Team Lead, Value Stream Cryo Operations
Core
Provides tactical leadership to a team of Specialists supporting cryopreservation, movement, storage, and control of patient materials used in manufacturing, as well as the operation and maintenance of liquid nitrogen storage systems at a CAR T manufacturing facility.
Role type
Team Lead, Cryo Operations (Manufacturing)
Builds
Cell Therapy products (CAR T)
Domain
Biopharmaceuticals / Cell Therapy / Cryopreservation
Required skills
cGMP compliance, ALCOA+ documentation principles, batch record review, cryopreservation operations, liquid nitrogen storage management, patient material handling, team leadership, deviation investigation, CAPA management, change control, shift-based operations, inventory control, training management
Preferred skills
Cell therapy background, cold chain operations, batch record systems (EBR/MES/SAP), deviation/CAPA/change control experience
Technologies
EBR, MES, SAP
Responsibilities
Accountable for execution of Cell Therapy production activities in compliance with cGMPs, SOPs, and work instructions; Drives a strong safety culture by reinforcing safe practices, promoting accountability, and participating in routine Gemba walks; Oversees production documentation, including batch record review (BRR) and exception-based EBR review, ensuring alignment with ALCOA+ principles; Maintains hands-on expertise in cryopreservation operations, including daily processing, LN2 storage management, and inventory control; Oversees patient material handling, including cryopreservation, storage, distribution, transfer, and disposal, ensuring proper tracking and chain of custody; Provides leadership with timely updates on production status, resource availability, and task progression; Aligns team execution with site priorities and production schedules, including BioG commitments, to ensure on-time delivery; Tracks and reports performance metrics through Tier meetings and other site reporting mechanisms; Ensures team training compliance by managing training completion, status visibility, and overall readiness; Supports deviation investigations by gathering relevant information, documenting events clearly, and assisting with timely closure; Participates in projects, change controls, and CAPAs to improve operational performance and maintain compliance; Partners with management to ensure adequate staffing and qualified personnel to support operations; Supports development of a high-performing team through coaching, feedback, and engagement with leadership and HR.
Seniority
Mid-level Lead (3+ years experience, 1+ year leadership)