Team Lead, Value Stream Cryo Operations

Posted 2 days ago

scorpion therapeuticsSummit (NJ)

First-Line Supervisors of Production and Operating Workers Biological Product (except Diagnostic) Manufacturing

SENIORITY

Manager

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About the role

Role: Team Lead for cryopreservation operations at a CAR T manufacturing facility, responsible for overseeing the handling, storage, and movement of patient materials and liquid nitrogen systems to ensure compliance and operational efficiency. Responsibilities include managing cryopreservation activities across shifts, maintaining regulatory adherence (FDA, cGMP, OSHA), overseeing documentation and batch record review, and leading safety and quality initiatives. The role involves hands‑on expertise in cryopreservation, inventory control, and patient material handling, alongside team leadership, training, and performance management. Collaborates with cross‑functional stakeholders to optimize processes and supports continuous improvement projects.

Qualifications: Associate’s degree in supply chain, engineering, life sciences, or related field; minimum 3 years' experience in regulated pharmaceutical manufacturing; at least 1 year in a leadership role. Knowledge of cGMP, ALCOA+ principles, manufacturing documentation, and experience with deviations, CAPAs, and change controls are required. Preferred background includes cell therapy, cryopreservation, or cold chain operations. High‑Value: Cell therapy (CAR T), cryopreservation, process compliance, GMP, patient material handling, shift‑based operations, team leadership, regulation adherence. Work setup involves shift work with flexibility for overtime and staggered hours.

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