Biologics Process Development Scientist

Biopharma Careers; Thousand Oaks (CA); Hybrid; USD 90,000 - 122,000; Full time

Job summary

Amgen is seeking a Process Development Associate Scientist to advance early-stage biologics formulation and fill/finish processes. You will work in Pre-Pivotal Drug Product Technologies, focusing on monoclonal antibodies and other biologics, and collaborate across teams to drive robust, scalable drug product solutions.

You will design experiments, develop liquid and lyophilized formulations, and apply DoE and automation to accelerate discovery while ensuring critical quality attributes meet

Qualifications

• Master’s degree or higher in a relevant field.
• Experience with biologics formulation development and fill/finish operations.
• Experience with high-throughput formulation development and automation tools.

Responsibilities

• Join Pre-Pivotal Drug Product Technologies group for early-stage biologics development.
• Plan and execute formulation and stability studies for early-stage programs.
• Develop and characterize liquid and lyophilized biologics formulations.
• Investigate CQAs and inform design decisions.
• Design automated screening workflows and DoE studies.
• Implement laboratory automation and data capture improvements.
• Apply ML/AI to modeling and decision-making.
• Prepare regulatory documents and transfer protocols.

Skills

Formulation development

High-throughput

Laboratory automation

Data analysis

DoE

Robotic workflows

Written communication

Education

Master’s degree

Bachelor’s degree + 2 years experience

Associate’s degree + 4 years experience

High school diploma + 6 years experience

Tools

Hamilton

Tecan

Beckman Coulter

Opentrons

HPLC/UPLC

Job description

Amgen is seeking a Process Development Associate Scientist to advance early-stage biologics formulation and fill/finish processes. You will work in Pre-Pivotal Drug Product Technologies, focusing on monoclonal antibodies and other biologics, and collaborate across teams to drive robust, scalable drug product solutions.

You will design experiments, develop liquid and lyophilized formulations, and apply DoE and automation to accelerate discovery while ensuring critical quality attributes meet