Engineer I Upstream Drug Substance Technologies and Engineering

Amgen•Thousand Oaks, CA

1d•$88,281 - $119,439

About The Position

Amgen is seeking an Engineer to join its Drug Substance Technology Engineering team supporting the Thousand Oaks (ATO) Drug Substance Manufacturing facilities. The role supports technology transfer and process validation for human therapeutic products (biological drug substance) across clinical and commercial manufacturing. The position involves transferring and improving cell culture drug substance processes from the laboratory into manufacturing facilities and between sites, supporting late-stage commercial process validation, and providing technical support for scale-up, technology transfer, and manufacturing operations. It also includes routine process monitoring and troubleshooting, data trending and statistical analysis, contributions to deviations, CAPAs and change controls, and identifying operational excellence opportunities. The engineer represents process development and collaborates with Manufacturing, Quality, Regulatory, and other functions.

Requirements

Master’s degree; or bachelor’s degree and 2 years of Process Development experience; or associate’s degree and 6 years of Process Development experience; or high school diploma/GED and 8 years of Process Development experience.

Nice To Haves

Master’s degree in Chemical/Biochemical Engineering or a related subject area.
3 or more years of Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles, and cGMP biologics manufacturing.
Upstream process knowledge and hands-on cell culture and/or purification pilot, clinical, or commercial experience in biological drug substance manufacture.
Experience working in or supporting a commercial cGMP manufacturing facility.
Firm understanding of cell culture processes and related equipment, including bench-to-commercial scale-up, mass oxygen transfer capabilities, metabolism profiling, raw material attribute effects, and the impact of process deviations on growth and quality attributes.
Knowledge of aseptic processing and techniques, and mammalian cell culture harvest and clarification processes; and/or understanding of purification processes and associated equipment, including chromatography, ultrafiltration, normal flow filtration, virus inactivation, and virus filtration.
Process Development experience supporting large-scale cGMP manufacturing.
Strong scientific, engineering, and laboratory analysis capabilities, troubleshooting skills, and ability to apply sophisticated problem-resolution methods.
Ability to develop and follow detailed protocols.
Self-motivation, ability to multitask, and ability to work in teams.
Excellent written and verbal communication, including technical writing and presentations.

Responsibilities

Transfer cell culture drug substance processes and perform process improvements from the laboratory into manufacturing facilities and between manufacturing sites.
Provide process validation support for late-stage commercial processes.
Provide on-the-floor technical support for scale-up and transfer of process technology, and for clinical or commercial manufacturing operations.
Perform routine process monitoring and troubleshooting.
Perform data trending and statistical process analysis.
Provide technical contributions for process-related deviations (NCs), CAPAs, and change controls.
Identify and support process-related operational excellence opportunities.
Represent process development and collaborate with functions such as Manufacturing, Quality, and Regulatory.

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.