Engineer - Drug Substance Technology & Engineering

Amgen • Thousand Oaks, CA

2d • $88,281 - $119,439 • Onsite

About The Position

Amgen is seeking an Engineer to join the Drug Substance Technology & Engineering (DSTE) team at its Thousand Oaks, California site. This onsite role provides downstream purification process engineering support for a portfolio of clinical and commercial biologics drug substance products across the network. The Engineer supports technology transfer, process validation, and manufacturing of human therapeutic biological drug substances, from clinical development through commercial production. The role applies engineering principles to implement manufacturing processes in a cGMP environment and works with engineers and scientists to translate developmental processes into commercial manufacturing.

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.
• 3 or more years of experience in process engineering related to biochemical engineering and/or protein biochemistry, scale-up principles, and cGMP biologics manufacturing.
• Downstream process knowledge and hands-on purification pilot, clinical, or commercial experience in biological drug substance manufacturing.
• Experience working in or supporting a commercial cGMP manufacturing facility.
• Understanding of purification processes and related equipment, including scale-up from bench to commercial scale, chromatography, viral inactivation, viral filtration, ultrafiltration, and diafiltration, and the impact of process deviations on yield and quality attributes.
• Knowledge of aseptic processing and techniques, harvest and clarification processes used in mammalian cell culture, and/or purification processes and associated equipment such as chromatography, ultrafiltration, normal-flow filtration, virus inactivation, and virus filtration operations.
• Process Development experience supporting large-scale cGMP manufacturing.
• Strong scientific, engineering, and laboratory analysis and troubleshooting capabilities, with sophisticated problem-solving skills.
• Ability to develop and follow detailed protocols.
• Self-motivation, ability to multitask, and ability to work in teams.
• Excellent written and verbal communication skills, including technical writing and presentations.

Nice To Haves

• Master’s degree in Chemical Engineering, Biochemical Engineering, or a related subject area.

Responsibilities

• Transfer purification drug substance processes and process improvements from laboratories to manufacturing facilities and between manufacturing sites.
• Provide solutions to technical problems of moderate scope and complexity.
• Evaluate, select, and apply standard engineering techniques and procedures under general supervision, seeking assistance for unusual problems.
• Support process validation for late-stage commercial processes.
• Provide on-the-floor technical support for process scale-up, technology transfer, and clinical and commercial manufacturing operations.
• Perform routine and nonroutine process monitoring and troubleshooting.
• Support nonstandard shift schedules and extended hours as business needs require.
• Trend process data and perform statistical analyses.
• Provide technical input for process-related deviations (NCs), CAPAs, and change controls.
• Identify and support process-related operational excellence and continuous improvement opportunities, including improving efficiency across business process workstreams.
• Represent Process Development and collaborate with Manufacturing, Quality, Regulatory, Research, Maintenance, Utilities, Facilities, and Validation teams to develop requirements and recommendations for process or system modifications.
• Communicate and collaborate with technical and management staff across Manufacturing, Process Development, and Quality.
• Complete assignments with clear objectives that require investigating a limited number of variables.
• Serve as a technical expert for equipment and systems troubleshooting, participating in daily operations as needed to meet schedules or resolve complex problems.
• Apply engineering principles and statistical methods, including design of experiments, to resolve processing issues and evaluate process improvement opportunities.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and 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: Mid Level