Process Development Senior Scientist

Process Development Senior Scientist – Cambridge, MA

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. The group is responsible for late‑stage drug product formulation and process development for biologics modalities such as 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, execute, and document formulation and process development studies.
• Apply scientific and engineering principles and techniques to develop, characterize, and implement processes and next generation technologies and to solve technical challenges.
• Apply advanced digital data management and analytic techniques to mine and organize data (including text) to build quantitative models and qualitative descriptions that inform and support 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.
• Travel domestically and internationally up to 10% of the time.

• Doctorate Degree (PhD, Pharm
  
  D, or MD) with relevant post‑doctoral experience where applicable.
• Master's Degree and at least 3 years of scientific experience.
• Bachelor's Degree and at least 5 years of scientific experience.

• Advanced degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related subject area.
• Experience in pharmaceuticals/biotechnology or related field.
• Experience with artificial intelligence tools, coding/scripting for automated data analysis and modeling.
• Knowledge of, or experience with, formulation and commercial process development for liquid and lyophilized drug products.
• Experience with unit operation (e.g., filling, filtration, mixing, etc.) specific scale‑down model development, characterization, and scale‑up.
• Understanding of the physical/chemical stability of proteins and how process related stress impacts product quality.
• Experience with data visualization tools or packages, such as Tableau or Spotfire.
• Experience including elements of new product development, formulation development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiment.
• Critical thinking, problem solving and independent research skills.
• Strong project management skills, including the ability to lead a project’s resources (material, people, 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.

• Competitive base salary and a total rewards plan that includes health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities.
• A comprehensive employee benefits package, including a retirement and savings plan with generous company…