Process Development Senior Scientist - Pre-Pivotal Drug Product Technologies
Amgen
August 13, 2026
Remote friendly (Thousand Oaks, CA)
United States
Operations
Process Development Sr Scientist
What You Will Do
- Join Pre-Pivotal Drug Product Technologies to lead early-stage drug product development (monoclonal antibodies, multispecifics, other biologic modalities).
- Design/develop liquid and lyophilized formulations; evaluate critical quality attributes (CQAs).
- Establish robust, scalable fill/finish processes for complex biologic drug products.
- Author/support regulatory submissions (IND/CTA sections) and control-strategy/risk documentation.
- Plan and execute formulation and fill/finish studies; develop/characterize liquid and lyophilized biologic formulations (including lab-scale sterile filling).
- Build unit-operation process understanding; assess in-use compatibility and clinical-condition stability.
- Investigate biologics-relevant CQAs (aggregation, fragmentation, charge/size variants, subvisible particles, surface interactions).
- Create and run automated high-throughput formulation screening and lab automation (robotic liquid handling, automated sample prep) to improve throughput, reproducibility, and data quality.
- Use DoE, high-throughput experimentation, automated data analysis, and AI/ML for predictive modeling and decision-making.
- Support technology transfer (CMOs/CDMOs, batch record review, process fit, person-in-plant support, troubleshooting) and present findings in cross-functional teams.
What We Expect Of You
Basic Qualifications
- PhD/Doctorate (PhD, 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)
- Direct biologics drug product formulation experience; biologics stability and fill/finish experience
- Experience integrating formulation/stability/analytical data into clinical manufacturing
- Hands-on high-throughput formulation development with automated liquid handling/robotic workflows
- DoE/high-throughput experimentation, lab robotics, workflow orchestration
- Analytical/biophysical techniques (e.g., HPLC/UPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis)
- Clinical-stage development/manufacturability and risk-based decision-making
- AI/ML experience (e.g., LLMs, in silico tools); regulatory submission experience (CTAs/BLAs)
Benefits (Total Rewards Plan, eligibility-based)
- Retirement and Savings Plan; medical/dental/vision; life/disability; flexible spending accounts
- Discretionary annual bonus (or sales incentive for field roles)
- Stock-based long-term incentives; award-winning time-off; flexible work models (when possible)
Application Instructions
- Apply via careers.amgen.com; no application deadline (applications continue until sufficient candidates are received or a candidate is selected).
What You Will Do
- Join Pre-Pivotal Drug Product Technologies to lead early-stage drug product development (monoclonal antibodies, multispecifics, other biologic modalities).
- Design/develop liquid and lyophilized formulations; evaluate critical quality attributes (CQAs).
- Establish robust, scalable fill/finish processes for complex biologic drug products.
- Author/support regulatory submissions (IND/CTA sections) and control-strategy/risk documentation.
- Plan and execute formulation and fill/finish studies; develop/characterize liquid and lyophilized biologic formulations (including lab-scale sterile filling).
- Build unit-operation process understanding; assess in-use compatibility and clinical-condition stability.
- Investigate biologics-relevant CQAs (aggregation, fragmentation, charge/size variants, subvisible particles, surface interactions).
- Create and run automated high-throughput formulation screening and lab automation (robotic liquid handling, automated sample prep) to improve throughput, reproducibility, and data quality.
- Use DoE, high-throughput experimentation, automated data analysis, and AI/ML for predictive modeling and decision-making.
- Support technology transfer (CMOs/CDMOs, batch record review, process fit, person-in-plant support, troubleshooting) and present findings in cross-functional teams.
What We Expect Of You
Basic Qualifications
- PhD/Doctorate (PhD, 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)
- Direct biologics drug product formulation experience; biologics stability and fill/finish experience
- Experience integrating formulation/stability/analytical data into clinical manufacturing
- Hands-on high-throughput formulation development with automated liquid handling/robotic workflows
- DoE/high-throughput experimentation, lab robotics, workflow orchestration
- Analytical/biophysical techniques (e.g., HPLC/UPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis)
- Clinical-stage development/manufacturability and risk-based decision-making
- AI/ML experience (e.g., LLMs, in silico tools); regulatory submission experience (CTAs/BLAs)
Benefits (Total Rewards Plan, eligibility-based)
- Retirement and Savings Plan; medical/dental/vision; life/disability; flexible spending accounts
- Discretionary annual bonus (or sales incentive for field roles)
- Stock-based long-term incentives; award-winning time-off; flexible work models (when possible)
Application Instructions
- Apply via careers.amgen.com; no application deadline (applications continue until sufficient candidates are received or a candidate is selected).