Reporting to the Chief Operating Officer (COO), the Director, Manufacturing oversees all GMP Manufacturing Operations with a focus on aseptic processing in a CDMO environment. The Director will lead sterile manufacturing processes, ensuring day-to-day operational excellence, compliance, and quality within Aseptic Formulation, Filling Operations, Inspection, Packaging, and Serialization.
ESSENTIAL DUTIES & RESPONSIBILITIES Lead and manage multidisciplinary teams in aseptic manufacturing, ensuring effective recruitment, coaching, and retention of top talent. Communicate departmental goals and performance expectations to staff, providing regular feedback and development opportunities. Oversee daily production activities for aseptic formulation, filling, inspection, and packaging operations, maintaining strict quality and safety standards. Collaborate with cross-functional teams including Engineering, Quality, Process Development, Validation, Metrology, Materials Management, and Regulatory Affairs on project execution and operational improvement. Ensure compliance with relevant global GMP regulations, championing a culture of good manufacturing practices within all manufacturing areas. Drive implementation and maintenance of standard operating procedures (SOPs) for all aspects of aseptic manufacturing operations. Partner with Project Management to optimize production schedules, facility utilization, and workforce planning to achieve maximum efficiency and throughput. Participate as manufacturing subject matter expert (SME) on internal project teams and support client engagement as required. Support the evaluation and implementation of new manufacturing technologies and continuous improvement initiatives to enhance productivity, compliance, and product quality. Maintain proper staff training and readiness in aseptic manufacturing operations. Monitor and proactively address operational risks, ensuring business continuity and meeting customer commitments. Manage operating budgets, ensuring effective use of resources for manufacturing activities. QUALIFICATIONS Bachelor’s Degree in Science, Engineering, or related discipline; Master’s preferred. 8+ years of experience in pharmaceutical manufacturing within aseptic fill/finish operations, with at least 5 years in a leadership or management capacity in a GMP/CDMO environment. Strong experience with Quality Systems and supporting successful regulatory inspections (FDA, EMA, etc.). Proven track record in lean manufacturing and continuous improvement initiatives. Excellent communication, interpersonal, and cross-functional collaboration skills. Demonstrated technical understanding of aseptic processing, commercial-scale production, and GMP compliance. Experience writing, reviewing, and implementing SOPs and regulatory documents related to aseptic manufacturing. Ability to work effectively both independently and within teams to drive operational excellence. 