Process Development Senior Scientist
About The Position
Join Amgen’s Pivotal Drug Product Technologies group in Thousand Oaks, California. The group supports commercial drug product formulation development and formulation, fill, and finish process development for Amgen’s late-stage biologics portfolio. This role contributes to pipeline product process development, commercial product lifecycle management, and the development of high-quality, stable, and manufacturable drug products. The position calls for hands-on experience in biologics drug product formulation and co-formulation across modalities such as enzymes, monoclonal antibodies, and peptides. The scientist integrates formulation, analytical, and process data to guide product design and development, applying scientific and engineering principles, advanced statistical and data analytics, and AI or machine-learning technologies where appropriate. The role also supports technology transfer, manufacturing operations, regulatory submissions, and cross-functional initiatives in a fast-paced environment.
Requirements
- Doctorate degree (PhD, PharmD, or MD), with relevant postdoctoral experience where applicable; or a master’s degree and 3 years of scientific experience; or a bachelor’s degree and 5 years of scientific experience.
- Experience integrating formulation, stability, and analytical data to advance biologics candidates, including enzymes, monoclonal antibodies, and peptides.
- Understanding of biologics drug product development considerations, including protein stability, degradation pathways, quality attributes, and product/process comparability.
- Experience developing or characterizing enzymes, including assessing activity, stability, and performance under relevant formulation or process conditions.
- Experience in formulation and co-formulation development, fill-finish process engineering, technical transfers to global manufacturing sites, statistical process control, and statistical design and analysis of experiments.
- Foundation in analytical and biophysical techniques relevant to biologics, such as UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, and subvisible particle analysis.
- Programming experience and experience applying AI-enabled tools and data visualization tools such as Tableau or Spotfire.
- Communication skills and experience contributing to regulatory submissions such as CTAs and BLAs.
- Project management skills, including managing project resources such as materials, workforce, and time.
- Critical thinking, problem-solving, and independent research skills.
- Ability to work effectively in a fast-paced, matrixed environment and collaborate cross-functionally.
Nice To Haves
- PhD in Pharmaceutics, Biotechnology, Chemical Engineering, Bioengineering, Biochemistry, or a related field, with 2–4 years of postdoctoral or industry experience.
Responsibilities
- Participate in Drug Product Commercialization Teams conducting process development for pipeline products and supporting commercial products through lifecycle management.
- Design, plan, complete, 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 solve technical challenges.
- Use advanced statistical and data analytics techniques to draw conclusions and inform decisions.
- Develop and characterize liquid formulations for biologics, with particular emphasis on enzyme drug product formulation or co-formulations.
- Build process understanding across unit operations to support scalable drug product development.
- Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making.
- Author or review guideline documents, technical protocols and reports, risk assessments, and regulatory sections supporting IND and marketing application submissions.
- Support clinical and commercial technology transfer activities and manufacturing operations through process fit assessments, process capability analysis, troubleshooting, root cause analysis, product impact assessments, and non-conformance investigations.
- Stay current with developments in the industry and scientific community to support innovation and future business needs.
- Communicate progress, achievements, and forthcoming program needs to management, cross-functional partners, and relevant team members.
- Lead cross-functional initiatives to enhance drug product platforms and contribute to process design improvement projects.
Benefits
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
- Group medical, dental, and vision coverage.
- Life and disability insurance.
- Flexible spending accounts.
- Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.
- Career development opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
