Scientist/ Senior Engineer – Drug Product Process Engineering
Amgen
June 25, 2026
Remote friendly (Thousand Oaks, CA)
United States
Operations
Scientist/ Senior Engineer – Drug Product Process Engineering
Responsibilities:
- Provide technical and project leadership for drug product formulation, fill/finish, inspection, and presentation-specific activities.
- Serve as Drug Product SKU Lead with end-to-end technical ownership for formulation, fill/finish, presentation, and lifecycle management.
- Lead/support commercial technology transfers (facility-fit, make-a-batch, gap analysis, risk assessment, characterization, documentation, on-site support).
- Lead parenteral drug product unit operations: formulation, mixing, sterile filtration, filling, capping, lyophilization, visual inspection.
- Plan/design/execute/document lab/offline/on-site studies for development, characterization, scale-up, robustness, and lifecycle management.
- Lead technical integration across process, quality attributes, manufacturing performance, analytical/regulatory commitments, and site capabilities.
- Support manufacturing via capability analysis, troubleshooting, RCA, non-conformance, CAPA, and product impact assessments.
- Author/review protocols, reports, transfer documents, regulatory responses, and lifecycle documentation.
Basic Qualifications:
- Doctorate degree; OR Master’s degree + 2 years experience; OR Bachelor’s degree + 4 years experience in Operations, Process Development, Scientific, or Engineering.
Preferred Qualifications (selected):
- M.S./Ph.D. in chemical/bio/pharma/related disciplines.
- 3+ years drug product process development/engineering/lifecycle management in pharma/biotech.
- Parenteral experience (liquid/lyophilized); fill/finish technical experience; aseptic processing/cGMP/ICH/GMP documentation.
- Statistical/process capability/DoE/risk assessment; data analysis and AI-enabled analytics.
Benefits (explicitly listed):
- Health/welfare plans, retirement/savings, bonus, stock long-term incentives, time-off, flexible work models (where possible).
Application Instructions:
- Apply now; no application deadline—applications accepted until sufficient candidates are received or selected.
Responsibilities:
- Provide technical and project leadership for drug product formulation, fill/finish, inspection, and presentation-specific activities.
- Serve as Drug Product SKU Lead with end-to-end technical ownership for formulation, fill/finish, presentation, and lifecycle management.
- Lead/support commercial technology transfers (facility-fit, make-a-batch, gap analysis, risk assessment, characterization, documentation, on-site support).
- Lead parenteral drug product unit operations: formulation, mixing, sterile filtration, filling, capping, lyophilization, visual inspection.
- Plan/design/execute/document lab/offline/on-site studies for development, characterization, scale-up, robustness, and lifecycle management.
- Lead technical integration across process, quality attributes, manufacturing performance, analytical/regulatory commitments, and site capabilities.
- Support manufacturing via capability analysis, troubleshooting, RCA, non-conformance, CAPA, and product impact assessments.
- Author/review protocols, reports, transfer documents, regulatory responses, and lifecycle documentation.
Basic Qualifications:
- Doctorate degree; OR Master’s degree + 2 years experience; OR Bachelor’s degree + 4 years experience in Operations, Process Development, Scientific, or Engineering.
Preferred Qualifications (selected):
- M.S./Ph.D. in chemical/bio/pharma/related disciplines.
- 3+ years drug product process development/engineering/lifecycle management in pharma/biotech.
- Parenteral experience (liquid/lyophilized); fill/finish technical experience; aseptic processing/cGMP/ICH/GMP documentation.
- Statistical/process capability/DoE/risk assessment; data analysis and AI-enabled analytics.
Benefits (explicitly listed):
- Health/welfare plans, retirement/savings, bonus, stock long-term incentives, time-off, flexible work models (where possible).
Application Instructions:
- Apply now; no application deadline—applications accepted until sufficient candidates are received or selected.