Team Lead, Value Stream Cryo Operations
About The Position
The Team Lead, Value Stream Cryo Operations provides tactical leadership to a team of Specialists supporting the cryopreservation, movement, storage, and control of patient materials used in manufacturing, as well as the operation and maintenance of liquid nitrogen storage systems at the CAR T manufacturing facility in Summit, NJ. This role oversees cryopreservation and handling of Cell Therapy products across multiple production areas and shifts, ensuring consistent and compliant execution. Assures individual and group compliance with all applicable regulatory and corporate requirements, including FDA, DEA, DOT, ISBT, CTPAT, OSHA, VAWD, and cGMP standards. This includes oversight of training, documentation, standard operating procedures, and adherence to established policies. The position fosters a culture of safety, compliance, accountability, and continuous improvement while supporting reliable execution of manufacturing operations.
Requirements
- Associate’s degree in supply chain, engineering, life sciences, or related field
- Minimum 3 years of experience in a regulated pharmaceutical manufacturing environment
- Experience in manufacturing and supply chain operations, with at least 1 year in a leadership role
- Knowledge of cGMPs, ALCOA+ principles, and manufacturing documentation practices
- Strong problem-solving, communication, and cross-functional collaboration skills
- Equivalent combinations of education and experience may be considered
Nice To Haves
- Experience with deviations, CAPAs, change control, and batch record systems (EBR/MES/SAP) preferred
- Background in cell therapy, cryopreservation, or cold chain operations preferred
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
- Ensures all documentation is accurate, complete, and resolved promptly when discrepancies are identified
- 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
- Maintains and monitors Cryo Operations metrics to support performance and compliance
- Ensures team training compliance by managing training completion, status visibility, and overall readiness
- 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
- Contributes to performance management by providing regular feedback and reinforcing behaviors aligned with BMS values
- 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
- Builds strong cross-functional relationships and collaborates with stakeholders to drive process efficiencies
- Demonstrates problem-solving skills with minimal supervision in a fast-paced, team-based environment
- Acts as a change agent, promoting accountability, flexibility, and continuous improvement
- Leads by example, reinforcing BMS values of Inclusion, Accountability, Innovation, Urgency, and Passion
- Supports flexible operations aligned with business needs, including shift-based work, staggered hours, and overtime
Benefits
- wellbeing support
- retirement and financial protection benefits
- insurance offerings (medical, dental, vision, life and disability)
- Flexible Time Off (FTO)
- 11 paid company holidays
- 160 hours of paid vacation annually
- 3 optional holidays
- paid sick leave
- up to two paid volunteer days per year
- summer hours flexibility
- leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
- annual Global Shutdown between Christmas Day and New Year's Day
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
