc. January 2009 - Present
Winters Management Consulting, LLC May 2006 - Present
Stryker Biotech November 1997 - October 2005
Creative BioMolecules June 1995 - November 1997
Skills
Employee Relations, Strategic HR, Talent Management, Policy, Leadership Development, Human Resources, Organizational..., Performance Management, Deferred Compensation, HRIS, Onboarding, Succession Planning, Recruiting, Workforce Planning, Personnel Management, Employee Benefits, Coaching, Talent Acquisition, Benefits Administration, Executive Coaching, Employment Law, Change Management, Employee Engagement, Organizational..., Interviews, HR Policies, Career Development, Job Descriptions, HR Consulting, Technical Recruiting, Applicant Tracking..., Resume Writing, Employee Training, Employee Handbooks, Hiring, Leadership, Executive Pay, Organizational Design, Career Management, Legal Compliance, Labor Relations, College Recruiting, New Hire Orientations, Temporary Placement, Training, FMLA, Executive Search, Benefits Negotiation, Strategy, Management
Education
Hartford College for Women
A.A., Psychology
The Johns Hopkins University
M.S,, Adult & Continuing Education
University of New Hampshire
B.A., Psychology & Sociology
Naseem Kabir's Stryker Biotech Experience May 2000 - March 2001
Job Director, Global Regulatory Affairs (Japan Asia Pacific) at Amgen, Inc.
Industry Biotechnology
Experience
Amgen, Inc. August 2015 - Present
Amgen November 2014 - Present
Amgen June 2013 - November 2014
Genzyme, a Sanofi Company January 2010 - May 2013
Genzyme Corporation January 2009 - March 2010
Genzyme Corporation April 2008 - December 2008
Genzyme Corporation April 2002 - March 2008
Genzyme Corporation April 2001 - April 2002
Stryker Biotech May 2000 - March 2001
Genzyme Corporation March 1999 - May 2000
Skills
Regulatory Affairs, FDA, Biotechnology, Clinical Trials, Pharmaceuticals, Clinical Research, Oncology, Life Sciences, International..., Emerging Markets, Lifesciences, Pharmaceutical Industry, Quality System, Validation, Sop, Clinical Development, IND, Regulatory Requirements, GLP, Medical Devices, SOP
Education
University of Madras 1984 — 1986
Master of Science (M.S.), Zoology/Animal Biology
Amgen, Inc. August 2015 - Present
Amgen November 2014 - Present
Amgen June 2013 - November 2014
Genzyme, a Sanofi Company January 2010 - May 2013
Genzyme Corporation January 2009 - March 2010
Genzyme Corporation April 2008 - December 2008
Genzyme Corporation April 2002 - March 2008
Genzyme Corporation April 2001 - April 2002
Stryker Biotech May 2000 - March 2001
Genzyme Corporation March 1999 - May 2000
Skills
Regulatory Affairs, FDA, Biotechnology, Clinical Trials, Pharmaceuticals, Clinical Research, Oncology, Life Sciences, International..., Emerging Markets, Lifesciences, Pharmaceutical Industry, Quality System, Validation, Sop, Clinical Development, IND, Regulatory Requirements, GLP, Medical Devices, SOP
Education
University of Madras 1984 — 1986
Master of Science (M.S.), Zoology/Animal Biology
Justin Alexander, PMP's Stryker Biotech Experience February 2006 - October 2008
Job Sr. Manager Project Management and cLEAN
Industry Biotechnology
Experience
Novo Nordisk September 2014 - Present
Olympus Biotech February 2012 - August 2014
Olympus Biotech October 2008 - February 2012
Stryker Biotech February 2006 - October 2008
Pfizer Pharmaceuticals February 2002 - February 2006
Pfizer Pharmaceuticals July 1999 - February 2002
Skills
Lean Manufacturing, Technology Transfer, Root Cause Analysis, Operational Excellence, Process Engineering, cGMP, PMP, Project Management, Project Portfolio..., Manufacturing, GMP, Process Improvement, Validation, Continuous Improvement, Six Sigma, Medical Devices, Biopharmaceuticals, Cross-functional Team...
Education
University of New Haven 2002 — 2004
MS, Engineering Management
University of Rochester 1995 — 1999
BS, Chemical Engineering
Novo Nordisk September 2014 - Present
Olympus Biotech February 2012 - August 2014
Olympus Biotech October 2008 - February 2012
Stryker Biotech February 2006 - October 2008
Pfizer Pharmaceuticals February 2002 - February 2006
Pfizer Pharmaceuticals July 1999 - February 2002
Skills
Lean Manufacturing, Technology Transfer, Root Cause Analysis, Operational Excellence, Process Engineering, cGMP, PMP, Project Management, Project Portfolio..., Manufacturing, GMP, Process Improvement, Validation, Continuous Improvement, Six Sigma, Medical Devices, Biopharmaceuticals, Cross-functional Team...
