Sr Engineer, Process Development
Amgen
4 hours ago
On-site
Holly Springs, NC
Operations
Senior Engineer, Process Development
Responsibilities:
- Apply fundamental scientific principles to biopharmaceutical manufacturing processes (downstream purification) to develop process improvements, facility adaptations, and new process operations.
- Provide technical leadership and on-the-floor support for troubleshooting 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 of biologics process development or commercial-scale technology transfer and technical support experience, OR
- Bachelor’s degree and 4 years of biologics process development or commercial-scale technology transfer and technical support experience, OR
- Master’s degree and 2 years of biologics process development or commercial-scale technology transfer and technical support experience, OR
- Doctorate degree.
Preferred Qualifications:
- 4+ years of experience in Biotech/Pharma Process Development and/or Manufacturing Support for drug substance manufacturing.
- Strong, in-depth expertise in biologics purification processes (chromatography, ultrafiltration, 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, including Quality by Design (QbD) and design of experiments (DoE).
- Strong verbal and written communication skills; effective stakeholder management.
- Ability to work with moderate direction; self-starter managing multiple projects.
Benefits (explicitly stated):
- Comprehensive employee benefits package including Retirement and Savings Plan (company contributions), medical/dental/vision, life and disability insurance, and flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales representatives).
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.
Application Instructions:
- Apply at careers.amgen.com.
- No application deadline; applications will be accepted until a sufficient number is received or a candidate is selected.
- Sponsorship for this role is not guaranteed.
Responsibilities:
- Apply fundamental scientific principles to biopharmaceutical manufacturing processes (downstream purification) to develop process improvements, facility adaptations, and new process operations.
- Provide technical leadership and on-the-floor support for troubleshooting 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 of biologics process development or commercial-scale technology transfer and technical support experience, OR
- Bachelor’s degree and 4 years of biologics process development or commercial-scale technology transfer and technical support experience, OR
- Master’s degree and 2 years of biologics process development or commercial-scale technology transfer and technical support experience, OR
- Doctorate degree.
Preferred Qualifications:
- 4+ years of experience in Biotech/Pharma Process Development and/or Manufacturing Support for drug substance manufacturing.
- Strong, in-depth expertise in biologics purification processes (chromatography, ultrafiltration, 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, including Quality by Design (QbD) and design of experiments (DoE).
- Strong verbal and written communication skills; effective stakeholder management.
- Ability to work with moderate direction; self-starter managing multiple projects.
Benefits (explicitly stated):
- Comprehensive employee benefits package including Retirement and Savings Plan (company contributions), medical/dental/vision, life and disability insurance, and flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales representatives).
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.
Application Instructions:
- Apply at careers.amgen.com.
- No application deadline; applications will be accepted until a sufficient number is received or a candidate is selected.
- Sponsorship for this role is not guaranteed.