Process Development Associate: Biotech Analytics

BioSpace; Thousand Oaks (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Retirement plan

Health insurance

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus program

Stock-based long-term incentives

Time-off plans

Flexible work model

Job summary

Amgen is seeking a Process Development Associate for Large Molecule Release Testing in Thousand Oaks. You will define critical quality attributes and advance analytical tools to support development.

The role involves method transfer, qualification, optimization, and troubleshooting in a GMP setting, plus documentation and data interpretation to support release, stability, and regulatory submissions. Collaboration across teams is essential, with routine lab maintenance and inventory management.

Qualifications

• Bachelor's degree OR Associate's degree with 2 years operations experience or High school diploma with 4 years operations experience.
• B.S. Degree in Cell Biology, Molecular Biology, Biomedical Engineering, Biochemistry or related technical subject area.
• Experience with compendial techniques, chromatography and capillary electrophoresis.

Responsibilities

• Define critical quality attributes for Amgen therapies and support analytical tool development.
• Provide technical support for method transfer, qualification, optimization, troubleshooting and investigations in early GMP environments.
• Implement and execute compendial methods and chromatography/capillary electrophoresis for release testing and stability studies.
• Document experiments following Good Documentation Practices and analyze data to support release, stability, characterization, investigations and submissions.
• Coordinate with Product and Process Development teams, Product Quality teams to provide analytical updates and data interpretation.
• Maintain monthly work order tracking for PM and calibration activities using Maximo.
• Manage reagents inventory and assist in safety actions and audit readiness.
• Coordinate monthly pipette calibration and initiate investigations for out-of-tolerance results.

Skills

cGMP compliance

Analytical method transfer/validation

Method development & troubleshooting

Documentation & data analysis

Cross-functional collaboration

Education

Bachelor's degree

Associate's degree + 2 years operations

High school diploma + 4 years operations

Tools

Maximo

Job description

Amgen is seeking a Process Development Associate for Large Molecule Release Testing in Thousand Oaks. You will define critical quality attributes and advance analytical tools to support development.

The role involves method transfer, qualification, optimization, and troubleshooting in a GMP setting, plus documentation and data interpretation to support release, stability, and regulatory submissions. Collaboration across teams is essential, with routine lab maintenance and inventory management.