Education
University of New Haven 2002 — 2004
MS, Engineering Management
University of Rochester 1995 — 1999
BS, Chemical Engineering
Sheila Lopez's Stryker Biotech Experience November 2004 - December 2008
Job Neurovascular Sales Representative at Johnson & Johnson Codman
Industry Hospital & Health Care
Experience
Johnson & Johnson Codman August 2012 - Present
Medtronic Spine & Biologics December 2010 - June 2012
Progressive Spine December 2008 - December 2010
Stryker Biotech November 2004 - December 2008
Medtronic February 2003 - November 2004
Johnson & Johnson September 1996 - January 2003
Skills
Orthopedic, Surgeons, Spine, Neurology, Clinical Research, Sales, Negotiation, Management, Operating Room, Medical Devices, Capital Equipment, Surgical Instruments, Surgery, Disposables, General Surgery, Hospitals, ENT, Cardiology, Interventional..., Market Development, Neurosurgery, Sales Operations, Wound Care, Biologics, Medical Sales, Diabetes, Endocrinology, Vascular, Selling Skills
Education
The Ohio State University 1985 — 1990
BA, Journalism, Public Relations Marketing minor
Johnson & Johnson Codman August 2012 - Present
Medtronic Spine & Biologics December 2010 - June 2012
Progressive Spine December 2008 - December 2010
Stryker Biotech November 2004 - December 2008
Medtronic February 2003 - November 2004
Johnson & Johnson September 1996 - January 2003
Skills
Orthopedic, Surgeons, Spine, Neurology, Clinical Research, Sales, Negotiation, Management, Operating Room, Medical Devices, Capital Equipment, Surgical Instruments, Surgery, Disposables, General Surgery, Hospitals, ENT, Cardiology, Interventional..., Market Development, Neurosurgery, Sales Operations, Wound Care, Biologics, Medical Sales, Diabetes, Endocrinology, Vascular, Selling Skills
Education
The Ohio State University 1985 — 1990
BA, Journalism, Public Relations Marketing minor
Jason Trussell's Stryker Biotech Experience July 2006 - December 2008
Job Senior Manager, Manufacturing Engineering and Validation at Novo Nordisk
Industry Biotechnology
Experience
Novo Nordisk September 2014 - Present
Olympus Biotech America January 2013 - August 2014
Olympus Biotech America January 2009 - March 2013
Stryker Biotech July 2006 - December 2008
Stryker Biotech February 2004 - June 2006
Monsanto March 2001 - October 2003
Monsanto Company April 2000 - February 2001
Monsanto Company July 1999 - April 2000
Monsanto Company August 1997 - July 1999
State of Missouri, Department of Natural Resources, Air Pollution Control Program June 1996 - August 1997
Skills
Mammalian Cell Culture, Process Engineering, Biopharmaceuticals, GMP, GAMP, Technology Transfer, Validation, Quality System, Project Management, Aseptic Processing, Purification, Biotechnology, 21 CFR Part 11, Manufacturing, Root Cause Analysis, R&D, FDA, Cross-functional Team..., Computer System..., Troubleshooting, Quality Assurance, Change Control, Lifesciences, Cell Culture, Process Improvement, Cleaning Validation, Pharmaceutical Industry, Biochemistry, Formulation, Protein Purification, Materials Science, CAPA
Education
University of Missouri-Rolla 1991 — 1996
BS, Chemical Engineering
Novo Nordisk September 2014 - Present
Olympus Biotech America January 2013 - August 2014
Olympus Biotech America January 2009 - March 2013
Stryker Biotech July 2006 - December 2008
Stryker Biotech February 2004 - June 2006
Monsanto March 2001 - October 2003
Monsanto Company April 2000 - February 2001
Monsanto Company July 1999 - April 2000
Monsanto Company August 1997 - July 1999
State of Missouri, Department of Natural Resources, Air Pollution Control Program June 1996 - August 1997
Skills
Mammalian Cell Culture, Process Engineering, Biopharmaceuticals, GMP, GAMP, Technology Transfer, Validation, Quality System, Project Management, Aseptic Processing, Purification, Biotechnology, 21 CFR Part 11, Manufacturing, Root Cause Analysis, R&D, FDA, Cross-functional Team..., Computer System..., Troubleshooting, Quality Assurance, Change Control, Lifesciences, Cell Culture, Process Improvement, Cleaning Validation, Pharmaceutical Industry, Biochemistry, Formulation, Protein Purification, Materials Science, CAPA
Education
University of Missouri-Rolla 1991 — 1996
BS, Chemical Engineering
Rachdat Toubia's Stryker Biotech Experience August 2003 - May 2006
Job Technical QA Lead, QA Operations at BristolMyers Squibb
Industry Pharmaceuticals
Experience
Bristol-Myers Squibb August 2011 - Present
Lonza Biologics Inc. October 2008 - July 2011
Johnson Matthey Pharma Services May 2006 - October 2008
Stryker Biotech August 2003 - May 2006
Biotransplant Inc. May 1999 - June 2002
Skills
Validation, Quality Assurance, Biotechnology, Quality System, Sop, GMP, FDA, Manufacturing, CAPA, Medical Devices, ISO, 21 CFR Part 11, Change Control, Aseptic Processing, Computer System..., V&V, GLP, Biopharmaceuticals, LIMS, GxP
Education
University of Massachusetts Lowell 1995 — 1998
Bachelor's, Biology
Bristol-Myers Squibb August 2011 - Present
Lonza Biologics Inc. October 2008 - July 2011
Johnson Matthey Pharma Services May 2006 - October 2008
Stryker Biotech August 2003 - May 2006
Biotransplant Inc. May 1999 - June 2002
Skills
Validation, Quality Assurance, Biotechnology, Quality System, Sop, GMP, FDA, Manufacturing, CAPA, Medical Devices, ISO, 21 CFR Part 11, Change Control, Aseptic Processing, Computer System..., V&V, GLP, Biopharmaceuticals, LIMS, GxP
Education
University of Massachusetts Lowell 1995 — 1998
Bachelor's, Biology
Todd Banas's Stryker Biotech Experience July 2009 - October 2011
Job Director of Technical and Manufacturing Services at Alexion Pharmaceuticals
