Lead Analytical Scientist, Oligonucleotide Process Development

Amgen Inc. (IR); Thousand Oaks (CA); On-site; USD 158,000 - 213,000; Full time

Job summary

Amgen Inc. in Thousand Oaks seeks a Process Development Senior Principal Scientist to lead analytical scientists in developing, transferring, validating, and implementing analytical methods for late‑phase oligonucleotide programs through commercialization.

You will provide scientific and strategic leadership, shaping control strategies and enabling process understanding to support PPQ, regulatory submissions, and commercial launch.

Qualifications

• PhD, PharmD, or MD plus 2+ years scientific experience.
• MS with 5+ years scientific experience.
• BS with 7+ years scientific experience.

Responsibilities

• Lead analytical method development for late-phase oligonucleotide programs.
• Provide scientific and strategic leadership as ASTL.
• Oversee method transfer/validation for development, release, and stability testing.
• Collaborate with PD, Manufacturing, QA, Regulatory, and external partners.
• Define analytical control strategies for late-phase programs.
• Prepare concise summaries for cross-functional leadership and regulatory filings.
• Oversee activities at contract manufacturing/testing sites.
• Author CMC sections in regulatory documents and respond to health authority inquiries.

Skills

Analytical chemistry

Mass spectrometry

Team leadership

Regulatory knowledge

Cross-functional collaboration

Technical writing

Education

PhD/MD/PharmD

MS +5 years

BS +7 years

Job description

Amgen Inc. in Thousand Oaks seeks a Process Development Senior Principal Scientist to lead analytical scientists in developing, transferring, validating, and implementing analytical methods for late‑phase oligonucleotide programs through commercialization.

You will provide scientific and strategic leadership, shaping control strategies and enabling process understanding to support PPQ, regulatory submissions, and commercial launch.