Lead Process Development Scientist, Drug Product

BioSpace; Thousand Oaks (CA); On-site; USD 170,000 - 210,000; Full time

Benefits offered by this job

Stock-based incentives

Retirement and savings plan

Flexible work options

Job summary

Amgen is seeking a Process Development Principal Scientist to lead drug product development strategies and to design and run experiments supporting late-stage and commercial programs. You will guide cross-functional teams across formulation, process development, and regulatory activities, mentoring scientists along the way.

The role emphasizes strong organic chemistry expertise, collaboration across multiple disciplines, and robust technical writing skills, with a focus on oral solid dosage

Qualifications

• Doctorate degree (PhD/PharmD/MD) and 2+ years of scientific experience.
• Masters degree and 5+ years of scientific experience.
• Bachelors degree and 7+ years of scientific experience.
• Strong foundation in organic chemistry and related areas; publications and cross-functional collaboration valued.
• Experience mentoring and developing team members.

Responsibilities

• Develop innovative strategies for drug product development and perform DOE studies for late-stage and commercial programs.
• Lead Drug Product Teams as a DPTL and coordinate across Product Development Teams.
• Collaborate with Drug Substance Technologies, QA, Regulatory Affairs, and other functions to advance assets.
• Design, execute, and summarize experiments contributing to formulation and process development.
• Prepare technical documents, regulatory filings, and presentations with rigorous attention to detail.
• Engage with external groups and academic partners to advance projects.

Skills

Organic chemistry

Cross-functional collaboration

Scientific writing

Mentoring

Education

PhD/PharmD/MD

Masters degree

Bachelors degree

Tools

XRPD

DSC

TGA

SEM

Job description

Amgen is seeking a Process Development Principal Scientist to lead drug product development strategies and to design and run experiments supporting late-stage and commercial programs. You will guide cross-functional teams across formulation, process development, and regulatory activities, mentoring scientists along the way.

The role emphasizes strong organic chemistry expertise, collaboration across multiple disciplines, and robust technical writing skills, with a focus on oral solid dosage