Industry Biotechnology
Experience
Alexion Pharmaceuticals January 2012 - Present
Stryker Biotech July 2009 - October 2011
Stryker Biotech June 2003 - February 2009
Stryker Biotech June 2000 - February 2003
Creative BioMolecules, Inc 1993 - 2000
Skills
Biotechnology, FDA, GLP, Technology Transfer, Biopharmaceuticals, Lifesciences, Sop, SDS-PAGE, ELISA
Education
University of New Hampshire 1986 — 1991
MS, BioScience and Technology
Alexion Pharmaceuticals January 2012 - Present
Stryker Biotech July 2009 - October 2011
Stryker Biotech June 2003 - February 2009
Stryker Biotech June 2000 - February 2003
Creative BioMolecules, Inc 1993 - 2000
Skills
Biotechnology, FDA, GLP, Technology Transfer, Biopharmaceuticals, Lifesciences, Sop, SDS-PAGE, ELISA
Education
University of New Hampshire 1986 — 1991
MS, BioScience and Technology
David Malliaros's Stryker Biotech Experience June 2007 - April 2010
Job Director, Analytical Technical Operations at Ironwood Pharmaceuticals
Industry Biotechnology
Experience
Ironwood Pharmaceuticals January 2013 - Present
Olympus Biotech (formerly Stryker Biotech) April 2010 - January 2013
Stryker Biotech June 2007 - April 2010
Biogen Idec October 2002 - June 2007
Skills
Oversee 26 staff..., Technical Leadership, Purification, Validation, GLP, Quality System, FDA, Quality Control, Quality Assurance, HPLC, Biochemistry, Protein Chemistry, Biotechnology, ISO 13485, Assay Development, Lifesciences, 21 CFR Part 11, LIMS, GMP, CAPA, Biopharmaceuticals, Sop, Medical Devices, Change Control
Education
University of Massachusetts at Lowell 1983 — 1988
Ph.D., Biochemistry
University of Massachusetts, Amherst 1973 — 1977
BS, Zoology
Ironwood Pharmaceuticals January 2013 - Present
Olympus Biotech (formerly Stryker Biotech) April 2010 - January 2013
Stryker Biotech June 2007 - April 2010
Biogen Idec October 2002 - June 2007
Skills
Oversee 26 staff..., Technical Leadership, Purification, Validation, GLP, Quality System, FDA, Quality Control, Quality Assurance, HPLC, Biochemistry, Protein Chemistry, Biotechnology, ISO 13485, Assay Development, Lifesciences, 21 CFR Part 11, LIMS, GMP, CAPA, Biopharmaceuticals, Sop, Medical Devices, Change Control
Education
University of Massachusetts at Lowell 1983 — 1988
Ph.D., Biochemistry
University of Massachusetts, Amherst 1973 — 1977
BS, Zoology
David LeProhon's Stryker Biotech Experience November 2009 - March 2010
Job Principal Consultant at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL September 2012 - Present
Bristol-Myers Squibb, Devens April 2011 - November 2012
Vertex Pharmaceuticals May 2010 - March 2011
Stryker Biotech November 2009 - March 2010
Stryker Biotech September 2004 - January 2010
Biogen March 2002 - September 2004
Biogen April 2001 - March 2002
Biogen May 1998 - April 2001
Biogen December 1992 - May 1998
Army National Guard June 1988 - July 1995
Skills
Validation, CAPA, Quality System, Quality Assurance, GLP, Pharmaceutical Industry, Change Control, Medical Devices, Quality Control, Manufacturing, Clinical Trials, Product Development
Education
Southern New Hampshire University 1995 — 2002
MBA, Business
University of Massachusetts, Amherst 1988 — 1990
BS, Biochemistry
PAREXEL September 2012 - Present
Bristol-Myers Squibb, Devens April 2011 - November 2012
Vertex Pharmaceuticals May 2010 - March 2011
Stryker Biotech November 2009 - March 2010
Stryker Biotech September 2004 - January 2010
Biogen March 2002 - September 2004
Biogen April 2001 - March 2002
Biogen May 1998 - April 2001
Biogen December 1992 - May 1998
Army National Guard June 1988 - July 1995
Skills
Validation, CAPA, Quality System, Quality Assurance, GLP, Pharmaceutical Industry, Change Control, Medical Devices, Quality Control, Manufacturing, Clinical Trials, Product Development
Education
Southern New Hampshire University 1995 — 2002
MBA, Business
University of Massachusetts, Amherst 1988 — 1990
BS, Biochemistry
Cindy Crosby's Stryker Biotech Experience 1991 - 1996
Job VP Customer Logistic Services and Market Quality at Johnson & Johnson
Industry Hospital & Health Care
Experience
Johnson & Johnson September 2010 - Present
Johnson & Johnson July 2008 - September 2010
Ethicon 2005 - 2008
Ethicon 2004 - 2005
Hill-Rom 2000 - 2004
PLC Medical Systems 1997 - 2000
NMT Medical 1997 - 1997
Stryker Biotech 1991 - 1996
Skills
Combination Products, Biologics, Medical Devices, Regulatory Affairs, Quality System, Health Authority..., CAPA, Change Control, FDA, Quality Assurance, Regulatory Submissions, ISO 14971, ISO 13485, Design Control, V&V, Pharmaceutical Industry, GMP, Leadership, Strategy, Regulations, Validation, 21 CFR Part 11, Strategic Planning, Computer System..., GxP, Organizational..., Executive Coaching, Executive Management
Education
Suffolk University
Johnson & Johnson September 2010 - Present
Johnson & Johnson July 2008 - September 2010
Ethicon 2005 - 2008
Ethicon 2004 - 2005
Hill-Rom 2000 - 2004
PLC Medical Systems 1997 - 2000
NMT Medical 1997 - 1997
Stryker Biotech 1991 - 1996
Skills
Combination Products, Biologics, Medical Devices, Regulatory Affairs, Quality System, Health Authority..., CAPA, Change Control, FDA, Quality Assurance, Regulatory Submissions, ISO 14971, ISO 13485, Design Control, V&V, Pharmaceutical Industry, GMP, Leadership, Strategy, Regulations, Validation, 21 CFR Part 11, Strategic Planning, Computer System..., GxP, Organizational..., Executive Coaching, Executive Management
Education
Suffolk University
Kathleen Gula Mitchell's Stryker Biotech Experience December 2007 - February 2011
Job Sr. Manager, CMC at Alexion Pharmaceuticals, Inc.
