Process Development Principal Scientist – Drug Product Technologies
Amgen
August 15, 2026
Remote friendly (Thousand Oaks, CA)
United States
Operations
Process Development Principal Scientist
What You Will Do
- Lead drug product team activities: plan, design, execute, and document lab studies for drug product design, formulation, process development, technology transfer, and regulatory authoring.
- Collaborate in a fast-paced, matrixed environment across process development, research, analytical, regulatory, quality, manufacturing, and external partners; influence strategies and communicate technical recommendations.
- Develop and characterize liquid and lyophilized formulations for complex biologics (ADCs, oligonucleotides/siRNAs, monoclonal antibodies, multispecifics).
- Build process understanding across unit operations; evaluate in-use compatibility and stability under clinically relevant conditions.
- Investigate CQAs (aggregation, fragmentation, charge/size variants, subvisible particles, surface interactions, concentration-dependent behavior) including modality-specific attributes (drug-to-antibody ratio, free payload/impurities, linker-payload integrity, purity/degradation).
- Use high-throughput/data-driven tools; identify and address technology gaps affecting stability and manufacturability.
- Apply ML/AI, automation, and data science for predictive modeling, workflow acceleration, data integration, and decision-making.
- Drive continuous improvement; ensure phase-appropriate approaches from discovery through clinical manufacturing.
- Serve as SME; provide technical guidance/mentorship.
- Author/review technical documents, reports, control strategy inputs, risk assessments, IND/CTA sections, and technology transfer packages; support technology transfers and CMO/CDMO activities.
Basic Qualifications
- Doctorate degree
- OR Master’s + 2 years scientific experience
- OR Bachelor’s + 4 years scientific experience
Preferred Qualifications
- PhD in relevant fields with 3+ years industry experience.
- Strong biologics drug product formulation/process development/fill-finish experience; ADC and/or oligonucleotide/siRNA experience.
- Experience with stability/degradation, aggregation/particulates, manufacturability, comparability, phase-appropriate control strategies.
- Strong analytical/biophysical foundation (e.g., UPLC/HPLC, SEC, IEX, CE-SDS, LC-MS, subvisible particles, viscosity, osmolality, stability-indicating methods).
- Familiarity with clinical-stage development, manufacturability, technology transfer, risk-based decision-making.
- Experience applying AI/ML and data science; strong technical report/regulatory submission experience (IND/CTA/BLA or equivalent).
Application Instructions
- Apply now via careers.amgen.com. No application deadline; continue accepting until a sufficient number of applications are received or a candidate is selected.
What You Will Do
- Lead drug product team activities: plan, design, execute, and document lab studies for drug product design, formulation, process development, technology transfer, and regulatory authoring.
- Collaborate in a fast-paced, matrixed environment across process development, research, analytical, regulatory, quality, manufacturing, and external partners; influence strategies and communicate technical recommendations.
- Develop and characterize liquid and lyophilized formulations for complex biologics (ADCs, oligonucleotides/siRNAs, monoclonal antibodies, multispecifics).
- Build process understanding across unit operations; evaluate in-use compatibility and stability under clinically relevant conditions.
- Investigate CQAs (aggregation, fragmentation, charge/size variants, subvisible particles, surface interactions, concentration-dependent behavior) including modality-specific attributes (drug-to-antibody ratio, free payload/impurities, linker-payload integrity, purity/degradation).
- Use high-throughput/data-driven tools; identify and address technology gaps affecting stability and manufacturability.
- Apply ML/AI, automation, and data science for predictive modeling, workflow acceleration, data integration, and decision-making.
- Drive continuous improvement; ensure phase-appropriate approaches from discovery through clinical manufacturing.
- Serve as SME; provide technical guidance/mentorship.
- Author/review technical documents, reports, control strategy inputs, risk assessments, IND/CTA sections, and technology transfer packages; support technology transfers and CMO/CDMO activities.
Basic Qualifications
- Doctorate degree
- OR Master’s + 2 years scientific experience
- OR Bachelor’s + 4 years scientific experience
Preferred Qualifications
- PhD in relevant fields with 3+ years industry experience.
- Strong biologics drug product formulation/process development/fill-finish experience; ADC and/or oligonucleotide/siRNA experience.
- Experience with stability/degradation, aggregation/particulates, manufacturability, comparability, phase-appropriate control strategies.
- Strong analytical/biophysical foundation (e.g., UPLC/HPLC, SEC, IEX, CE-SDS, LC-MS, subvisible particles, viscosity, osmolality, stability-indicating methods).
- Familiarity with clinical-stage development, manufacturability, technology transfer, risk-based decision-making.
- Experience applying AI/ML and data science; strong technical report/regulatory submission experience (IND/CTA/BLA or equivalent).
Application Instructions
- Apply now via careers.amgen.com. No application deadline; continue accepting until a sufficient number of applications are received or a candidate is selected.