Process Development Associate – Large Molecule Release Testing

Amgen • Thousand Oaks, CA

2d • $74,503 - $100,799

About The Position

The Process Development Associate will support the Large Molecule Release Testing team within Pre-Pivotal Biologics Attribute Sciences. The team supports release and stability testing of toxicology and clinical batches in a phase-appropriate GMP environment and collaborates with cross-functional partners on analytical method co-development, co-qualification, and transfer. The role contributes to defining critical quality attributes of Amgen therapies and advancing analytical tools for their development.

Responsibilities include maintaining cell cultures; preparing reagents, media, and buffers; performing routine laboratory upkeep; and carrying out cell-based, binding, ELISA, and qPCR assays. The associate generates, organizes, and reports reliable data in a validated system under minimal direction, supports method hand-off and troubleshooting, and manages critical reagent freezer inventory and associated tracking records.

The position requires a bachelor’s degree, or an associate’s degree with two years of scientific experience, or a high school diploma/GED with four years of scientific experience. Preferred qualifications include a relevant scientific degree and experience with biotech industry practices, GxP, cell culture and analytical assays, analytical method development and qualification, documentation, teamwork, communication, and attention to detail.

Requirements

• Bachelor’s degree, or associate’s degree and 2 years of scientific experience, or high school diploma/GED and 4 years of scientific experience.

Nice To Haves

• B.S. or M.S. degree in Cell Biology, Molecular Biology, Biomedical Engineering, Biochemistry, or a related technical subject area.
• Demonstrated ability in the biotech industry, including experience with GxP regulations.
• Experience in cell culture, cell-based bioassay, binding assays, immunoassays, and qPCR.
• Experience developing, qualifying, and testing analytical methods.
• Excellent teamwork skills in a fast-paced GMP environment.
• Excellent documentation skills, including understanding of GxP requirements.
• Excellent oral and written communication skills and attention to detail.

Responsibilities

• Maintain cell cultures and prepare reagents, media, and buffers, along with related support.
• Perform routine laboratory maintenance, including restocking, ordering, and assisting with safety actions and audit readiness.
• Perform cell-based assays, binding assays, ELISA, and qPCR assays.
• Generate reliable data and organize and report it in a validated system under minimal direction.
• Support method hand-off and troubleshooting.
• Manage critical reagents freezer inventory through detailed manual counts and maintenance of inventory tracking records.

Benefits

• Retirement and Savings Plan with generous company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.
• Career development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level