Principal Process Development Scientist – Drug Product Leader

Amgen; Thousand Oaks (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Amgen seeks a Process Development Principal Scientist to advance late-stage and commercial drug product development. You will design and execute DOE studies, lead cross-functional Drug Product Teams, and provide technical expertise on materials and formulations.

You will mentor scientists, summarize results for regulatory filings, and collaborate with colleagues across Drug Substance Technologies, QA, Regulatory Affairs, and manufacturing to ensure robust, scalable processes.

Qualifications

• PhD/PharmD/MD with 2+ years of scientific experience or Master’s with 5+ years or Bachelor’s with 7+ years.
• Strong foundation in organic chemistry, physical chemistry, and materials science.
• Experience with oral solid dosage form development and regulatory interactions.

Responsibilities

• Develop innovative strategies for drug product development and DOE studies.
• Lead Drug Product Teams as a DPTL and collaborate across Amgen functions.
• Design, execute, and summarize experiments to support late-stage assets and commercial development.
• Mentor and supervise scientists within the team.
• Prepare technical documents, regulatory filings, and presentations.

Skills

Organic Chemistry

Physical Chemistry

Solid-state Chemistry

Formulation Science

Scientific Writing

Mentoring

Education

PhD

PharmD

MD

Master's degree in Chemistry/Pharm/Sci

Bachelor's degree in a science

Tools

XRPD

DSC

TGA

SEM

Job description

Amgen seeks a Process Development Principal Scientist to advance late-stage and commercial drug product development. You will design and execute DOE studies, lead cross-functional Drug Product Teams, and provide technical expertise on materials and formulations.

You will mentor scientists, summarize results for regulatory filings, and collaborate with colleagues across Drug Substance Technologies, QA, Regulatory Affairs, and manufacturing to ensure robust, scalable processes.