John Lancaster

Senior Director, Pharmaceutical Operations @La Jolla Pharmaceutical Company

San Diego, CA, US
MOBILE NUMBERS
+16•••••••68

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WORK HISTORY

Jan 2019 — Present

Senior Director, Pharmaceutical Operations @La Jolla Pharmaceutical Company

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San Diego, CA, US

EDUCATION

1993 — 1994

Northwestern University

M.S., Organic Chemistry

1989 — 1993

DePauw University

B.S., Chemistry

SKILLS

Protein ChemistryCapaNdaGxpQuality AuditingAseptic Processing21 Cfr Part 11Drug DevelopmentChange ControlBiopharmaceuticalsRegulatory AffairsQuality SystemQuality SystemsV&VGlpRegulatory RequirementsCorrective and Preventive Action (Capa)IndOncologyBiotechnologyGood Laboratory Practice (Glp)CgmpBiologicsEctdSopFdaRegulatory SubmissionsTechnology TransferFormulationQuality AssuranceStandard Operating Procedure (Sop)ValidationQuality ControlGmp

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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