Process Development Senior Scientist - Pivotal Drug Product Technologies

Process Development Senior Scientist – Pivotal Drug Product Technologies

In this vital role, you will work as a Process Development Senior Scientist within Pivotal Drug Product Technologies at Amgen’s Process Development hub in Cambridge, MA. This group is responsible for late‑stage drug product formulation and process development for biologics modalities (e.g., monoclonal antibodies, bispecific T‑cell engagers (BiTEs), and fusion proteins). Working closely with a team of scientists and engineers, the successful candidate will apply scientific and engineering principles to advance the technical aspects of Amgen’s drug product and process development.

• Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management.
• Design, plan, complete, and document formulation and process development studies.
• Apply scientific/engineering principles and techniques to develop, characterize and implement processes and next‑generation technologies and to solve technical challenges.
• Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions.
• Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root‑cause analysis, and product impact assessments for process changes/improvements and non‑conformance investigations.
• Author/review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
• Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs.
• Effectively and consistently communicate with management, cross‑functional partners and relevant team members on progress towards achievements and forthcoming program needs.
• Lead cross‑functional initiatives enhancing Pivotal Drug Product platforms.
• Manage and contribute to process design improvement projects.
• Ability to travel domestically and internationally up to 10% of the time.

We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek has:

• Doctorate degree OR
• Master’s degree and 3 years of scientific experience OR
• Bachelor’s degree and 5 years of scientific experience

• Advanced Degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Chemistry, Materials Science, Pharmaceutics or related field.
• Experience in pharmaceutical/biotechnology development and manufacturing.
• Experience in biologics process development, formulation development, fill‑finish process engineering, technical transfers to global manufacturing sites, and statistical design and analysis of experiments.
• Experience with development and characterization of formulations and drug product manufacturing processes.
• Experience with unit operation (e.g., filling, filtration, mixing, etc.) specific scale‑down model development, characterization, and scale‑up.
• Understanding of physical/chemical stability of proteins and how process‑related stress impacts product quality.
• Proficiency in at least one statistical software package (e.g., SAS, JMP or Minitab).
• Critical thinking, problem solving and independent research skills.
• Strong project management skills, including the ability to manage one’s project resources (material, workforce, time, etc.).
• Good organizational skills with strong attention to detail.
• Strong ability to operate well in a fast‑paced, matrixed environment and collaborate successfully cross‑functionally.

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a…