Senior Manager, Process Engineering Drug Substance and Drug Product

Role: Senior Manager of Process Engineering leading teams supporting GMP biopharmaceutical manufacturing of drug substance and drug product, with a focus on technology transfer, equipment selection, troubleshooting, deviation investigation, and regulatory compliance. Responsibilities: oversee technical teams to ensure right-first-time quality; support process development, qualification, and transfer activities; partner with Operations, Quality, and Automation functions; develop technical documentation; lead fault analysis and issue resolution; support regulatory inspections; work hands-on in manufacturing environments. Requirements: minimum 7 years in GMP biopharmaceutical operations support, with at least 5 years in project management within biologics; proven leadership and team development skills; experience in design, troubleshooting, and qualification of manufacturing systems and equipment; strong problem-solving and decision-making abilities. Preferred: familiarity with OE/LEAN methodologies. High-Value: biologics, drug substance and drug product manufacturing, GMP, technology transfer, troubleshooting, deviation investigations, regulatory inspections, industry experience in manufacturing environments. WorkSetup: on-site in Hopewell, NJ, with up to 5% travel.