Position Summary:

Manufacturing Supervisor leads direct reports within the manufacturing operations group. Develops personnel and organizes manufacturing operations. Schedules and delegates manufacturing activities.  

1. Responsibilities:
   1. Coordinate daily production tasks and manufacturing of CAR-T cell therapy products by maintaining successful executions of batch records in compliance with current regulations and quality standards.
   2. Supervise manufacturing related activities and work cross-functionally with Quality, MS&T, Supply Chain, EH&S and Facilities to ensure safe and effective manufacturing of patient’s products.
   3. Responsible for timely execution and review of processing batch records and related manufacturing documents for release of final product.
   4. Supervise and train team members to maintain competency in manufacturing procedurces, gowning requirements, aspetic techniques and other regulatory and safety standards.
   5. Provide advanced problem solving and troubleshooting in case of any event during manufacturing activities. Acts a resource to manufacturing staff during working hours and on call for non-working hours.
   6. Write, revise, and execute technical standard operating procedures, processing batch records and other required documents.
   7. Ensure timely initiation of documentation for non-conformance, deviations, and CAPAs. Escalation to management and interaction with other stakeholders when needed.
   8. Responsible for equipment and manufacturing facility. Review and ensure accurate cleaning logs. Assist with coordination with Quality, Facilities, and EH&S to resolve facility issues and schedule maintenance and outages.
   9. Complete performance reviews, manage technical and personnel issues, assist in hiring and disciplinary actions.
   10. Find opportunities for improvement in manufacturing effcicience and compliance while assisting with investigations/deviations and change controls.
   11. Collaborate with MS&T to transfer new procedures into clinical GMP manufacturing.

 

2. Qualifications:
   1. Bachelor’s degree in relevant science or engineering discipline. Advance degree preferred.
   2. 7+ year’s experience with cGMP biologics manufacturing and/or commercial cell therapy operations, previous leadership experience preferred. 2-5 year’s experience with Master’s of Terminal degree.
   3. Advanced understanding and experience with CAR-T manufacturing to cell culture, cryopreservation, purification, filling, and aseptic processing.
   4. Excellent communication, written and verbal and strong organizational and time management skills.
   5. Knowledge of cGMP/FDA regulations, quality standards, documentation and practices.
   6. Ability to perform physical tasks requiring dexterity and mobility. Daily tasks call for routine walking, standing in cleanroom environments and occasional lifting of heavy materials.