Sr Engineer, Process Development

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, DeltaV, electronic batch record, commission/qualification with startup site. Benefits 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. #J-18808-Ljbffr Scorpion Therapeutics