Process Development Senior Scientist

Amgen•Thousand Oaks, CA

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. The role focuses on biologics drug product formulation and co-formulation across modalities such as enzymes, monoclonal antibodies, and peptides, integrating formulation, analytical, and process data to guide product design and development. The successful candidate will apply scientific and engineering principles, advanced analytics, and emerging technologies—including AI and machine learning where appropriate—to develop stable, high-quality, manufacturable drug products and address technical challenges. The position also supports clinical and commercial technology transfer and manufacturing operations, contributes to regulatory submissions, and collaborates across functions in a fast-paced environment.

Requirements

Doctorate degree (PhD, PharmD, or MD), or a master’s degree and 3 years of scientific experience, or a bachelor’s degree and 5 years of scientific experience.
Strong understanding of protein attributes, stability, process-related degradation pathways, and analytical strategies for characterizing critical quality attributes.
Critical thinking, problem-solving, and independent research skills.
Strong project management skills, including managing project materials, workforce, and time.
Ability to work effectively in a fast-paced, matrixed environment and collaborate cross-functionally.
Strong communication skills.

Nice To Haves

PhD in Pharmaceutics, Biotechnology, Chemical Engineering, Bioengineering, Biochemistry, or a related field, with 2–4 years of postdoctoral or industry experience.
Experience integrating formulation, stability, and analytical data to advance biologics candidates, including enzymes, monoclonal antibodies, and peptides.
Demonstrated understanding of biologics drug product development, 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.
Experience with programming, AI-enabled tools, and data visualization tools such as Tableau or Spotfire.
Experience contributing to regulatory submissions such as CTAs and BLAs.

Responsibilities

Participate in Drug Product Commercialization Teams conducting pipeline product process development 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 biologics formulations, with particular emphasis on enzyme drug product formulations 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, and product impact assessments for process changes, improvements, and non-conformance investigations.
Stay current with industry and scientific developments to support continued 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.