Industry Biotechnology
Experience
Alexion Pharmaceuticals, Inc. January 2015 - Present
Alexion Pharmaceuticals January 2012 - Present
Olympus Biotech February 2011 - January 2012
Stryker Biotech December 2007 - February 2011
Stryker Biotech October 2006 - December 2007
Stryker Biotech May 2005 - October 2006
AstraZeneca December 2001 - May 2005
Education
University of Rhode Island - College of Business Administration 2008 — 2010
MBA
University of Rhode Island 2007 — 2009
Masters, Biotechnology
Villanova University 1997 — 2001
Bachelors, Chemical Engineering
Alexion Pharmaceuticals, Inc. January 2015 - Present
Alexion Pharmaceuticals January 2012 - Present
Olympus Biotech February 2011 - January 2012
Stryker Biotech December 2007 - February 2011
Stryker Biotech October 2006 - December 2007
Stryker Biotech May 2005 - October 2006
AstraZeneca December 2001 - May 2005
Education
University of Rhode Island - College of Business Administration 2008 — 2010
MBA
University of Rhode Island 2007 — 2009
Masters, Biotechnology
Villanova University 1997 — 2001
Bachelors, Chemical Engineering
Martha Larence's Stryker Biotech Experience Quality Assurance SpecialistAbbott Bioresearch Center2000 - 2003
Job Quality Assurance Associate III at Stryker Biotech
Industry Biotechnology
Experience
Stryker Biotech Quality Assurance SpecialistAbbott Bioresearch Center2000 - 2003
Education
University of Rhode Island 1991 — 1993
BS, Microbiology
Stryker Biotech Quality Assurance SpecialistAbbott Bioresearch Center2000 - 2003
Education
University of Rhode Island 1991 — 1993
BS, Microbiology
David Susco, PE's Stryker Biotech Experience 2008 - 2011
Job Senior Facilities Engineer at Novo Nordisk
Industry Biotechnology
Experience
Novo Nordisk 2014 - Present
Olympus Biotech (Formerly Stryker Biotech) 2011 - 2014
Stryker Biotech 2008 - 2011
Schering-Plough (purchased by Merck) 2002 - 2008
Perigon International, Inc. 1992 - 2002
Dowell Schlumberger 1991 - 1992
Skills
Cross-functional Team..., Validation, FDA, Root Cause Analysis, Medical Devices, Quality System, Change Control, Biotechnology, GMP, CAPA, Manufacturing, Process Engineering, Pharmaceutical Industry, 21 CFR Part 11, GAMP, Quality Management, Quality Assurance, Lean Manufacturing, Process Improvement, Project Management, Facilities Management, Engineering, Change Management, ISO 13485, Department Budgeting, Consultant, FAT's / SAT's, Start-ups, Construction Management, Supervisory Experience, Mechanical Engineering, Troubleshooting, Plant Maintenance, Preventive Maintenance, Cryogenics, Decommissioning, Shutdowns, ACAD, Piping and..., SOP development, HVAC, Clean Utilities, OSHA, Fall Protection, LOTO, First Aid, Pressure Vessel Design, Machine Design, Microsoft Office
Education
University of North Carolina at Charlotte 1985 — 1991
BSME, Mechanical Engineering
Novo Nordisk 2014 - Present
Olympus Biotech (Formerly Stryker Biotech) 2011 - 2014
Stryker Biotech 2008 - 2011
Schering-Plough (purchased by Merck) 2002 - 2008
Perigon International, Inc. 1992 - 2002
Dowell Schlumberger 1991 - 1992
Skills
Cross-functional Team..., Validation, FDA, Root Cause Analysis, Medical Devices, Quality System, Change Control, Biotechnology, GMP, CAPA, Manufacturing, Process Engineering, Pharmaceutical Industry, 21 CFR Part 11, GAMP, Quality Management, Quality Assurance, Lean Manufacturing, Process Improvement, Project Management, Facilities Management, Engineering, Change Management, ISO 13485, Department Budgeting, Consultant, FAT's / SAT's, Start-ups, Construction Management, Supervisory Experience, Mechanical Engineering, Troubleshooting, Plant Maintenance, Preventive Maintenance, Cryogenics, Decommissioning, Shutdowns, ACAD, Piping and..., SOP development, HVAC, Clean Utilities, OSHA, Fall Protection, LOTO, First Aid, Pressure Vessel Design, Machine Design, Microsoft Office
Education
University of North Carolina at Charlotte 1985 — 1991
BSME, Mechanical Engineering
Judith Sernatinger's Stryker Biotech Experience April 2004 - December 2009
Job Vice President Corporate Quality and Compliance at Alexion Pharmaceuticals, Inc.
