Process Development Senior Scientist - Drug Product Technologies
Amgen
9 hours ago
Remote friendly (Thousand Oaks, CA)
United States
Operations
Process Development Senior Scientist - Drug Product Technologies
Responsibilities:
- Join Pre-Pivotal Drug Product Technologies group for early-stage drug product development with strong emphasis on ADCs, plus monoclonal antibodies, multispecifics, and other biologic modalities.
- Design and develop liquid and lyophilized formulations; evaluate critical quality attributes (CQAs); establish robust, scalable fill/finish processes.
- Plan and execute formulation and fill/finish studies; develop and characterize formulations with focus on ADCs, handling, and lab-scale sterile filling.
- Build process understanding across unit operations; evaluate in-use compatibility and clinical-condition stability.
- Investigate ADC/biologics-relevant CQAs (e.g., aggregation, fragmentation, drug-to-antibody ratio, free payload, charge/size variants, subvisible particles, surface interactions).
- Use high-throughput tools for screening and processability assessments.
- Identify/address technology gaps affecting ADC stability, linker-payload integrity, protein-excipient interactions, and process stress responses.
- Apply ML/AI/data science for predictive modeling and decision-making.
- Author technical documents, control-strategy inputs, risk assessments, IND/CTA sections, and tech transfer packages.
- Support technology transfer with CMOs/CDMOs and troubleshoot during manufacturing campaigns; present findings cross-functionally.
Qualifications:
- Basic: PhD (or PharmD/MD with relevant post-doc) OR Master’s + 3 years scientific experience OR Bachelor’s + 5 years scientific experience.
- Preferred: 2–4 years postdoc/industry; formulation development/stability/fill-finish for biologics with direct ADC drug product experience.
- Strong ADC knowledge (linker-payload stability, DAR, degradation, CQAs/comparability) and analytical/biophysical foundation (e.g., UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particles).
- Familiarity with clinical-stage development/manufacturability and risk-based decision-making.
- AI/ML experience (e.g., LLMs, in silico tools); experience with regulatory submissions (CTAs/BLAs).
Benefits:
- Total Rewards Plan (eligibility-based): comprehensive benefits including retirement/savings, medical/dental/vision, life/disability, flexible spending; discretionary annual bonus; stock-based long-term incentives; time-off; flexible work models where possible.
Application instructions:
- Apply via careers.amgen.com; no application deadline (applications accepted until sufficient number or selection); sponsorship not guaranteed.
Responsibilities:
- Join Pre-Pivotal Drug Product Technologies group for early-stage drug product development with strong emphasis on ADCs, plus monoclonal antibodies, multispecifics, and other biologic modalities.
- Design and develop liquid and lyophilized formulations; evaluate critical quality attributes (CQAs); establish robust, scalable fill/finish processes.
- Plan and execute formulation and fill/finish studies; develop and characterize formulations with focus on ADCs, handling, and lab-scale sterile filling.
- Build process understanding across unit operations; evaluate in-use compatibility and clinical-condition stability.
- Investigate ADC/biologics-relevant CQAs (e.g., aggregation, fragmentation, drug-to-antibody ratio, free payload, charge/size variants, subvisible particles, surface interactions).
- Use high-throughput tools for screening and processability assessments.
- Identify/address technology gaps affecting ADC stability, linker-payload integrity, protein-excipient interactions, and process stress responses.
- Apply ML/AI/data science for predictive modeling and decision-making.
- Author technical documents, control-strategy inputs, risk assessments, IND/CTA sections, and tech transfer packages.
- Support technology transfer with CMOs/CDMOs and troubleshoot during manufacturing campaigns; present findings cross-functionally.
Qualifications:
- Basic: PhD (or PharmD/MD with relevant post-doc) OR Master’s + 3 years scientific experience OR Bachelor’s + 5 years scientific experience.
- Preferred: 2–4 years postdoc/industry; formulation development/stability/fill-finish for biologics with direct ADC drug product experience.
- Strong ADC knowledge (linker-payload stability, DAR, degradation, CQAs/comparability) and analytical/biophysical foundation (e.g., UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particles).
- Familiarity with clinical-stage development/manufacturability and risk-based decision-making.
- AI/ML experience (e.g., LLMs, in silico tools); experience with regulatory submissions (CTAs/BLAs).
Benefits:
- Total Rewards Plan (eligibility-based): comprehensive benefits including retirement/savings, medical/dental/vision, life/disability, flexible spending; discretionary annual bonus; stock-based long-term incentives; time-off; flexible work models where possible.
Application instructions:
- Apply via careers.amgen.com; no application deadline (applications accepted until sufficient number or selection); sponsorship not guaranteed.