Manufacturing Supervisor

· 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.

· Bachelor’s degree in Biological Sciences, Biomedical Engineering, or related field; advanced degree preferred.

· 6+ years of experience in a cGMP manufacturing environment, with at least 2-3 years in a supervisory or leadership role.

· In-depth knowledge of cell culture, aseptic techniques, cGMP standards, and regulatory compliance in a biotech/pharma setting.

· Proven expertise in Good Documentation Practices (GDP) and managing manufacturing documentation.

· Experience leading deviation investigations, CAPAs, and process improvement initiatives.

· Strong leadership and mentoring skills, with the ability to guide and develop a diverse manufacturing team.

· Excellent organizational and problem-solving skills, with the ability to manage multiple priorities in a fast-paced environment.

· Effective communication skills for cross-functional collaboration, training, and reporting to senior management.

· Proficiency in data analysis, technical report writing, and presenting production metrics.

· Ability to gown and work in classified cleanroom areas, ensuring compliance with ISO 7 standards.

· Primarily cleanroom-based with required time in GMP spaces overseeing manufacturing operations and team activities.

· Requires prolonged periods of standing, computer use for documentation and reporting, and full gowning in ISO 7 cleanroom.

· May involve lifting materials or equipment up to 20 pounds.

· Ability to navigate cleanroom and GMP environments for production oversight and staff training.