Lead Scientist, Process Development & Analytical Excellence

Biopharma Careers; Cambridge (MA); Hybrid; USD 142,000 - 192,000; Full time

Job summary

Amgen is seeking a Process Development Principal Scientist to lead analytical science across pivotal programs, shaping strategies for late-stage development. You will mentor teams, transfer methods, and ensure regulatory readiness while collaborating with Drug Substance, Drug Product, and Product Quality groups.

The role emphasizes scientific leadership, technical writing, and cross-functional delivery in a dynamic biopharma setting, with a focus on platform and process development for various

Qualifications

• Doctorate degree (PhD/PharmD/MD) with 3 years of relevant experience.
• Master's degree with 6 years of scientific experience.
• Bachelor's degree with 8 years of scientific experience.
• PhD with 3+ years of industry experience preferred.

Responsibilities

• Define analytical control strategies and develop methods for late-phase clinical programs.
• Lead attribute and analytical aspects of pivotal programs across multiple modalities.
• Perform method transfer and support cGMP manufacturing at internal and contract sites.
• Author technical reports and CMC sections for regulatory filings.

Skills

Leadership

Communication

Analytical thinking

Regulatory writing

Education

PhD/PharmD/MD

Master's degree

Bachelor's degree

Job description

Amgen is seeking a Process Development Principal Scientist to lead analytical science across pivotal programs, shaping strategies for late-stage development. You will mentor teams, transfer methods, and ensure regulatory readiness while collaborating with Drug Substance, Drug Product, and Product Quality groups.

The role emphasizes scientific leadership, technical writing, and cross-functional delivery in a dynamic biopharma setting, with a focus on platform and process development for various