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James Stonecypher Location
Los Angeles, CA, US
James Stonecypher Work
Chief Development Officer (CDO) @ (August 2023 - Present)
Global SVP, Regulatory Affairs and Quality Science @ (December 2022 - August 2023)
Founder, Principal Consultant @ (January 2015 - December 2022)
President and Chief Regulatory Officer @ (February 2018 - March 2022)
Senior Vice President, Regulatory Affairs and Quality @ (January 2015 - January 2018)
Director of Regulatory Affairs and Department Head, Global CMC @ (January 2012 - January 2015)
Senior Director and Head, Technical Operations @ (April 2011 - September 2012)
Global Product Leader, Regulatory Affairs CMC @ (January 2003 - January 2011)
Global Product Leader, Regulatory Affairs CMC @ (January 2002 - January 2003)
Head of Quality Assurance @ (January 2000 - January 2002)
Research Associate Iii, Molecular Oncology @ (January 1998 - January 2000)
Laboratory Technician, Molecular Biology @ (January 1996 - January 1998)
James Stonecypher Education
North Carolina State University
Masters
James Stonecypher Skills
Regulatory Affairs
Drug Development
Biotechnology
Oncology
Pharmaceutical Industry
Clinical Trials
FDA
GMP
Regulatory Submissions
CMC
Biopharmaceuticals
Life Sciences
Validation
Sop
R&D
Clinical Development
Molecular Biology
Immunology
Biologics
GLP
Technology Transfer
Manufacturing
eCTD
Strategy
Medical Devices
Quality Assurance
CRO
cGMP
Quality by Design
Risk Management
Lifesciences
Toxicology
IND
Drug Delivery
GCP
Pharmaceuticals
Regulatory Strategy
Operational Excellence
Drug Discovery
Clinical Research
CAPA
Regulatory Requirements
21 CFR Part 11
Change Control
Commercialization
Therapeutic Areas
Management
Quality
Comparability
See 32+see Less
James Stonecypher Summary
James Stonecypher, based in Los Angeles, CA, US, is currently a Chief Development Officer (CDO) at Telix Pharmaceuticals Limited. James Stonecypher brings experience from previous roles at Telix Pharmaceuticals Limited, Biologics Development Partners, Object Pharma, Inc. and Bonti - acquired by Allergan-AbbVie. James Stonecypher holds a Masters @ North Carolina State University. With a robust skill set that includes Regulatory Affairs, Drug Development, Biotechnology, Oncology, Pharmaceutical Industry and more. James Stonecypher has 2 emails on RocketReach.
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