Process Development Associate – Large Molecule Release Testing, Pre-Pivotal Attribute Science
Amgen
August 19, 2026
Remote friendly (Thousand Oaks, CA)
United States
Operations
Process Development Associate – Large Molecule Release Testing, Pre-Pivotal Attribute Science
What You Will Do
- Define critical quality attributes of Amgen’s therapies and advance analytical tools to support development.
- Apply cGMP principles and follow compliance requirements.
- Support incoming method transfer/qualification, method optimization, troubleshooting, and investigations in an early phase GMP environment.
- Implement and execute compendial methods (protein concentration, pH, osmolarity, color, clarity), chromatography, and capillary electrophoresis for product release, stability, characterization, method optimization, investigations, and regulatory submissions.
- Document experiments using Good Documentation Practices; generate, analyze, and critically evaluate analytical data to support release, stability, characterization, investigations, and regulatory submissions.
- Provide analytical updates, documentation, and data interpretation to analytical development teams.
- Perform routine lab maintenance (restocking, ordering, safety actions, audit readiness).
- Maintain and update monthly Work Order (WO) tracking for PM and calibration using Maximo.
- Manage reagents freezer inventory (manual counts and tracking records).
- Coordinate monthly pipette calibration, verify WO closure, and initiate HLEE investigations for out-of-tolerance results.
What We Expect Of You
Basic Qualifications:
- Bachelor’s degree
OR Associate’s degree and 2 years of operations experience
OR High school diploma/GED and 4 years of operations experience
Preferred Qualifications:
- B.S. in Cell Biology, Molecular Biology, Biomedical Engineering, Biochemistry, or related field
- Biotech/GxP experience
- Compendial techniques, chromatography, and capillary electrophoresis experience
- Experience developing, qualifying, and testing analytical methods
- Excellent documentation (GxP) and communication skills; strong attention to detail
Application Instructions:
- Apply now; no application deadline (applications accepted until sufficient candidates are received or a candidate is selected).
What You Will Do
- Define critical quality attributes of Amgen’s therapies and advance analytical tools to support development.
- Apply cGMP principles and follow compliance requirements.
- Support incoming method transfer/qualification, method optimization, troubleshooting, and investigations in an early phase GMP environment.
- Implement and execute compendial methods (protein concentration, pH, osmolarity, color, clarity), chromatography, and capillary electrophoresis for product release, stability, characterization, method optimization, investigations, and regulatory submissions.
- Document experiments using Good Documentation Practices; generate, analyze, and critically evaluate analytical data to support release, stability, characterization, investigations, and regulatory submissions.
- Provide analytical updates, documentation, and data interpretation to analytical development teams.
- Perform routine lab maintenance (restocking, ordering, safety actions, audit readiness).
- Maintain and update monthly Work Order (WO) tracking for PM and calibration using Maximo.
- Manage reagents freezer inventory (manual counts and tracking records).
- Coordinate monthly pipette calibration, verify WO closure, and initiate HLEE investigations for out-of-tolerance results.
What We Expect Of You
Basic Qualifications:
- Bachelor’s degree
OR Associate’s degree and 2 years of operations experience
OR High school diploma/GED and 4 years of operations experience
Preferred Qualifications:
- B.S. in Cell Biology, Molecular Biology, Biomedical Engineering, Biochemistry, or related field
- Biotech/GxP experience
- Compendial techniques, chromatography, and capillary electrophoresis experience
- Experience developing, qualifying, and testing analytical methods
- Excellent documentation (GxP) and communication skills; strong attention to detail
Application Instructions:
- Apply now; no application deadline (applications accepted until sufficient candidates are received or a candidate is selected).