Neo Consulting Group Hiring For Manufacturing Operations Supervisor at Durham, NC, United States Full Time

Job Description

About Client:
Our client is a biopharmaceutical company with operations in China and the U.S. focused on innovative CAR-T cell therapies – the company has built an integrated cell therapy platform with in-house capabilities that span target discovery, antibody development, clinical trials, and commercial-scale manufacturing.
We are searching for a highly motivated Manufacturing Operations Supervisor open to working a 12-hour shift schedule and on call for non-working hours.
Responsibilities:

• 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.
• Lead or 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 products.
• Responsible for timely execution and review of processing batch records and related manufacturing documents for the release of the final product.
• Supervise and train team members to maintain competency in manufacturing procedures, gowning requirements, aseptic techniques, and other regulatory and safety standards.
• Provide advanced problem solving and troubleshooting in case of any event during manufacturing activities. Acts as a resource to manufacturing staff during working hours and is on call for non-working hours.
• Write, revise, and execute technical standard operating procedures, processing batch records, and other required documents.
• Ensure timely initiation of documentation for non-conformance, deviations, and CAPAs. Escalation to management and interaction with other stakeholders when needed.
• 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.
• Complete performance reviews, manage technical and personnel issues, and assist in hiring and disciplinary actions.
• Find opportunities for improvement in manufacturing efficiency and compliance while assisting with investigations/deviations and change controls.
• Collaborate with MS&T to transfer new procedures into clinical GMP manufacturing.

Requirements:

• Bachelor’s degree in a relevant science or engineering discipline. Advance degree preferred.
• 7+ years experience with cGMP biologics manufacturing and/or cell therapy operations, previous leadership experience preferred. 2-5 years experience with a Master’s degree.
• Advanced understanding and experience with CAR-T manufacturing to cell culture, cryopreservation, purification, filling, and aseptic processing.
• Excellent communication, written and verbal, and strong organizational and time management skills.
• Knowledge of cGMP/FDA regulations, quality standards, documentation, and practices.
• 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.