CMC VP, Small Molecule
Job Title: CMC VP, Small molecule
Report to: Head of CMC
- CMC Strategy and Planning: Collaborate with the Company Teams to closely plan CMC programs (drug substance and drug product manufacturing and analytical activities), from preclinical development through clinical supplies for Phase 3 registration studies, including projection of API/DP needs, budgets, and timelines. Develop and implement a strategy and DOE (design of experimentation) for optimizing and controlling quality of bulk API and DP using CROs and CMOs. Execute plans in accordance with GMP, ICH and FDA regulations. Partner with and maintain regular contact with key stakeholders including, Quality Assurance, Regulatory Affairs, Medical, Legal, Finance, and Program Management. Write and review relevant sections for regulatory submissions.
- Partner Collaborations: Identify, select, and manage Contract Manufacturing Organizations (CMOs) for process optimization, GMP/GCP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of ongoing clinical programs.
- Program Execution and Oversight: Oversee the tactical implementation of the manufacturing programs, including delivery of scalable and cost-effective manufacturing routes that meet or exceed the target clinical profile. Manage supply chain and logistics in support of clinical studies. Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents.
- PhD/MS in science (e.g., organic chemistry, chemistry, pharmaceutical sciences, or related discipline)
- Pharmaceutical/biotechnology industry experience (minimum 10 years) in managing China CRO/CMOs for the manufacture of GMP/GCP APIs and DP. Experience with projects preclinical through Phase 3 including multiple dosage forms and small molecule; biologics experience a plus)
- Strong leadership skills with ability to be hands-on and lead/manage the CMC programs.
- Thorough knowledge of GMP manufacturing and IND, CTA, and NDA filings; thorough and relevant knowledge of FDA and EMA regulations
- Strong skills in identifying and resolving critical issues.
- Strong track record in effectively working with senior management.
- Proven ability to work collaboratively internally and externally, with the ability to manage multiple stakeholders.
- Results oriented and self-assured. Ability to push timetables while keeping the team motivated.