Process Development Senior Scientist - Pre-Pivotal Drug Product Technologies
Amgen
August 31, 2026
Remote friendly (Thousand Oaks, CA)
United States
Operations
What You Will Do
- Collaborate in a fast-paced, matrixed environment across process development, research, regulatory, and manufacturing; communicate technical recommendations to peers and leadership.
- Plan and execute formulation and fill/finish studies for early-stage programs.
- Develop and characterize liquid and lyophilized biologic formulations, including handling and lab-scale sterile filling.
- Build process understanding across unit operations to support scalable drug product development.
- Evaluate in-use compatibility and drug product stability under clinical conditions.
- Investigate biologics-relevant CQAs (e.g., aggregation, fragmentation, charge/size variants, subvisible particles, surface interactions).
- Identify and address technology gaps affecting biologics stability, protein-excipient interactions, and process stress responses.
- Apply machine learning/AI, laboratory automation, and advanced data science for predictive modeling and workflow acceleration.
- Ensure development approaches are phase-appropriate from discovery through clinical manufacturing.
- Author technical documents, control-strategy inputs, risk assessments, IND/CTA sections, and tech transfer packages.
- Support technology transfer with CMOs/CDMOs (batch record review, process fit assessments, person-in-plant support, troubleshooting).
- Present findings to stakeholders and participate in cross-functional teams.
What We Expect Of You
Basic Qualifications:
- PhD OR PharmD OR MD
- OR Master’s degree + 3 years scientific experience
- OR Bachelor’s degree + 5 years scientific experience
Preferred Qualifications:
- PhD in Pharmaceutics/Biotechnology/Biochemistry (2–4 years postdoc/industry)
- Biologics formulation development, stability testing, and fill/finish experience (direct experience strongly preferred)
- Understanding of protein degradation, quality attributes, and product/process comparability
- Experience integrating formulation/stability/analytical data toward clinical manufacturing
- Laboratory automation/workflow digitization; AI/ML (e.g., LLMs/in silico); electronic data capture
- Analytical/biophysical techniques (e.g., UPLC/HPLC, SEC, IEX, HIC, CE-SDS, subvisible particles)
- Clinical-stage development, manufacturability, and risk-based decision-making
- Regulatory submission experience (CTAs, BLAs)
Benefits (explicitly listed)
- Retirement and Savings Plan; group medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus (or sales incentive for field); stock-based long-term incentives; time-off; flexible work models (where possible).
Application Instructions
- Apply via careers.amgen.com; no application deadline (accepting until sufficient applicants or selection).
- Collaborate in a fast-paced, matrixed environment across process development, research, regulatory, and manufacturing; communicate technical recommendations to peers and leadership.
- Plan and execute formulation and fill/finish studies for early-stage programs.
- Develop and characterize liquid and lyophilized biologic formulations, including handling and lab-scale sterile filling.
- Build process understanding across unit operations to support scalable drug product development.
- Evaluate in-use compatibility and drug product stability under clinical conditions.
- Investigate biologics-relevant CQAs (e.g., aggregation, fragmentation, charge/size variants, subvisible particles, surface interactions).
- Identify and address technology gaps affecting biologics stability, protein-excipient interactions, and process stress responses.
- Apply machine learning/AI, laboratory automation, and advanced data science for predictive modeling and workflow acceleration.
- Ensure development approaches are phase-appropriate from discovery through clinical manufacturing.
- Author technical documents, control-strategy inputs, risk assessments, IND/CTA sections, and tech transfer packages.
- Support technology transfer with CMOs/CDMOs (batch record review, process fit assessments, person-in-plant support, troubleshooting).
- Present findings to stakeholders and participate in cross-functional teams.
What We Expect Of You
Basic Qualifications:
- PhD OR PharmD OR MD
- OR Master’s degree + 3 years scientific experience
- OR Bachelor’s degree + 5 years scientific experience
Preferred Qualifications:
- PhD in Pharmaceutics/Biotechnology/Biochemistry (2–4 years postdoc/industry)
- Biologics formulation development, stability testing, and fill/finish experience (direct experience strongly preferred)
- Understanding of protein degradation, quality attributes, and product/process comparability
- Experience integrating formulation/stability/analytical data toward clinical manufacturing
- Laboratory automation/workflow digitization; AI/ML (e.g., LLMs/in silico); electronic data capture
- Analytical/biophysical techniques (e.g., UPLC/HPLC, SEC, IEX, HIC, CE-SDS, subvisible particles)
- Clinical-stage development, manufacturability, and risk-based decision-making
- Regulatory submission experience (CTAs, BLAs)
Benefits (explicitly listed)
- Retirement and Savings Plan; group medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus (or sales incentive for field); stock-based long-term incentives; time-off; flexible work models (where possible).
Application Instructions
- Apply via careers.amgen.com; no application deadline (accepting until sufficient applicants or selection).