VP / Director, CMC and Process Development

CONFIDENTIAL RETAINED SEARCH | SAN DIEGO LIFE SCIENCES

Search Reference: TNF-LS-CMC-2026 | Technical Operations Leadership Mandate, Life Sciences

ABOUT THIS SEARCH

Top Notch Finders has been retained on an exclusive and strictly confidential basis to identify a VP/Director of CMC and Process Development for a client in the San Diego / CaliBaja life sciences corridor. To protect the interests of our client and of every candidate who engages with us, the identity of the company is disclosed only to qualified candidates under a confidentiality agreement. All inquiries and applications are received and managed solely by Top Notch Finders.

POSITION SNAPSHOT

• Company profile: Cell/gene therapy, ADC, biologics, or peptide biotech, clinical through commercial stage.
• Reports to: CSO, CTO, or COO.
• Location: San Diego / CaliBaja region; specifics disclosed to qualified candidates.

THE OPPORTUNITY

The VP/Director of CMC and Process Development leads chemistry, manufacturing, and controls strategy, including process development, tech transfer, scale-up, and GMP compliance, in what is consistently identified as the single tightest leadership specialty in biotech hiring.

KEY RESPONSIBILITIES

• Own end-to-end CMC strategy from process development through commercial manufacturing.
• Lead technology transfer between internal labs, CDMOs, and commercial manufacturing sites.
• Ensure GMP compliance across all manufacturing operations and inspection readiness.
• Manage analytical development, formulation, and stability programs.
• Partner with Regulatory Affairs on CMC sections of IND/BLA/NDA filings.
• Oversee supply chain and raw material sourcing strategy, including de-risking single-source dependencies.
• Build and scale the CMC/technical operations organization to support pipeline growth.

REQUIRED QUALIFICATIONS

• Advanced degree in chemistry, chemical engineering, biochemistry, or a related field; PhD preferred at the VP level.
• 12-15+ years of CMC and process development leadership experience.
• Modality-specific expertise in cell therapy, gene therapy, or ADC manufacturing is frequently required and commands a premium.
• Demonstrated experience successfully scaling a process from clinical to commercial manufacturing.
• Direct experience with GMP inspections and health authority manufacturing audits.
• Strong CDMO management and technical negotiation skills.

CONFIDENTIALITY AND HOW TO APPLY

This is a discreet, retained engagement. Your candidacy will never be presented to any organization without your explicit prior authorization, and no application will be visible to the hiring company at this stage. Accomplished CMC and technical operations leaders are invited to submit a resume in confidence through the Top Notch Finders website. Please reference search code TNF-LS-CMC-2026 in your submission. Do not include patient-identifiable, trial-blinded, or other confidential clinical information of any kind in your application materials. Only candidates whose backgrounds align closely with the mandate will be contacted.