Manager, Value Stream Cryo Operations

Role Summary

The Manager, CAR T Value Stream Cryo Operations leads a team of Specialists, Team Leads and Associates responsible for all processes associated with Cryopreservation and Sample Management, Frozen Process Material Retrieval, Movement, and Storage within CAR T clinical and commercial operations in a cGMP multi-cleanroom suite. This role plays a critical part in ensuring production continuity, traceability, and compliance across multiple shifts in a 24/7 operation. The Manager is accountable for driving operational excellence, ensuring compliance with all regulatory requirements (FDA, DEA, DOT, ISBT, CTPAT, OSHA, VAWD, cGMPs), and fostering a culture of safety, collaboration, innovation, and continuous improvement.

Responsibilities

• Lead Cryopreservation and handling of all Cell Therapy Products across multiple production areas and shifts.
• Ensure execution of production tasks in alignment with cGMPs, SOPs, and Work Instructions while maintaining complete traceability.
• Oversee Material Retrieval, Movement, Storage, and Inventory Management within Cryotanks and Controlled Rate Freezers (CRFs).
• Maintain hands-on expertise in Unit Operations, role model good execution and behaviors, and backfill resources if needed.
• Provide production scheduling team with daily, weekly, and monthly updates on resource availability and task execution.
• Lead batch record reviews (BRR) and ensure all documentation follows ALCOA+ principles.
• Drive adherence to all training requirements, ensuring team members are proficient and qualified.
• Recruit, train, and develop a high-performing team of Managers, Leads, and Associates.
• Set and adjust team priorities to align with site and functional objectives.
• Conduct regular 1:1 meetings to mentor and support team members' professional development.
• Own the performance review process, provide continuous feedback, and recognize achievements.
• Foster a culture of accountability, ethics, and decision-making within the team.
• Champion lean principles to improve efficiency and eliminate non-value-added activities.
• Lead troubleshooting activities and own Deviation Management, ensuring timely documentation and closure.
• Monitor deviation metrics, identify repeat causes, and drive corrective actions.
• Participate in projects, change controls, and CAPAs to enhance compliance and operational performance.
• Participate and lead in process improvement projects within the department.
• Build strong cross-functional relationships to drive collaboration and alignment with stakeholders.
• Control operational expenses (OT, Supplies, T&E) and identify cost-saving opportunities.
• Take personal responsibility for safety and hold the team accountable for safe practices.
• Perform regular safety Gemba walks, identify hazards, and drive corrective actions.
• Lead and participate in Tier 1/2/3 meetings, ensuring clear communication and problem resolution.
• Promote a culture of right-first-time execution, proactive issue resolution, and continuous learning.
• Champion a culture of compliance, operational discipline, and continuous improvement.
• Lead by example, demonstrating BMS core values Inclusion, Accountability, Innovation, Urgency, and Passion.
• Drive root cause analysis and sustainable corrective actions to prevent recurrence of issues.
• Act as a change agent, promoting flexibility, creativity, and accountability in a fast-paced environment.
• Ensure knowledge sharing and cross-training across teams to build expertise.

Skills

• Advanced knowledge of cGMP/GDP/Pharmaceutical regulations and applications.
• Advanced knowledge of cryopreservation, material handling and logistics including best industry practices, application of principles, concepts, practices, standards, validation, and qualification.
• Strong knowledge and application of OSHA, DEA, USP and other applicable WH regulations.
• Proficiency in ERP systems / WMS Applications, MES and analytics tools.
• Proficiency in system and application use for business operations.
• Proficiency in MS Office applications.
• Proficiency in analytical, problem-solving, critical thinking skills and strong situational decision making.
• Proficient organizational and time management skills.
• Strong written and verbal communication skills.
• Intermediate presentation development and delivery skills.
• Ability to adapt to changing business conditions while maintaining appropriate level of controls and compliance with regulatory requirements.
• Ability to travel 10% of time.

Qualifications

• Bachelor's degree in a relevant field (Life Sciences, Engineering, Operations). An equivalent combination of education and working experience to be considered.
• 5+ years of experience in biopharmaceutical manufacturing, cell therapy, or GMP operations.
• 2 years of leadership experience managing teams.
• Strong knowledge of cryopreservation, GMP documentation, and deviation management.
• Experience driving lean manufacturing principles and continuous improvement initiatives.

Education

• Bachelor's degree in Life Sciences, Engineering, or Operations (or equivalent combination of education and experience).

Additional Requirements

• Ability to travel 10% of time.