Technical Manager - Sterile Drug Product

Provide technical leadership for sterile drug product manufacturing operations, including aseptic processing of vials, prefilled syringes, and cartridges. Support formulation, aseptic filling, isolator/RABS systems, lyophilization, automated visual inspection, and packaging processes to ensure reliable manufacturing performance. Lead process troubleshooting, deviation investigations, root cause analysis, and implementation of CAPAs to improve product quality and operational efficiency. Drive technology transfer, scale-up, process validation, and new product introduction activities from development through commercial manufacturing. Collaborate with Engineering, Production, Quality, and external suppliers during equipment commissioning, qualification, and start-up activities. Ensure manufacturing systems operate in compliance with cGMP, FDA, and EU GMP Annex 1 requirements, maintaining inspection readiness at all times. Support contamination control strategies, environmental monitoring programs, and aseptic process simulations (media fills). Manage technical project deliverables, equipment implementation activities, and continuous improvement initiatives across the sterile manufacturing facility. Develop strong cross-functional partnerships and provide technical guidance to manufacturing and engineering teams. Requirements: Bachelor's or Master's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical discipline. 8+ years of experience within pharmaceutical or biotechnology manufacturing, with significant exposure to sterile injectable products. Demonstrated expertise in aseptic processing, sterile filling operations, isolators/RABS, lyophilization, and visual inspection technologies. Strong knowledge of cGMP regulations, FDA requirements, EU GMP Annex 1, contamination control principles, and quality risk management. Experience supporting process validation, equipment qualification (IQ/OQ/PQ), technology transfer, and commercial product launches. Proven ability to lead technical investigations, resolve complex manufacturing issues, and implement sustainable process improvements. Experience supporting regulatory inspections, customer audits, and quality system compliance activities. Previous leadership or supervisory experience within a GMP manufacturing environment is preferred. Excellent communication, stakeholder management, and project coordination skills. #J-18808-Ljbffr i-Pharm Consulting