Process Development Principal Scientist

Role Summary

Lead technical and project efforts in drug product formulation development and fill/finish process development for Amgen’s late‑stage biologics. Based in Cambridge, MA, you will join the Pivotal Drug Product Technologies group and provide cross‑functional technical leadership to ensure successful commercialization. You will coordinate diverse teams to advance programs from development through lifecycle management.

Responsibilities

• Delivering progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs
• Authoring and reviewing guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions
• Driving continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering
• Serving as subject matter expert and help drive standard methodologies and technical advancements
• Serving as a Drug Product Team Lead of matrixed team to develop strategy in support of commercialization and life cycle management of Amgen’s pipeline
• Managing a team of engineers and scientists to advance program and functional objectives
• Expanding utilization of advanced IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis
• Working effectively in a highly matrixed team environment to influence and inspire change, efficiency, and foster positive relationships

Qualifications

• Required: Doctorate degree PhD OR PharmD OR MD and 2 years of Scientific experience OR Master’s degree and 5 years of Scientific experience OR Bachelor’s degree and 7 years Scientific experience
• Preferred: Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related subject area
• Preferred: 8+ years of experience in pharmaceuticals/biotechnology
• Preferred: 5+ years of experience that includes elements of formulation and fill/finish process development, process characterization, technical transfers to manufacturing sites, and statistical design and analysis of experiments, and regulatory authoring
• Preferred: Technical leader with demonstrated results driving forward programs
• Preferred: Experience in drug product regulatory strategy, RTQs, and agency engagement
• Preferred: Knowledge of, and hands-on experience with, bringing new biotech products to market, across various dosage forms and device delivery systems
• Preferred: Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), as well as data visualization tools (e.g. Tableau, Spotfire, D3js)
• Preferred: Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)
• Preferred: Experience participating and leading global multi-functional teams
• Preferred: Outstanding knowledge of formulation, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling, and the associated GMP/Device documentation and regulatory filings
• Preferred: Strong problem solving and effective multi-functional interpersonal skills
• Preferred: Willing and able to learn new technologies at a rapid pace

Additional Requirements

• Travel up to 10% of the time (domestic and international)