Process Development Sr Principal Scientist

Process Development Sr Principal Scientist

In this vital role within Amgen's Commercial Drug Product Technologies group, you will be responsible for process development and lifecycle management of commercial drug product formulation and fill/finish processes across various modalities. You will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the commercialization and life‑cycle of the products.

Serve as a leader on Drug Product Commercialization Teams responsible for planning, designing, executing, and documenting laboratory studies related to drug product design, formulation, and process development in support of commercialization and lifecycle management of biologic drug product presentations.

• 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 non‑conformance investigations and process changes/improvements.
• Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.
• Participate and lead global cross‑functional teams working effectively in a highly matrixed team environment to influence and inspire change, efficiency, and cultivate strong relationships.
• Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions.
• Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.
• Actively utilize advanced IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis.
• Ability to travel domestically and internationally up to 10% of the time.

• Doctorate degree (PhD OR Pharm
  
  D OR MD) and 3 years of scientific experience
• Masters degree and 6 years of scientific experience
• Bachelors degree and 8 years of scientific experience

• Advanced degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related subject area
• 5+ years of post‑doctoral or industry experience in pharmaceuticals/biotechnology or related field
• Knowledge of/hands‑on experience with end‑to‑end development for liquid, lyophilized and/or oral solid dosage drug products in various presentations
• Knowledge and awareness of the regulations governing combination product development
• Experience with parenteral biologics (i.e. filling, filtration, mixing, etc.) process characterization, scale‑up, and commercial manufacturing
• Understanding of physical/chemical stability of proteins and how process‑related stress impacts product quality, specifically, the impact of freezing and drying to short‑ and long‑term stability
• Aseptic processing experience and familiarity with cGMPs, ICH guidelines, and pre‑approval inspection/audits
• Experience that includes elements of new product development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
• Strong problem solving and effective interpersonal skills, and the ability to influence colleagues with ideas
• Previous scientific and managerial experience in support of drug product development, investigations, and regulatory filings is important
• Ability to learn and rapidly react in an environment with dynamic information

Amgen offers a competitive benefits package and career development opportunities to support your professional growth. In addition to the base salary, the total rewards plan includes health and welfare plans, financial plans for retirement, work/life balance initiatives, flexible work models where possible, and stock‑based long‑term incentives.

• A comprehensive employee benefits package, including a retirement and savings plan with generous company…