VP/Head of Product Development & Manufacturing (PDM)
Manufacturing | South San Francisco, CA | Full Time | Opened about 1 month ago
About the Company and Role:
Vera Therapeutics is a clinical-stage biotechnology company focused on developing treatments for immunological and Inflammatory diseases that improve patients’ lives. We seek a highly skilled and motivated VP of PDM to join a fast-paced and collaborative team. The VP of PDM will be the senior leader for all CMC deliverables, including clinical supplies, tech transfer, scale up, BLA readiness for both drug substance and drug product and the CMC filings and negotiations. The individual will also be accountable for selection of and the management of CMOs, setting CMC strategy for the company, and representing all aspects of CMC on the cross-functional project team. The ideal candidate will have prior experience leading biologic CMC activities from the lead optimization phase through to commercialization.
- Overall responsibility for all drug substance, product process, analytical development and manufacturing activities from clinical development through commercialization
- Identification, selection and management of Contract Development & Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture of Drug Substance (DS) and Drug Product (DP) in support of ongoing clinical programs and subsequent commercial supply in compliance with cGMP, ICH and FDA regulations
- CMC representative on the project team. Proactively identifying knowledge gaps and risks, and working with the team to develop mitigation plans
- CMC representative for the tech transfer in-house of a biologic from a large pharma partner
- Own the technical content of the CMC sections of INDs, CTAs, BLA/MAAs and other regulatory submissions; represent the company as the CMC expert before regulatory authorities
- PhD or MS with 12+ years of experience in product development and manufacturing; Advanced degree in Biology, Biochemistry, Pharmaceutical Chemistry, Pharmaceutical Science, Chemical Engineering, or related scientific discipline preferred. Experience in biologics is required
- Experience with upstream and downstream biologics process development and development of supporting analytical methods, for both product characterization and release.
- Experience with late-stage clinical development of biologics, including process validation and pre-approval regulatory inspections (PAI)
- Experienced in cGMP manufacturing and a proved track record leveraging and managing US and International CRO/CMOs for the manufacture of cGMP DS and DP
- A proven track record guiding the CMC sections/quality modules for regulatory submissions and knowledge of current US and EU regulations. An ability to identify and resolve critical issues
- Strong interpersonal skills are required, and the successful candidate will work in a cross-functional team and will be expected to influence the direction of the late-stage clinical programs
- Excellent written and verbal communication skills with an ability to convey CMC strategy and results to a varied audience
- Meticulous, self-motivated, decisive, and independent with a willingness to work in a fast-paced start up environment
Vera Therapeutics is an equal opportunity employer.