16 Aug
|
Amgen
|
Hyderabad
Contract Development and Manufacturing Manager
What you will do
The Amgen Contract Development and Manufacturing (ACDM) Organization is seeking a highly qualified candidate to work with Amgens external network of development and manufacturing partners to ensure uninterrupted clinical and commercial supply for Amgens portfolio. The position will be in the TIDES business unit of ACDM and will focus on the late-phase clinical and commercial peptide manufacturing. This is a key role in a high-performing cross-functional, global organization and will support external process development, supplier relationship management, and oversight of manufacturing activities.
The successful candidate will operate in a highly matrixed workplace, driving cross-functional alignment and ensuring delivery across timelines, quality, and cost.
- 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 i
📌 Contract Development (Hyderabad)
🏢 Amgen
📍 Hyderabad