Associate Director, Commercial Drug Products & Life Cycle Management

Job title: Associate Director, Commercial Drug Products & Life Cycle Management

About the Role In Amgen’s Process Development organization, Drug Product Technologies unit, you will help deliver robust drug product manufacturing processes, high-quality CMC sections, and reliable supply of commercial products. As Associate Director, you will serve as the Drug Product Team Leader (DPTL) for commercial drug product programs, leading a scientific team responsible for formulation, aseptic drug product design and validation, lifecycle changes, regulatory submissions, and related activities to support commercialization and lifecycle management of parenteral and/or oral solid dosage products.

What You'll Do

• Lead commercial drug product programs as DPTL and mentor a scientific team supporting advancement of commercial drug product programs within Amgen's portfolio.
• Serve as a leader on Drug Product Commercialization Teams planning, designing, executing, and documenting laboratory studies related to drug product design, formulation, and process development in support of commercialization and lifecycle management of parenteral and/or oral solid dosage presentations.
• Lead a team of scientists focused on late-stage drug product process development and tech transfer to ensure robust, scalable manufacturing processes and timely regulatory submissions.
• Oversee process transfers, process optimization, troubleshooting, and timely closure of non-conformance investigations and change control assessments to ensure supply of commercial drug products.
• Collaborate cross-functionally with Regulatory, Manufacturing, Quality, and Supply Chain to prepare high-quality CMC sections and support annual product reviews, lifecycle changes, and regulatory submissions.
• Align with Amgen's mission and drive technical leadership within Drug Product Technologies and lifecycle management.

What We're Looking For

• Experience leading drug product development programs and managing cross-functional teams in a commercial/product lifecycle context.
• Expertise in formulation, aseptic drug product process design and validation, integrated development of combination products, process improvements, lifecycle changes, and regulatory submissions (CMC).
• Track record delivering drug product process transfers, tech transfer, lifecycle changes, and annual product reviews.
• Strong leadership, strategic thinking, and collaboration skills to operate across Regulatory, Manufacturing, Quality, and Supply Chain.