Contract Development & Mfg Mgr at Amgen

India

<h2><b>Career Category</b></h2>Information Systems<h2></h2><h2><b>Job Description</b></h2><h1>HOW MIGHT YOU DEFY IMAGINATION?</h1><p>Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in innovative manufacturing capability and support services to deliver these therapies globally. Now we are hiring a Contract Development and Manufacturing Manager to support external manufacturing execution in India.</p><p></p><h1>Contract Development and Manufacturing Manager</h1><p></p><h2>What you will do</h2><p>The Amgen Contract Development and Manufacturing (ACDM) Organization is seeking a highly qualified candidate to work with Amgen’s external network of development and manufacturing partners to ensure uninterrupted clinical and commercial supply for Amgen’s 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.</p><p>The successful candidate will operate in a highly matrixed environment, driving cross-functional alignment and ensuring delivery across timelines, quality, and cost.</p><ul><li>Serve as program lead for external peptide manufacturing, accountable for end-to-end execution across development, clinical, and commercial stages</li><li>Act as a primary interface with CDMOs, working alongside the site lead to ensure alignment on program priorities and deliverables</li><li>Drive technology transfer, scale-up, and process readiness in collaboration with Process Development and site teams</li><li>Provide oversight of manufacturing activities to ensure readiness for GMP operations</li><li>Identify and manage program risks (technical, supply, regulatory) and drive mitigation strategies</li><li>Partner cross-functionally (Process Development, Analytical, Quality, Supply Chain, Regulatory) to ensure integrated execution</li><li>Support sourcing and externalization activities including Scope of Work (SoW) development and supplier engagement</li><li>Ensure adherence to cGMP requirements and Amgen business processes including deviations, change control, and investigations</li><li>Monitor and manage program performance across timeline, quality, and cost, escalating issues as needed</li><li>Present program updates, risks, and recommendations to senior management</li><li>Occasional domestic and international travel</li></ul><h1></h1><h1>Win</h1><h2>What we expect of you</h2><h3>Basic Qualifications</h3><p>Any degree with 8-13 years of experience</p><h3></h3><h3>Preferred Qualifications</h3><ul><li>Experience leading external manufacturing programs at CDMOs, preferably in peptides or related modalities</li><li>Demonstrated experience in technology transfer, scale-up, and GMP readiness</li><li>Strong understanding of drug substance development through commercial manufacturing</li><li>Experience working closely with manufacturing sites in a site-facing role</li><li>Ability to operate effectively in a matrixed, global organization with shared accountabilities</li><li>Strong project leadership, stakeholder management, and communication skills</li><li>Ability to proactively identify and resolve complex technical and operational risks</li></ul><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.