Industry Biotechnology
Experience
Alexion Pharmaceuticals, Inc. September 2014 - Present
Stryker November 2009 - September 2014
Stryker Biotech April 2004 - December 2009
Biogen November 1996 - April 2004
genentech 1988 - 1996
Skills
FDA, GMP, Quality System, Quality Assurance, Quality Management, Biotechnology, Post Market Surveillance, Validation, V&V, Sop, Medical Devices, Regulatory Affairs, CAPA, 21 CFR Part 11, Lifesciences, GLP, Change Control, Computer System..., Pharmaceutical Industry, Quality Control, ISO 13485, Cross-functional Team..., Manufacturing, Quality Auditing, Biopharmaceuticals, Root Cause Analysis, Regulatory Requirements, Technology Transfer, R&D, Biologics, Process Simulation, Design Control, FDA GMP, ISO 14971, Commercialization, Life Sciences, SOP
Education
San Francisco State University 1984 — 1987
MA, Cellular and Molecular Biology
University of Rhode Island 1977 — 1981
BA, Natural Resources
Suffield High School 1974 — 1977
Alexion Pharmaceuticals, Inc. September 2014 - Present
Stryker November 2009 - September 2014
Stryker Biotech April 2004 - December 2009
Biogen November 1996 - April 2004
genentech 1988 - 1996
Skills
FDA, GMP, Quality System, Quality Assurance, Quality Management, Biotechnology, Post Market Surveillance, Validation, V&V, Sop, Medical Devices, Regulatory Affairs, CAPA, 21 CFR Part 11, Lifesciences, GLP, Change Control, Computer System..., Pharmaceutical Industry, Quality Control, ISO 13485, Cross-functional Team..., Manufacturing, Quality Auditing, Biopharmaceuticals, Root Cause Analysis, Regulatory Requirements, Technology Transfer, R&D, Biologics, Process Simulation, Design Control, FDA GMP, ISO 14971, Commercialization, Life Sciences, SOP
Education
San Francisco State University 1984 — 1987
MA, Cellular and Molecular Biology
University of Rhode Island 1977 — 1981
BA, Natural Resources
Suffield High School 1974 — 1977
Benita Amsden's Stryker Biotech Experience June 2001 - October 2011
Job Senior Development Specialist at Shire HGT
Industry Biotechnology
Experience
Shire HGT April 2012 - Present
Stryker Biotech June 2001 - October 2011
Bayer Diagnostics, Inc January 1999 - June 2001
Bayer August 1996 - June 2001
Bayer HealthCare 1995 - 1999
Bayer Diagnostics 1995 - 1999
Chiron Diagnostics 1995 - 1999
Ciba-Corning Daignostic 1995 - 1999
Skills
SDS-PAGE, ELISA, Lyophilization, Protein Chemistry, Formulation Development, HPLC, Stability Studies, Stability Testing, Karl Fisher, UV/Vis, Solubility, Formulation, Sop, R&D, GMP, Microbiology, GLP, Biotechnology, Validation, FDA, SOP, Technology Transfer, Pharmaceutical Industry
Education
The College of Saint Rose 1992 — 1995
BS, Biochemistry
The College of Saint Rose 1992 — 1995
Bachelor of Science, Biochemistry
Shire HGT April 2012 - Present
Stryker Biotech June 2001 - October 2011
Bayer Diagnostics, Inc January 1999 - June 2001
Bayer August 1996 - June 2001
Bayer HealthCare 1995 - 1999
Bayer Diagnostics 1995 - 1999
Chiron Diagnostics 1995 - 1999
Ciba-Corning Daignostic 1995 - 1999
Skills
SDS-PAGE, ELISA, Lyophilization, Protein Chemistry, Formulation Development, HPLC, Stability Studies, Stability Testing, Karl Fisher, UV/Vis, Solubility, Formulation, Sop, R&D, GMP, Microbiology, GLP, Biotechnology, Validation, FDA, SOP, Technology Transfer, Pharmaceutical Industry
Education
The College of Saint Rose 1992 — 1995
BS, Biochemistry
The College of Saint Rose 1992 — 1995
Bachelor of Science, Biochemistry
Ron Strong's Stryker Biotech Experience August 2005 - August 2010
Job Dural Closure Product Specialist at Integra LifeSciences
Industry Medical Devices
Experience
Integra LifeSciences (Purchased Covidien Biosurgery) January 2014 - Present
Covidien August 2010 - Present
Stryker Biotech August 2005 - August 2010
Novo Nordisk 2002 - 2005
Novartis 1997 - 2002
IKON Office Solutions 1995 - 1997
Skills
Spine, Surgeons, Orthopedic, Neurosurgery, Sales Operations, Selling, Operating Room, Capital Equipment, Disposables, Medical Devices, Surgical Instruments, Market Development, Cardiology, Product Launch, Pharmaceutical Sales, Sales Force Development, Medical Sales, OB/GYN, Vascular
Education
University of Missouri-Columbia 1991 — 1995
Bachelor of Science (B.S.)
Integra LifeSciences (Purchased Covidien Biosurgery) January 2014 - Present
Covidien August 2010 - Present
Stryker Biotech August 2005 - August 2010
Novo Nordisk 2002 - 2005
Novartis 1997 - 2002
IKON Office Solutions 1995 - 1997
Skills
Spine, Surgeons, Orthopedic, Neurosurgery, Sales Operations, Selling, Operating Room, Capital Equipment, Disposables, Medical Devices, Surgical Instruments, Market Development, Cardiology, Product Launch, Pharmaceutical Sales, Sales Force Development, Medical Sales, OB/GYN, Vascular
Education
University of Missouri-Columbia 1991 — 1995
Bachelor of Science (B.S.)
