Scientist​/Senior Engineer – Drug Product Process Engineering

What you will do

Let’s do this. Let’s change the world. 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.

Scientist/ Senior Engineer – Drug Product Process Engineering

Responsibilities:

• 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, process characterization studies, technical documentation, and on-site manufacturing support.
• Act as a Process Engineering Lead for parenteral drug product unit operations, including formulation, mixing, sterile filtration, filling, capping, lyophilization, visual inspection, and related equipment/process interfaces.
• Plan, design, execute, and document laboratory, offline, and on-site studies related to drug product process development, process characterization, scale-up, process robustness, and lifecycle management.
• Provide technical leadership for assigned SKUs by integrating process understanding, product quality attributes, manufacturing performance, analytical data, regulatory commitments, and site capabilities.
• Support clinical and commercial manufacturing operations through process capability analysis, troubleshooting, root cause analysis, non-conformance investigations, corrective and preventive actions, and product impact assessments.
• Author and review technical protocols, study reports, process transfer documents, product impact assessments, regulatory submission sections, responses to regulatory questions, and lifecycle management documentation.
• Partner with manufacturing sites and cross-functional teams to assess and implement process changes, equipment changes, raw material changes, scale changes, site transfers, and process improvements while ensuring product quality and supply continuity.
• Apply scientific and engineering principles, including biochemistry, biophysics, statistics, chemical engineering, mechanical engineering, automation, and equipment design, to solve complex technical challenges.
• Use data-driven approaches, statistical analysis, process monitoring, modeling, and advanced digital or AI-enabled tools to improve process understanding, manufacturing robustness, and technology transfer efficiency.
• Lead or participate in global cross-functional teams in a highly matrixed environment, influencing decision-making, communicating risks, and driving alignment across stakeholders.
• Deliver clear technical updates, progress reports, risk assessments, and recommendations to management, program teams, governance forums, and manufacturing partners.
• Build and sustain strong partnerships with Drug Product Technologies, Attribute Sciences, Manufacturing, Quality, Regulatory, Engineering, Supply Chain, and site teams to ensure alignment between product needs, process requirements, and site capabilities.

We are all different, yet we all use our unique contributions to serve patients. The Scientific professional we seek is an…