Process Development Associate – Large Molecule Release Testing

Amgen•Thousand Oaks, CA

About The Position

The Process Development Associate will work on Amgen’s Large Molecule Release Testing team within the Pre-Pivotal Biologics Attribute Sciences function. 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 method transfer. The role contributes to defining critical quality attributes of Amgen therapies and advancing analytical tools to support their development. The associate performs laboratory assays and related cell culture and preparation work, maintains laboratory operations and critical reagent inventory, generates and reports reliable data in a validated system, and supports method hand-off and troubleshooting. The position requires a relevant educational or scientific-experience background. A bachelor’s degree is required, 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 relevant life-science education, biotechnology and GxP experience, assay and analytical-method experience, teamwork, documentation, communication, and attention to detail.

Requirements

Bachelor’s degree, or an associate’s degree and 2 years of scientific experience, or a 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 biotechnology industry, including experience with GxP regulations.
Experience in cell culture, cell-based bioassays, 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, assisting with safety actions, and supporting audit readiness.
Perform cell-based assays, binding assays, ELISA, and qPCR assays.
Generate robust and reliable data, and organize and report data 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

Health and welfare plans for staff and eligible dependents.
Financial plans with opportunities to save toward retirement or other goals.
Work/life balance and career development opportunities.
Comprehensive employee benefits package including a 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.