Provide Chemistry, Manufacturing, and Control (CMC) support of Vivus Product Development Programs and Projects including API sourcing, contract development, manufacturing, testing, and packaging sourcing and oversight. Provide IND and NDA CMC section support including review and approval of all source documentation and data, draft sections, and support all CMC related regulatory filings and agency comments. Evaluate and recommend Product Development CMC Strategy to Support Clinical, Marketing, and Corporate Objectives including dosage form selection, manufacturing process, packaging, and quality systems.
- Support the CMC department head as follows.
- Assume all or part of CMC related product development projects.
- Source API as needed, including second sourcing, cost analysis, contracts, and quality agreements as needed.
- Provide API cGMP oversight as needed.
- Evaluate and recommend, as needed, contracted sources for formulation development, analytical development, validation and testing, manufacturing, clinical supply chain management.
- Provide oversight of all contracted CMC services to achieve project objectives, manage timelines, control costs, and meet project objectives.
- Review and approve as needed batch records, specifications, test methods, and related documentation to release drug, excipients, and drug products for clinical use and regulatory filings.
- Draft IND/NDA CMC amendments and sections in compliance applicable regulatory guidance and supporting corporate development strategy and objectives.
- BS/BA, MS, or Ph.D. in a science field, e.g. Pharmaceutics, Chemistry, Biochemistry, Chemical Engineering, Physics, or Biology.
- 10+ years pharmaceutical industry experience in CMC related areas including API cGMPs, formulation development, analytical development, process development, packaging, clinical supply chain management, QA/QC, IND/NDA submissions, and product launch.
- Thorough knowledge of FDA and ICH guidance documents with the demonstrated ability to apply them pragmatically.
- Excellent oral and written communication skills and project team skills.
- Demonstrated ability to think strategically and tactically to support clinical, marketing and corporate product goals and objectives.
VIVUS Inc. - 2 years ago