Senior Manager

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.

• 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

• 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

• 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