Elliot Haimes's Stryker Biotech Experience May 2001 - January 2002
Job Biotechnology Professional & Agricultural Farmer
Industry Biotechnology
Experience
Nicewicz Farm July 2015 - Present
Lyft July 2015 - Present
Uber May 2015 - July 2015
Thermo Fisher Scientific (Life Technologies) January 2010 - April 2015
Virdante September 2009 - December 2009
Dyax June 2004 - March 2009
Protein Forest, Inc. March 2004 - June 2004
Matritech March 2002 - November 2003
Stryker Biotech May 2001 - January 2002
Skills
Assay Development, ELISA, SDS-PAGE, Protein Purification, HPLC, Tissue Culture, Chromatography, Monoclonal Antibodies, Analytical Chemistry, Antibodies, GMP, Viral Clearance, AKTA, Minitab, Technical Support, Technology Transfer, Ion Exchange, Hydrophobic Interaction..., Affinity Chromatography, Column Packing, Purification, Gel Electrophoresis, Protein Chemistry, Cell Culture, Biochemistry, FPLC, Customer Support, Product Marketing, Product Placement, Market Research, E1, SAP ERP, Biotechnology, Validation, Life Sciences, R&D
Education
University of Massachusetts, Amherst 1997 — 2001
Bachelor of Science, Biology
Nicewicz Farm July 2015 - Present
Lyft July 2015 - Present
Uber May 2015 - July 2015
Thermo Fisher Scientific (Life Technologies) January 2010 - April 2015
Virdante September 2009 - December 2009
Dyax June 2004 - March 2009
Protein Forest, Inc. March 2004 - June 2004
Matritech March 2002 - November 2003
Stryker Biotech May 2001 - January 2002
Skills
Assay Development, ELISA, SDS-PAGE, Protein Purification, HPLC, Tissue Culture, Chromatography, Monoclonal Antibodies, Analytical Chemistry, Antibodies, GMP, Viral Clearance, AKTA, Minitab, Technical Support, Technology Transfer, Ion Exchange, Hydrophobic Interaction..., Affinity Chromatography, Column Packing, Purification, Gel Electrophoresis, Protein Chemistry, Cell Culture, Biochemistry, FPLC, Customer Support, Product Marketing, Product Placement, Market Research, E1, SAP ERP, Biotechnology, Validation, Life Sciences, R&D
Education
University of Massachusetts, Amherst 1997 — 2001
Bachelor of Science, Biology
Ethan Faryna's Stryker Biotech Experience July 2004 - October 2004
Job Technology Manager at YellowJacket Racing
Industry Nonprofit Organization Management
Experience
University of Puerto Rico July 2013 - Present
YellowJacket Racing January 2012 - July 2012
National MS Society Upstate New York Chapter October 2011 - January 2012
Country Way Garden Center & Landscape May 2011 - October 2011
YellowJacket Racing March 2010 - May 2011
UCB Pharma October 2004 - March 2010
Stryker Biotech July 2004 - October 2004
Halo Farms 1994 - 2004
Skills
Manufacturing, Pharmaceutical Industry, Microsoft Office, Microsoft Excel, PowerPoint, Biotechnology, GMP, Sales, Sop, Microscopy, Management, Testing, Windows, Employee Training, Troubleshooting, Validation, Data Analysis, Macroeconomics
Education
Rochester Institute of Technology 2000 — 2004
Bachelor of Science, Biotechnology
Genesee Community College 1999 — 2000
University of Puerto Rico July 2013 - Present
YellowJacket Racing January 2012 - July 2012
National MS Society Upstate New York Chapter October 2011 - January 2012
Country Way Garden Center & Landscape May 2011 - October 2011
YellowJacket Racing March 2010 - May 2011
UCB Pharma October 2004 - March 2010
Stryker Biotech July 2004 - October 2004
Halo Farms 1994 - 2004
Skills
Manufacturing, Pharmaceutical Industry, Microsoft Office, Microsoft Excel, PowerPoint, Biotechnology, GMP, Sales, Sop, Microscopy, Management, Testing, Windows, Employee Training, Troubleshooting, Validation, Data Analysis, Macroeconomics
Education
Rochester Institute of Technology 2000 — 2004
Bachelor of Science, Biotechnology
Genesee Community College 1999 — 2000
Stephen Krom's Stryker Biotech Experience 2001 - June 2004
Job Senior Manager — Engineering, Manufacturing & EHS with a strong Quality, Safety, and Profitability Focus
Industry Biotechnology
Experience
Olympus Biotech Corporation July 2012 - Present
Styker Biotech / Olympus Biotech Corporation 2004 - 2012
Stryker Biotech 2001 - June 2004
Morton International, Inc / Rohm and Haas Company 1994 - 2001
Skills
cGMP Operations..., Corrective and..., Process Safety..., OSHA Voluntary..., Standard Operating..., Risk Analysis, Design Control, Project Management, Organizational..., Technology Transfer, Validation, cGMP, GxP, Change Management, Engineering Data..., Investigations, Root Cause Analysis, Troubleshooting, Medical Devices, Capital Budgeting, Operating Budgets, Hazard Analysis, Hazardous Waste..., Environmental..., process validation, Statistical Process..., OSHA Record Keeping, Lean Manufacturing, Continuous Improvement, 5S, Environmental Permitting, SARA Title III, Process Engineering
Education
University of Massachusetts, Amherst
BS, Chemical Engineering
Olympus Biotech Corporation July 2012 - Present
Styker Biotech / Olympus Biotech Corporation 2004 - 2012
Stryker Biotech 2001 - June 2004
Morton International, Inc / Rohm and Haas Company 1994 - 2001
Skills
cGMP Operations..., Corrective and..., Process Safety..., OSHA Voluntary..., Standard Operating..., Risk Analysis, Design Control, Project Management, Organizational..., Technology Transfer, Validation, cGMP, GxP, Change Management, Engineering Data..., Investigations, Root Cause Analysis, Troubleshooting, Medical Devices, Capital Budgeting, Operating Budgets, Hazard Analysis, Hazardous Waste..., Environmental..., process validation, Statistical Process..., OSHA Record Keeping, Lean Manufacturing, Continuous Improvement, 5S, Environmental Permitting, SARA Title III, Process Engineering
Education
