Senior Manager, MSS Cryo Value Stream Operations

Role Summary

The Senior Manager, MSS Cryo Value Stream Operations leads a team responsible for all processes within Value Stream Cryo Operation in CAR T clinical and commercial operations in a cGMP multi-cleanroom suite. The role ensures controls, traceability, and efficient operations across retrieval, movement, storage in cryo tanks, and CRF usage, supporting multiple shifts and production areas.

Responsibilities

• Accountable to ensure completion of production tasks for Cell Therapy products to support Value Stream outputs according to cGMPs, SOPs, and Work Instructions across 4 quad shifts to support 24 hr/7 day operation.
• Promote safety and drive accountability; conduct safety Gemba walks and maintain equipment to prevent injuries or incidents.
• Maintain Production Records/Process Documentation; perform batch record reviews and ensure ALCOA+ data integrity.
• Perform Cell Therapy production steps with hands-on knowledge of Unit Operations; backfill resources as needed to meet production schedule.
• Provide Production Scheduling with information on resource availability and task progression.
• Define team priorities, set goals, monitor performance, and report metrics daily/weekly/monthly in site and functional leadership meetings.
• Ensure training requirements are met; manage training plans, proficiency, and qualification; track training due dates.
• Help build a high-performing team; participate in interviews, provide feedback, and support HR processes; foster ethics and decision-making.
• Create/manage Workday profiles for new staff; administer performance reviews and provide continuous feedback aligned with BMS values.
• Conduct regular 1:1 meetings to mentor and develop team members.
• Lead troubleshooting and deviations; document investigations and close out deviations on time; monitor deviation metrics.
• Build relationships with peers and stakeholders to drive cross-functional collaboration.
• Define strategic projects, change controls, and CAPAs; act as a change agent to improve performance and compliance.
• Control expenses within influence (OT, Supplies, T&E).
• Lead by example; model leadership aligned with BMS values of Inclusion, Accountability, Innovation, Urgency, and Passion.

Qualifications

• Basic Requirements:
  • Bachelor's degree in supply chain, engineering, life sciences, information systems, business management, or related field. Equivalent combinations may substitute.
  • 5+ years of relevant experience in a regulated pharmaceutical manufacturing environment.
  • 5+ years' experience in manufacturing areas.
  • 3+ years direct supervisory/personal management experience.
  • Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.

Knowledge & Skills

• Advanced knowledge of cGMP/GDP/Pharmaceutical regulations and applications.
• Advanced knowledge of cryopreservation, material handling, and logistics; applicable standards and qualification.
• Strong knowledge of OSHA, DEA, USP and other applicable regulations.
• Proficiency in ERP/WMS/MES and analytics tools; MS Office; communication and problem-solving skills.
• Ability to adapt to changing conditions with regulatory compliance; strong organizational and time management skills.
• Ability to travel approximately 10% of the time.

Education

• Bachelor‚Äôs degree in a relevant field (as listed in Basic Requirements).

Additional Requirements

• Working conditions include site-essential onsite requirements; ability to work in cleanroom environments and handle required PPE; potential exposure to reagents and chemicals; restricted area rules apply.