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.