Sr Engineer, Process Development

• Apply fundamental scientific principles to Biopharmaceutical manufacturing processes (Upstream and Harvest) in the development of process improvements, facility adaptations, and new process operations
• Provide technical leadership and on-the-floor support to assist in the troubleshooting of clinical and commercial drug substance manufacturing
• Support the GMP manufacturing process tech transfer, evaluations, investigations, innovation and product life cycle management
• Provide support for regulatory filing, inspection, and other CMC activities
• Develop novel mammalian next generation technologies to increase yield, process robustness, and enable new unit operations

High school diploma / GED and 10 years of biologics process development or commercial-scale technology transfer and technical support experience OR Associate degree and 8 years of biologics process development or commercial-scale technology transfer and technical support experience OR Bachelor degree and 4 years of biologics process development or commercial-scale technology transfer and technical support experience OR Master degree and 2 years of biologics process development or commercial-scale technology transfer and technical support experience OR Doctorate degree

• 4+ years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role for drug substance manufacturing
• Strong and in-depth expertise in biologics upstream and harvest processes including cell expansion, cell culture, perfusion, centrifugation, and normal flow filtration operations
• Experience in process scale-up, technology transfer, facility fit, PPQ support, MFG troubleshooting, and complex investigation
• Able to apply engineering principles and statistical analysis, including Quality by Design (QbD) and design of experiments (DoE), in-order to solve processing issues and evaluate opportunities for process improvements
• Strong verbal and written communication skills, interact effectively with diverse internal and external stakeholders
• Demonstrated ability to work in moderate direction
• Be a self-starter with the ability to take on several projects at one time
• Prior experience with automation, Delta V, electronic batch record, commission/qualification with startup site is a plus

• A 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
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible