Senior Manager, Peptide Drug Substance – External Manufacturing (CMC)
Clinical-stage oncology biotech | Remote (US) |
A venture-backed, clinical-stage oncology company is hiring a Senior Manager to run its outsourced peptide drug substance supply. You'll be the main point of contact for its contract manufacturers, moving several programs from process development into clinical GMP supply. The CMC team is small and lean, so you'll get real ownership and direct exposure to senior leadership.
What you'll own
Day-to-day oversight of CDMO partners across process development, scale-up, tech transfer, GMP campaigns and release testing
Reviewing and approving executed batch records, campaign plans, protocols and technical reports
Tracking stability programs end to end and escalating issues early
Leading deviations, change controls and CAPAs alongside Quality
Coordinating with supply chain on material availability, production timelines and clinical demand
Managing the commercial side of each partnership: SOWs, POs, change orders, invoices and budget tracking
What you bring
BS or higher in chemistry, chemical engineering, biochemistry, pharmaceutical sciences or a related field
5+ years in pharma/biotech process development or external manufacturing (peptide, biologics or small molecule)
Sponsor-side experience managing CDMOs
Hands-on GMP documentation experience and a working knowledge of cGMP and validation
Comfort working independently in a fast-moving startup
Nice to have
Solid-phase peptide synthesis, peptide purification and analytical characterization
Experience taking a peptide into Phase 1/2 clinical supply
Experience owning CDMO contracts and budgets
This search is confidential and handled by Discover International. Applications are reviewed directly by the recruiter, and the client's name is shared after an initial conversation.