Senior Biologics Process Development Scientist

Biopharma Careers; Thousand Oaks (CA); On-site; USD 126,000 - 171,000; Full time

Job summary

Amgen is seeking a Senior Process Development Scientist in Thousand Oaks, CA to advance formulation development for monoclonal antibodies and other biologics. You will design and execute early-stage drug product development programs, emphasizing robust fill/finish processes and scalable formulation strategies.

Collaborating cross-functionally with process development, manufacturing, and regulatory teams, you will apply DoE, automation, and data analytics to accelerate timelines while ensuring

Qualifications

• PhD/PharmD/MD as required; strong background in biologics formulation.
• Experience with high-throughput formulation screening and automated liquid handling.
• Knowledge of DoE, high-throughput analytics, and data-driven decision making.

Responsibilities

• Plan and execute formulation and fill/finish studies for early-stage programs.
• Develop liquid and lyophilized formulations for biologics; characterize CQAs.
• Build understanding of unit operations to enable scalable drug product development.
• Compare stability under clinical conditions and assess drug product integrity.
• Lead automation initiatives and collaborate with data science teams to accelerate development.

Skills

Formulation development

High-throughput screening

DoE

Automation workflows

Biologics knowledge

Education

PhD in Pharmaceutics

PharmD/MD

Tools

Hamilton systems

Tecan automation

Beckman Coulter

Opentrons

Job description

Amgen is seeking a Senior Process Development Scientist in Thousand Oaks, CA to advance formulation development for monoclonal antibodies and other biologics. You will design and execute early-stage drug product development programs, emphasizing robust fill/finish processes and scalable formulation strategies.

Collaborating cross-functionally with process development, manufacturing, and regulatory teams, you will apply DoE, automation, and data analytics to accelerate timelines while ensuring