Lead Process Development Scientist, Attribute Sciences

BioSpace; Cambridge (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

Amgen is seeking a Process Development Principal Scientist to lead analytical and regulatory efforts within the Attribute Sciences department, guiding development and commercialization of robust manufacturing processes for complex therapeutics.

The role emphasizes strategic analytical leadership across teams and collaboration with Drug Substance, Drug Product, and Product Quality to support regulatory filings.

Qualifications

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

Responsibilities

• Lead all attribute and analytical aspects of a program in pivotal clinical process development.
• Define analytical control strategies and methods for late-phase programs.
• Lead method transfer and support cGMP manufacturing activities.
• Author CMC sections in regulatory documents and respond to health authorities questions.
• Drive product characterization for regulatory filings and standards.
• Provide expertise in analytical technologies and drive innovation within Process Development.
• Mentor junior staff and develop team capabilities.
• Help define strategies to improve department effectiveness.

Skills

Analytical leadership

Regulatory writing

Method development

cGMP knowledge

Team leadership

Cross-functional collaboration

Education

PhD/PharmD/MD

Master's degree

Bachelor's degree

Tools

Chromatography

Spectroscopy

Analytical method transfer

QA documentation tools

Job description

Amgen is seeking a Process Development Principal Scientist to lead analytical and regulatory efforts within the Attribute Sciences department, guiding development and commercialization of robust manufacturing processes for complex therapeutics.

The role emphasizes strategic analytical leadership across teams and collaboration with Drug Substance, Drug Product, and Product Quality to support regulatory filings.