Serve as program lead for external peptide manufacturing, accountable for end-to-end execution across development, clinical, and commercial stages
Act as a primary interface with CDMOs, working alongside the site lead to ensure alignment on program priorities and deliverables
Drive technology transfer, scale-up, and process readiness in collaboration with Process Development and site teams
Provide oversight of manufacturing activities to ensure readiness for GMP operations
Identify and manage program risks (technical, supply, regulatory) and drive mitigation strategies
Partner cross-functionally (Process Development, Analytical, Quality, Supply Chain, Regulatory) to ensure integrated execution
Support sourcing and externalization activities including Scope of Work (SoW) development and supplier engagement
Ensure adherence to cGMP requirements and Amgen business processes including deviations, change control, and investigations
Monitor and manage program performance across timeline, quality, and cost, escalating issues as needed
Present program updates, risks, and recommendations to senior management
Occasional domestic and international travel
Win
What we expect of you
Basic Qualifications
Any degree with 8-13 years of experience
Preferred Qualifications
Experience leading external manufacturing programs at CDMOs, preferably in peptides or related modalities
Demonstrated experience in technology transfer, scale-up, and GMP readiness
Strong understanding of drug substance development through commercial manufacturing
Experience working closely with manufacturing sites in a site-facing role
Ability to operate effectively in a matrixed, global organization with shared accountabilities
Strong project leadership, stakeholder management, and communication skills
Ability to proactively identify and resolve complex technical and operational risks
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