Pharmaceutical Manufacturing Operations Director

Position Summary Ascendia Pharmaceutical Solutions is seeking an experienced, results-oriented Pharmaceutical Manufacturing Operations Director to lead and manage daily pharmaceutical manufacturing activities at our North Brunswick, New Jersey facility. This position is responsible for the safe, compliant, efficient, and timely execution of manufacturing operations supporting clinical and commercial-stage pharmaceutical development programs. The role encompasses sterile and non-sterile manufacturing activities, including formulation preparation, compounding, aseptic processing, sterile filtration, filling, lyophilization, visual inspection, and related manufacturing support activities, as applicable. The successful candidate will combine strong technical manufacturing knowledge with hands-on operational leadership, a thorough understanding of current Good Manufacturing Practices (cGMP), and a demonstrated ability to manage manufacturing personnel, equipment, production schedules, and cross-functional priorities. Operating within a dynamic Contract Development and Manufacturing Organization (CDMO), the Manufacturing Operations Director must balance competing client requirements, aggressive project timelines, regulatory expectations, and resource constraints while maintaining an uncompromising commitment to product quality, patient safety, and operational excellence. This is a highly visible leadership position requiring accountability, initiative, sound judgment, and the ability to translate manufacturing plans into reliable execution. Key Responsibilities 1. Manufacturing Operations Leadership Direct and coordinate daily pharmaceutical manufacturing activities across assigned production areas, including sterile and non-sterile operations. Oversee manufacturing activities involving formulation, compounding, filtration, aseptic filling, lyophilization, visual inspection, and other applicable drug product operations. Ensure manufacturing activities are performed in accordance with approved Master Batch Records (MBRs), Standard Operating Procedures (SOPs), established manufacturing instructions, and cGMP requirements. Develop, implement, and execute daily and weekly manufacturing schedules in coordination with Project Management, Supply Chain, Quality, and Technical Operations. Manage manufacturing personnel, equipment utilization, material availability, and production readiness to meet project milestones and client commitments. Identify and resolve operational constraints, scheduling conflicts, equipment issues, and manufacturing inefficiencies. Provide direct shop-floor leadership during critical manufacturing activities, troubleshooting, and production campaigns. Ensure effective shift handovers, production communication, and operational continuity. Establish clear accountability for manufacturing deliverables, timelines, quality, and performance. 2. Aseptic Manufacturing and Contamination Control Provide operational leadership and oversight of aseptic manufacturing activities within classified cleanroom environments. Ensure appropriate aseptic techniques, cleanroom behaviors, personnel gowning practices, and contamination prevention measures are consistently followed. Support aseptic process simulations (APS/media fills), personnel qualifications, environmental monitoring activities, and aseptic process readiness. Ensure adherence to established cleaning, sanitization, disinfection, sterilization, and contamination control procedures. Collaborate with Quality Assurance, Microbiology, Validation, and Engineering to maintain appropriate cleanroom and manufacturing controls. Support implementation and continuous improvement of the site's Contamination Control Strategy (CCS). Ensure appropriate controls for personnel, equipment, materials, and waste movement within classified manufacturing environments. Identify potential contamination risks and implement corrective actions to protect product quality and sterility assurance. 3. cG…

View the full posting and apply