John Lancaster
Senior Director, Pharmaceutical Operations @La Jolla Pharmaceutical Company
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WORK HISTORY
Senior Director, Pharmaceutical Operations @La Jolla Pharmaceutical Company
San Diego, CA, US
EDUCATION
Northwestern University
M.S., Organic Chemistry
DePauw University
B.S., Chemistry
SKILLS
ABOUT JOHN LANCASTER
Product Development with Quality and Regulatory Emphasis• Drug Substance/API: CMO Management for Process Development, GMP Manufacturing, MIP• Drug Product: CMO Management for Formulation Development, Method Transfer, Site Transfer, GMP Manufacturing• Quality: GXP Quality Systems, Quality Audits, GMP Training Material Development, SOP Development• Biologics: Manufacturing Process, Development of QC Assays, GMP Sterile Fill Manufacturing• Project Management: Timeline Management, Contractor Management, Team Development• Regulatory Submissions (NDA, IND, IMPD, updates)Specialties: CMC Development, Supplier/CMO Management, Quality System Implementation and Management, Regulatory Strategy and Submissions, Validation and Technical Writing
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