· Supervise the manufacturing team, including Technicians, Associates (I-II, III, III-Lead), to ensure seamless execution of production tasks such as cell culture, media preparation, formulation, centrifugation, and freezing.
· Ensure all manufacturing activities comply with cGMP standards, overseeing proper documentation, inventory management, and cleanroom operations.
· Review and approve cGMP documentation, including batch records, logs, forms, and protocols, ensuring accuracy and adherence to Good Documentation Practices (GDP).
· Monitor production processes, analyze data, and report on performance metrics to identify areas for improvement and ensure quality goals are met.
· Coordinate with the Associate Director of Manufacturing to develop production schedules, allocate resources, and address operational challenges.
· Lead training and mentoring of manufacturing staff, ensuring team competency in aseptic techniques, cGMP standards, and manufacturing procedures.
· Oversee the initiation, investigation, and closure of deviations, CAPAs, and process improvements, ensuring timely resolution and documentation.
· Author, review, and update standard operating procedures (SOPs) and other manufacturing documentation using the document change system.
· Manage inventory, material transfers, and cleanroom setup/shutdown activities to support continuous manufacturing operations.
· Facilitate cross-functional collaboration with Quality Control, Materials Management, and other departments to ensure production alignment with company objectives.
· Lead special manufacturing and development projects as assigned by the Associate Director of Manufacturing.
· Perform other duties as assigned to support manufacturing operations and company goals.