Senior Process Development Scientist — Biologics & Automation

Amgen; Thousand Oaks (CA); Hybrid; USD 120,000 - 190,000; Full time

Job summary

Amgen, Thousand Oaks, CA, is seeking a Process Development Sr Scientist to join the Pre-Pivotal Drug Product Technologies group, focusing on early-stage biologics formulation, CQAs, and robust fill/finish processes.

You will work cross-functionally, apply DoE, automate workflows, and contribute to regulatory submissions and tech transfers. A PhD/MD/PharmD or MS with relevant experience is required, with emphasis on automation and data-driven decision making.

Qualifications

• PhD/MD/PharmD or equivalent required with scientific experience.
• Strong formulation development and stability testing experience with biologics.
• Experience with high-throughput formulation and automated workflows.
• Regulatory submissions experience a plus; DoE and DoE in DoE use.

Responsibilities

• Design and develop liquid and lyophilized biologics formulations.
• Plan DoE-driven formulation and fill/finish studies for early programs.
• Develop scalable drug product processes and case studies.
• Build cross-functional collaboration to advance programs.
• Implement laboratory automation and high-throughput screening.
• Prepare regulatory documents and tech transfer packages.

Skills

DoE

Communication skills

Automation experience

AI/ML experience

Education

PhD/MD/PharmD

Master's degree

Bachelor's degree

Tools

Hamilton

Tecan

Beckman Coulter

Opentrons

Job description

Amgen, Thousand Oaks, CA, is seeking a Process Development Sr Scientist to join the Pre-Pivotal Drug Product Technologies group, focusing on early-stage biologics formulation, CQAs, and robust fill/finish processes.

You will work cross-functionally, apply DoE, automate workflows, and contribute to regulatory submissions and tech transfers. A PhD/MD/PharmD or MS with relevant experience is required, with emphasis on automation and data-driven decision making.