VP/Head of Product Development & Manufacturing (PDM)
Manufacturing | South San Francisco, CA | Full Time | Opened 23 days ago
About the Company and Role:
Vera Therapeutics Inc. is a clinical-stage biotechnology company developing innovative biologic therapeutics with transformative potential. 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, 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 cross-functional project team. The ideal candidate will have prior experience leading biologic CMC activities within a biotechnology company from the lead optimization phase through to commercialization.
- Overall responsibility for all drug substance and drug product process and 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 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 identify knowledge gaps and risks, and work with the team to develop mitigation plans.
- Prepare 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 Biochemistry, Pharmaceutical Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering or related scientific discipline preferred. Experience in biologics required and small molecule drug development experience is a plus.
- 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 APIs and DP to meet aggressive timelines.
- A proven track record writing 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 strategies 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.