Supervisor, Manufacturing Specialist
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About The Position
The Supervisor, Manufacturing Specialist oversees the manufacturing specialist group within the Iovance Cell Therapy Center (iCTC). This role will execute manufacturing change management at the iCTC facility, including manufacturing investigations, document authoring/editing, and deviation management. The Supervisor will also oversee special projects related to continuous improvement or new product introduction in support of the manufacturing group. This position is critical in ensuring that manufacturing operations are compliant with regulatory standards and that the team is performing at optimal levels. In this role, the Supervisor will manage the day-to-day activities of the Manufacturing Specialist Group, ensuring that all operations run smoothly and efficiently. They will be responsible for leading deviation investigations related to manufacturing operations, reviewing deviations, non-conformances, and CAPAs as required. The Supervisor will partner with Quality and other cross-functional groups to address issues effectively and compliantly, ensuring that all manufacturing processes adhere to FDA regulations and GMP systems. The Supervisor will also manage external contractors who support deviation investigations and closure for manufacturing operations. They will coordinate with team members responsible for procedure and batch record changes to support remediation, continuous improvement, or new product introduction across clinical and commercial value streams. Additionally, the Supervisor will develop and provide monthly operations metrics and indicators focused on specialist team performance and across manufacturing value streams. Identifying and managing projects for continuous improvement opportunities in manufacturing operations will be a key responsibility, in collaboration with the Operational Excellence group and other manufacturing management members. Maintaining team capability and readiness through training, performance reviews, and hiring new manufacturing specialists when necessary is also a critical aspect of this role. The Supervisor must be self-motivated and willing to accept temporary responsibilities outside of their initial job description, adapting to the fast-paced environment of a small company with changing priorities.