University of Massachusetts, Amherst
BS, Chemical Engineering
Jim Stahl's Stryker Biotech Experience September 1999 - October 2011
Job Director of Analytical Development at Promedior
Industry Biotechnology
Experience
Promedior, Inc. January 2013 - Present
Blue Stream Laboratories December 2011 - December 2012
Stryker Biotech September 1999 - October 2011
Utah State University September 1997 - August 1999
Intech 180 June 1995 - September 1997
Utah State University September 1988 - May 1995
Skills
Analytical Chemistry, Quality by Design, HPLC, Protein Chemistry, GMP, SDS-PAGE, Characterization, Protein Characterization, Analytical Techniques, cGMP, UV-Vis, GLP, Biotechnology, Process Validation, Chromatography, R&D, ELISA, Western Blotting, Pharmaceutical..., Pharmaceuticals, Biopharmaceuticals, Cell Based Assays, UV, IND, Validation, Formulation, Assay Development, UV/Vis, V&V
Education
Utah State University 1988 — 1995
Ph.D., Biochemistry
University of Cincinnati 1982 — 1987
B.S., Chemical Engineering
Promedior, Inc. January 2013 - Present
Blue Stream Laboratories December 2011 - December 2012
Stryker Biotech September 1999 - October 2011
Utah State University September 1997 - August 1999
Intech 180 June 1995 - September 1997
Utah State University September 1988 - May 1995
Skills
Analytical Chemistry, Quality by Design, HPLC, Protein Chemistry, GMP, SDS-PAGE, Characterization, Protein Characterization, Analytical Techniques, cGMP, UV-Vis, GLP, Biotechnology, Process Validation, Chromatography, R&D, ELISA, Western Blotting, Pharmaceutical..., Pharmaceuticals, Biopharmaceuticals, Cell Based Assays, UV, IND, Validation, Formulation, Assay Development, UV/Vis, V&V
Education
Utah State University 1988 — 1995
Ph.D., Biochemistry
University of Cincinnati 1982 — 1987
B.S., Chemical Engineering
Derek Jean's Stryker Biotech Experience May 2004 - December 2007
Job Anika Therapeutics
Industry Medical Devices
Experience
Anika Therapeutics March 2009 - Present
Contract Manufacturing December 2007 - January 2009
Stryker Biotech May 2004 - December 2007
Bristol-Myers Squibb / Dupont Pharmaceuticals March 1997 - May 2004
Biosurface/Genzyme Biosurgery January 1990 - July 1996
Skills
CAPA, Purification, Change Control, FDA, V&V, Troubleshooting, Validation, Manufacturing, Medical Devices, Lifesciences, Pharmaceutical Industry, Technology Transfer, 21 CFR Part 11, Cell, GMP, LIMS, Process Improvement, Formulation, Quality System, Automation, Sop, Biopharmaceuticals, Aseptic Processing, Training, Management, Quality Assurance, Biotechnology, Quality Control, Cleaning Validation, ISO 13485, Process Simulation, Chromatography, Aseptic Technique, Root Cause Analysis, Cell Culture, Sterilization, Cross-functional Team..., Filtration, Continuous Improvement, Environmental Monitoring, CIP, Quality Auditing, Clean Rooms, Lean Manufacturing, Drug Delivery, Lyophilization, Contract Manufacturing, cGMP manufacturing, Downstream Processing, cGMP practices
Education
University of Massachusetts Lowell
Biology
Austin Prep 1982 — 1986
Diploma, College Prep Studies
Anika Therapeutics March 2009 - Present
Contract Manufacturing December 2007 - January 2009
Stryker Biotech May 2004 - December 2007
Bristol-Myers Squibb / Dupont Pharmaceuticals March 1997 - May 2004
Biosurface/Genzyme Biosurgery January 1990 - July 1996
Skills
CAPA, Purification, Change Control, FDA, V&V, Troubleshooting, Validation, Manufacturing, Medical Devices, Lifesciences, Pharmaceutical Industry, Technology Transfer, 21 CFR Part 11, Cell, GMP, LIMS, Process Improvement, Formulation, Quality System, Automation, Sop, Biopharmaceuticals, Aseptic Processing, Training, Management, Quality Assurance, Biotechnology, Quality Control, Cleaning Validation, ISO 13485, Process Simulation, Chromatography, Aseptic Technique, Root Cause Analysis, Cell Culture, Sterilization, Cross-functional Team..., Filtration, Continuous Improvement, Environmental Monitoring, CIP, Quality Auditing, Clean Rooms, Lean Manufacturing, Drug Delivery, Lyophilization, Contract Manufacturing, cGMP manufacturing, Downstream Processing, cGMP practices
Education
University of Massachusetts Lowell
Biology
Austin Prep 1982 — 1986
Diploma, College Prep Studies
Chad Harrington's Stryker Biotech Experience July 2009 - January 2011
Job LNA at Dartmouth Hitchcock Medical Center
Industry Hospital & Health Care
Experience
Dartmouth Hitchcock Medical Center July 2012 - Present
Olympus Biotech July 2009 - July 2012
Stryker Biotech July 2009 - January 2011
Stryker Biotech 2008 - 2009
Stryker Biotech 2005 - 2008
Skills
21 CFR Part 11, Automation, CAPA, Calibration, Change Control, Computer System..., Continuous Improvement, Engineering, Biotechnology, FDA, GMP, GxP, ISO 13485, Lifesciences, Manufacturing, Medical Devices, Microsoft Office, Pharmaceutical Industry, Process Engineering, Process Improvement, Project Management, Quality Assurance, Quality System, Root Cause Analysis, Sop, Testing, Troubleshooting, V, Validation, Windows
Education
River Valley Community College 2012 — 2014
Practical Nursing, Vocational Nursing and Nursing Assistants
Regis University 2007 — 2009
MBA, General Business
Vermont Technical College 2002 — 2006
BS, Electro-Mechanical Engineering
Dartmouth Hitchcock Medical Center July 2012 - Present
Olympus Biotech July 2009 - July 2012
Stryker Biotech July 2009 - January 2011
Stryker Biotech 2008 - 2009
Stryker Biotech 2005 - 2008
Skills
21 CFR Part 11, Automation, CAPA, Calibration, Change Control, Computer System..., Continuous Improvement, Engineering, Biotechnology, FDA, GMP, GxP, ISO 13485, Lifesciences, Manufacturing, Medical Devices, Microsoft Office, Pharmaceutical Industry, Process Engineering, Process Improvement, Project Management, Quality Assurance, Quality System, Root Cause Analysis, Sop, Testing, Troubleshooting, V, Validation, Windows
