Sr Engineer, Process Development
Amgen
8 days ago
On-site
Holly Springs, NC
Operations
Responsibilities:
- Apply fundamental scientific principles to biopharmaceutical manufacturing processes (upstream and harvest) to develop process improvements, facility adaptations, and new process operations.
- Provide technical leadership and on-the-floor support to troubleshoot clinical and commercial drug substance manufacturing.
- Support GMP manufacturing process tech transfer, evaluations, investigations, innovation, and product life cycle management.
- Support regulatory filing, inspection, and other CMC activities.
- Develop novel mammalian next-generation technologies to increase yield, improve process robustness, and enable new unit operations.
Basic Qualifications:
- High school diploma/GED and 10 years of biologics process development or commercial-scale technology transfer and technical support experience, OR
- Associate’s degree and 8 years, OR
- Bachelor’s degree and 4 years, OR
- Master’s degree and 2 years, OR
- Doctorate degree.
Preferred Qualifications:
- 4+ years in biotech/pharma process development and/or manufacturing support for drug substance manufacturing.
- In-depth upstream and harvest expertise (cell expansion, cell culture, perfusion, centrifugation, normal flow filtration).
- Experience with process scale-up, technology transfer, facility fit, PPQ support, manufacturing troubleshooting, and complex investigation.
- Ability to apply engineering principles and statistical analysis using QbD and DoE.
- Strong verbal/written communication; effective with diverse internal/external stakeholders.
- Demonstrated ability to work in moderate direction; self-starter managing multiple projects.
- Plus: automation, Delta V, electronic batch record, commission/qualification with startup site.
Benefits (explicitly stated):
- Comprehensive employee benefits package including retirement/savings, medical/dental/vision, life/disability, and flexible spending accounts; discretionary annual bonus/incentive; stock-based long-term incentives; time-off; flexible work models where possible.
Application instructions:
- Apply now. Amgen does not have an application deadline; applications are accepted until a sufficient number is received or a candidate is selected. Sponsorship is not guaranteed.
- Apply fundamental scientific principles to biopharmaceutical manufacturing processes (upstream and harvest) to develop process improvements, facility adaptations, and new process operations.
- Provide technical leadership and on-the-floor support to troubleshoot clinical and commercial drug substance manufacturing.
- Support GMP manufacturing process tech transfer, evaluations, investigations, innovation, and product life cycle management.
- Support regulatory filing, inspection, and other CMC activities.
- Develop novel mammalian next-generation technologies to increase yield, improve process robustness, and enable new unit operations.
Basic Qualifications:
- High school diploma/GED and 10 years of biologics process development or commercial-scale technology transfer and technical support experience, OR
- Associate’s degree and 8 years, OR
- Bachelor’s degree and 4 years, OR
- Master’s degree and 2 years, OR
- Doctorate degree.
Preferred Qualifications:
- 4+ years in biotech/pharma process development and/or manufacturing support for drug substance manufacturing.
- In-depth upstream and harvest expertise (cell expansion, cell culture, perfusion, centrifugation, normal flow filtration).
- Experience with process scale-up, technology transfer, facility fit, PPQ support, manufacturing troubleshooting, and complex investigation.
- Ability to apply engineering principles and statistical analysis using QbD and DoE.
- Strong verbal/written communication; effective with diverse internal/external stakeholders.
- Demonstrated ability to work in moderate direction; self-starter managing multiple projects.
- Plus: automation, Delta V, electronic batch record, commission/qualification with startup site.
Benefits (explicitly stated):
- Comprehensive employee benefits package including retirement/savings, medical/dental/vision, life/disability, and flexible spending accounts; discretionary annual bonus/incentive; stock-based long-term incentives; time-off; flexible work models where possible.
Application instructions:
- Apply now. Amgen does not have an application deadline; applications are accepted until a sufficient number is received or a candidate is selected. Sponsorship is not guaranteed.