Team Lead, Value Stream Cryo Operations

Duties and 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

Qualifications

• 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
• Experience with deviations, CAPAs, change control, and batch record systems (EBR/MES/SAP) preferred
• Background in cell therapy, cryopreservation, or cold chain operations preferred
• Strong problem-solving, communication, and cross-functional collaboration skills
• Equivalent combinations of education and experience may be considered