Senior Manager

Discover International

Boston (MA)

Remote

USD 120,000 - 170,000

Full time

7 days ago
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Job summary

Discover International is seeking a Senior Manager to lead outsourced peptide drug substance manufacturing with direct interaction with contract manufacturers. You will drive programs from process development to clinical GMP supply, owning documentation, quality events, and budget tracking.

The role requires hands-on GMP knowledge, sponsor-side CDMO management, and the ability to operate in a fast-moving startup environment. Remote (US) work is supported.

Qualifications

  • 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 knowledge of cGMP and validation.
  • Comfort working independently in a fast-moving startup.

Responsibilities

  • Oversee CDMO partners across process development, scale-up, tech transfer, GMP campaigns, and release testing.
  • Review and approve batch records, campaign plans, protocols, and technical reports.
  • Track stability programs end-to-end and escalate issues early.
  • Lead deviations, change controls and CAPAs with Quality.
  • Coordinate with supply chain on material availability, production timelines, and clinical demand.
  • Manage the commercial side of partnerships: SOWs, POs, change orders, invoices, and budgets.

Skills

Process development
CDMO management
GMP documentation
Independent startup

Education

BS or higher in chemistry/biotech/pharma

Job description

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
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