Principal Scientist, Process Development — Attribute Sciences

BioSpace; Cambridge (MA); On-site; USD 180,000 - 230,000; Full time

Job summary

Amgen, a leader in biotechnology, seeks a Process Development Principal Scientist to guide analytical strategies within Attribute Sciences. You will lead method development, control strategies, and regulatory documentation, collaborating with Drug Substance, Drug Product, and Product Quality teams to drive robust manufacturing processes.

You will mentor junior staff, oversee method transfer, and support regulatory filings across pivotal clinical programs in a global setting.

Qualifications

• PhD, PharmD, or MD with relevant post-doc experience.
• Master's degree with 6+ years of scientific experience.
• Bachelor's degree with 8+ years of scientific experience.

Responsibilities

• Lead analytical strategies for pivotal clinical programs and collaborate with cross-functional teams.
• Define analytical control strategies for late-phase development and method transfer.
• Author CMC sections and regulatory documents; respond to health authority questions.
• Support manufacturing activities at internal and contract sites; drive process characterization.

Skills

Analytical leadership

Analytical method development

Regulatory writing

Cross-functional collaboration

GMP/GLP knowledge

Project management

Education

PhD/PharmD/MD with post-doc experience

Master's degree with 6+ years of experience

Bachelor's degree with 8+ years of experience

Tools

HPLC/LC

Spectroscopy techniques

Job description

Amgen, a leader in biotechnology, seeks a Process Development Principal Scientist to guide analytical strategies within Attribute Sciences. You will lead method development, control strategies, and regulatory documentation, collaborating with Drug Substance, Drug Product, and Product Quality teams to drive robust manufacturing processes.

You will mentor junior staff, oversee method transfer, and support regulatory filings across pivotal clinical programs in a global setting.