Process Development Principal Scientist
Amgen
July 01, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Process Development Principal Scientist
Responsibilities:
- Lead all attribute and analytical aspects of a program in pivotal clinical process development while working cross-functionally within a Product development team
- Define analytical control strategies and implement methodologies for late-phase clinical programs, including analytical method development and optimization
- Lead method transfer and support cGMP manufacturing activities at internal and contract manufacturing/testing sites
- Author technical reports and CMC sections in regulatory documents; respond to analytical and product quality questions from health authorities
- Drive product characterization for process comparability studies, regulatory filings/questions, and reference standard qualification
- Provide expertise and evaluate Amgen platform/analytical technologies to drive innovation and efficiency
- Help define strategies to improve the effectiveness/efficiency of the Attribute Sciences department
- Maintain current analytical development knowledge (literature/technology) and apply it to evaluation/development of new methodologies
- Serve as a scientific resource and mentor junior staff
Basic Qualifications:
- PhD (or PharmD/MD) and 3 years relevant discipline/sub-discipline experience
OR Master’s degree and 6 years scientific experience
OR Bachelor’s degree and 8 years scientific experience
Preferred Qualifications / Skills:
- PhD with 3+ years industry experience
- Strong small-molecule analysis (chromatographic/spectroscopic), separation science, PAT, structure elucidation, solid-state characterization
- Analytical method development/testing for solid oral dosage, liquid/lyophilized formulations; dissolution method development
- GLP/GMP knowledge; method development/validation/transfer/remediation for in-process/release/stability
- Knowledge of major Pharmacopeia and ICH/FDA guidance (method transfer/validation, impurities, genotoxic impurities, early development)
- Technical transfer to non-GMP/GMP external contract organizations
- Multitask complex deliverables; strong leadership/problem solving/communication; cross-functional/global CMC teamwork
- Excellent technical writing and attention to detail for methods, specifications, reports, and regulatory filings
Benefits (explicitly stated):
- Health and welfare plans, retirement/savings, bonus (or sales incentive), stock-based long-term incentives, time-off, flexible work models where possible
Application instructions:
- Apply now via careers.amgen.com; no application deadline (accepted until sufficient number of candidates or selection).
Responsibilities:
- Lead all attribute and analytical aspects of a program in pivotal clinical process development while working cross-functionally within a Product development team
- Define analytical control strategies and implement methodologies for late-phase clinical programs, including analytical method development and optimization
- Lead method transfer and support cGMP manufacturing activities at internal and contract manufacturing/testing sites
- Author technical reports and CMC sections in regulatory documents; respond to analytical and product quality questions from health authorities
- Drive product characterization for process comparability studies, regulatory filings/questions, and reference standard qualification
- Provide expertise and evaluate Amgen platform/analytical technologies to drive innovation and efficiency
- Help define strategies to improve the effectiveness/efficiency of the Attribute Sciences department
- Maintain current analytical development knowledge (literature/technology) and apply it to evaluation/development of new methodologies
- Serve as a scientific resource and mentor junior staff
Basic Qualifications:
- PhD (or PharmD/MD) and 3 years relevant discipline/sub-discipline experience
OR Master’s degree and 6 years scientific experience
OR Bachelor’s degree and 8 years scientific experience
Preferred Qualifications / Skills:
- PhD with 3+ years industry experience
- Strong small-molecule analysis (chromatographic/spectroscopic), separation science, PAT, structure elucidation, solid-state characterization
- Analytical method development/testing for solid oral dosage, liquid/lyophilized formulations; dissolution method development
- GLP/GMP knowledge; method development/validation/transfer/remediation for in-process/release/stability
- Knowledge of major Pharmacopeia and ICH/FDA guidance (method transfer/validation, impurities, genotoxic impurities, early development)
- Technical transfer to non-GMP/GMP external contract organizations
- Multitask complex deliverables; strong leadership/problem solving/communication; cross-functional/global CMC teamwork
- Excellent technical writing and attention to detail for methods, specifications, reports, and regulatory filings
Benefits (explicitly stated):
- Health and welfare plans, retirement/savings, bonus (or sales incentive), stock-based long-term incentives, time-off, flexible work models where possible
Application instructions:
- Apply now via careers.amgen.com; no application deadline (accepted until sufficient number of candidates or selection).