Head of Biologics Drug Substance

I'm partnered with an SF Bay Area-based clinical staged biopharmaceutical company focused on the treatment of liver and cardio-metabolic diseases. This position will be reporting to the VP of CMC and will support the drug development and manufacturing activities for phase 3 and commercialization at CDMOs and CTLs for Biologic programs.

Responsibilities:

Lead all Drug-substance efforts and be responsible for process transfer, process scale-up, and commercialization in the biologics space.

Act as expert for CMC process validation and related responsibilities.

Manage global CDMOs for tech transfers, process optimization, process scale-up, and cGMP manufacturing for ongoing clinical programs and commercial launches for drug substance programs.

Write and review technical documents including development reports, tech transfer reports, manufacturing batch records, and other related documents.

Author and review regulatory documents for CMC sections.

Qualifications:

B.S., M.S., or equivalent in biology, biochemistry, chemical engineering, biochemical engineering or related field.

20+ years of industry experience in CMC process development and manufacturing

Extensive experience selecting and managing domestic and international external vendors including CMOs, CDMOs, etc.

Strong experience with process development, scale-ups, and tech transfers.

Experience authoring regulatory filings (IND, CTA, BLA, etc.)

Demonstrated successfully managing multiple projects at once.

If you're intersted in hearing more please apply or send your resume to