Scientist/ Senior Engineer – Drug Product Process Engineering

Job title: Scientist/ Senior Engineer – Drug Product Process Engineering

About the Role In this vital role you will serve as Process Engineering Lead providing technical and project leadership for drug product formulation, fill/finish, inspection, and presentation-specific activities. This role will integrate process, product, manufacturing, quality, regulatory, and analytical information to ensure successful commercialization, robust lifecycle management, and reliable supply of assigned drug product SKUs. The role will support clinical and commercial manufacturing operations, technology transfers, new product introductions, process characterization, process optimization, and product impact assessments. The candidate will work closely with global cross-functional partners, including Process Development, Manufacturing, Quality, Regulatory, Attribute Sciences, Engineering, Supply Chain, and Commercial Operations. This position may support Amgen’s global drug product manufacturing network, including commercial sites, contract manufacturing partners, and internal development/manufacturing facilities. Domestic and international travel may be required.

What You'll Do

• Serve as the Drug Product SKU Lead for assigned commercial or late-stage pipeline products, providing end-to-end technical ownership for formulation, fill/finish, presentation, and lifecycle management activities.
• Lead or support commercial technology transfers, including facility-fit assessments, make-a-batch assessments, process gap analyses, risk assessments.

What We're Looking For

• Experience leading process engineering efforts for drug product formulation, fill/finish, and presentation.
• Ability to integrate information across process development, manufacturing, quality, regulatory, and analytics to enable commercialization and lifecycle management.
• Experience with technology transfers, process characterization, optimization, and product impact assessments; willingness to travel domestically and internationally.
• Strong cross-functional collaboration skills and ability to work with internal and external manufacturing networks.

Nice to Have

• Experience working with global drug product manufacturing networks, including contract manufacturers and internal development facilities.

Compensation & Benefits

• Salary range not disclosed in posting. Benefits not disclosed.