Education
River Valley Community College 2012 — 2014
Practical Nursing, Vocational Nursing and Nursing Assistants
Regis University 2007 — 2009
MBA, General Business
Vermont Technical College 2002 — 2006
BS, Electro-Mechanical Engineering
Sundae Zehner's Stryker Biotech Experience October 2007 - October 2008
Job West Area Franchise Manager, LifeCell
Industry Medical Devices
Experience
LifeCell, an Acelity company September 2015 - Present
Sientra, Inc. October 2013 - September 2015
LifeCell Corporation October 2008 - October 2013
Stryker Biotech October 2007 - October 2008
Smith & Nephew June 2004 - September 2007
Skills
Medical Devices, Surgery, Orthopedics, Capital Equipment, Cardiology, Disposables, Market Development, Operating Room, Orthopedic, Product Launch, Sales, Sales Operations, Surgeons
Education
University of California, San Diego
Economics
LifeCell, an Acelity company September 2015 - Present
Sientra, Inc. October 2013 - September 2015
LifeCell Corporation October 2008 - October 2013
Stryker Biotech October 2007 - October 2008
Smith & Nephew June 2004 - September 2007
Skills
Medical Devices, Surgery, Orthopedics, Capital Equipment, Cardiology, Disposables, Market Development, Operating Room, Orthopedic, Product Launch, Sales, Sales Operations, Surgeons
Education
University of California, San Diego
Economics
Katlyn Haskell's Stryker Biotech Experience September 2010 - November 2011
Job Associate IIResearch and Development at Organogenesis
Industry Biotechnology
Experience
Organogenesis January 2012 - February 2014
Stryker Biotech September 2010 - November 2011
Sanford Brown Institute June 2010 - September 2010
Charles River Laboratories February 2009 - June 2010
Charles River Laboratories April 2008 - February 2009
Charles River Laboratories January 2007 - April 2008
CVS Caremark Corporation July 2000 - January 2007
Skills
Sop, GMP, GLP, Pharmaceutical Industry, Cell Culture, Cross-functional..., HPLC, Biotechnology, Design of Experiments, Assay Development, Technology Transfer, CAPA, ELISA, SOP, Protein Chemistry
Education
University of Rhode Island 2002 — 2006
BS, Biology
Organogenesis January 2012 - February 2014
Stryker Biotech September 2010 - November 2011
Sanford Brown Institute June 2010 - September 2010
Charles River Laboratories February 2009 - June 2010
Charles River Laboratories April 2008 - February 2009
Charles River Laboratories January 2007 - April 2008
CVS Caremark Corporation July 2000 - January 2007
Skills
Sop, GMP, GLP, Pharmaceutical Industry, Cell Culture, Cross-functional..., HPLC, Biotechnology, Design of Experiments, Assay Development, Technology Transfer, CAPA, ELISA, SOP, Protein Chemistry
Education
University of Rhode Island 2002 — 2006
BS, Biology
Melissa Haskell, DVM, DABT's Stryker Biotech Experience July 2008 - October 2011
Job Director of NonClinical Toxicology, Attending Veterinarian at Alexion Pharmaceuticals
Industry Research
Experience
Alexion Pharmaceuticals, Inc. June 2015 - Present
Alexion Pharmaceuticals July 2012 - June 2015
Biomedical Research Models, Inc. January 2012 - 2012
Stryker Biotech July 2008 - October 2011
Charles River Laboratories July 2006 - July 2008
Skills
Lifesciences, Pharmacology, Clinical Development, Biotechnology, Clinical Research, Surgery, CRO, Molecular Biology, Sop, Microbiology, Protocol, Pharmaceutical Industry, Animal Models, Medical Devices, Vaccines, Toxicology, GLP, Equine Reproduction, IACUC, Infectious Diseases, Regulatory Submissions, Veterinary, Immunology, Drug Development, R&D, IND, In Vitro, Oncology, Clinical Trials, ELISA, Regulatory Affairs, Drug Discovery, Neuroscience, Life Sciences, SOP
Education
North Carolina State University College of Veterinary Medicine 2001 — 2005
DVM
University of Massachusetts, Amherst 1997 — 2001
Alexion Pharmaceuticals, Inc. June 2015 - Present
Alexion Pharmaceuticals July 2012 - June 2015
Biomedical Research Models, Inc. January 2012 - 2012
Stryker Biotech July 2008 - October 2011
Charles River Laboratories July 2006 - July 2008
Skills
Lifesciences, Pharmacology, Clinical Development, Biotechnology, Clinical Research, Surgery, CRO, Molecular Biology, Sop, Microbiology, Protocol, Pharmaceutical Industry, Animal Models, Medical Devices, Vaccines, Toxicology, GLP, Equine Reproduction, IACUC, Infectious Diseases, Regulatory Submissions, Veterinary, Immunology, Drug Development, R&D, IND, In Vitro, Oncology, Clinical Trials, ELISA, Regulatory Affairs, Drug Discovery, Neuroscience, Life Sciences, SOP
Education
North Carolina State University College of Veterinary Medicine 2001 — 2005
DVM
University of Massachusetts, Amherst 1997 — 2001
Rebeca Kukowski's Stryker Biotech Experience December 2001 - December 2005
Job
Industry Biotechnology
Experience
MatTek Corporation 2014 - 2014
Stryker Biotech December 2001 - December 2005
Skills
Biotechnology, Medical Devices, FDA, Biomedical Engineering, Lifesciences, CAPA, Management
Education
University of Illinois at Urbana-Champaign
Bachelor of Science (BS), Environmental Biology
MatTek Corporation 2014 - 2014
Stryker Biotech December 2001 - December 2005
Skills
Biotechnology, Medical Devices, FDA, Biomedical Engineering, Lifesciences, CAPA, Management
Education
University of Illinois at Urbana-Champaign
Bachelor of Science (BS), Environmental Biology
Life Technologies
Vertex Pharmaceuticals
PDL BioPharma
Medarex
Vertex
Eppendorf
Vertex Pharmaceuticals Inc.
NanoString Technologies, Inc.