Lead Process Development Scientist - Analytical Leadership

Amgen; Cambridge (MA); On-site; USD 142,000 - 192,000; Full time

Job summary

Amgen Inc. in Cambridge, MA seeks a Process Development Principal Scientist to lead analytical efforts across late‑phase development. You will define strategies, develop robust methods, and drive cross‑functional collaboration with Drug Substance, Drug Product and Product Quality teams.

You will author CMC sections, support regulatory filings, and mentor junior staff while advancing cutting‑edge analytical technologies in a global setting.

Qualifications

• Doctorate or professional degree with post-doc experience preferred.
• Strong leadership and ability to mentor junior staff.
• Excellent technical writing for methods and regulatory documents.

Responsibilities

• Define analytical control strategies and develop late‑phase methods.
• Lead method transfer and support GMP manufacturing activities.
• Author CMC sections in regulatory filings and reports.
• Drive product characterization for regulatory filings and questions.
• Mentor and lead Attribute Sciences teams across functions.

Skills

Leadership

Problem solving

Decision making

Communication skills

Technical writing

Education

PhD / PharmD / MD

Master's degree

Bachelor's degree

Tools

cGMP knowledge

Analytical method development

Job description

Amgen Inc. in Cambridge, MA seeks a Process Development Principal Scientist to lead analytical efforts across late‑phase development. You will define strategies, develop robust methods, and drive cross‑functional collaboration with Drug Substance, Drug Product and Product Quality teams.

You will author CMC sections, support regulatory filings, and mentor junior staff while advancing cutting‑edge analytical technologies in a global setting.