Head of Biologics Drug Substance - Menlo Park, CA, United States - Meet Recruitment Limited

Description

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.

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.
or equivalent in biology, biochemistry, chemical engineering, biochemical engineering or related field.
~Extensive experience selecting and managing domestic and international external vendors including CMOs, CDMOs, etc.
~ Experience authoring regulatory filings (IND, CTA, BLA, etc.)
~ Demonstrated successfully managing multiple projects at once.