Scientist​/Senior Engineer - Drug Product Process Engineering

Position: Scientist/ Senior Engineer - Drug Product Process Engineering
** Join Amgen's Mission of Serving Patients*
* At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas
-Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

** 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.

** 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…