Responsibilities
* 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.
requirements
* 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.
work environment / physical demands
* 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.
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