Manager, Value Stream CAR-T Manufacturing

Manager, Value Stream Cryo Operations

Working with us is challenging, meaningful, and life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.

Our Manager, Value Stream Cryo Operations is responsible for the cryopreservation, movement, storage, control of manufacturing patient materials, and support of liquid nitrogen storage tanks and equipment at the CAR T manufacturing facility in Summit, NJ. This includes but is not limited to, cryopreservation, storage, inventory control, chain of custody, and material tracking.

Shift Available:

• Wednesday - Saturday (with e/o Wednesday off), Onsite Night Shift, 5 p.m. - 5:30 a.m.

Responsibilities:

• Leads by example and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency, and Passion
• Is accountable to ensure their WCT members execute the manufacturing of Cell Therapy products according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Takes personal responsibility to work safely and to ensure their WCT members do the same.
• Performs regular safety Gemba walks, knows the hazards associated with their work and demonstrates safe behavior.
• Operates and maintains equipment to prevent injuries or incidents.
• Is accountable for the Production Records produced by their WCT members.
• Performs batch record reviews (BRR) or Electronic Batch Record review by exception.
• Ensures that all documentation produced by their WCT members follows the ALCOA+ principles.
• Ensures the documentation produced by their WCT members is right first time and all records and logbooks are complete and accurate.
• Resolve documentation errors and corrections as needed to enforce manufacturing turn-around-times.
• Is required to perform Cell Therapy manufacturing to maintain hands on expert knowledge of each Unit Operation, demonstrate what good execution looks like to new WCT members and when necessary, back fills for absent team members or makes up the execution resource requirements to meet the production schedule.
• Further develops technical expertise of CAR T Manufacturing requirements.
• Is responsible to provide the Production Scheduling team with information (daily, weekly monthly) on the availability of their WCT production resources and tracks/maintains records of all team members actual availability vs planned or unplanned absence due to holidays, sickness or other reasons.
• Is responsible to hire personnel that meet job description criteria and BMS values that meet budgetary and fiscal requirement.
• Sets their WCTs priorities and adjusts as necessary to track the site and or functional priorities, establishes the WCT goals and is responsible to monitor, measure and assess the performance/completion of the WCT manufacturing activities and goals.
• Reports out performance metrics and goal progress daily, weekly, monthly in functional and site Tier meetings and the site metric control plans.
• Ensures that their WCTs have the appropriate level of training necessary for CAR-T GMP manufacturing in a multi-product commercial facility.
• Accountable to maintain their own and WCTs training compliance at the required 100% on-time completion rate.
• Ensures that their WCT members are proficient and qualified to perform the manufacturing tasks before doing so.
• Monitors team training due dates and maintains the trained status of their WCT members by ensuring appropriate time is allocated to training activities.
• Immediately disqualifies personnel from GMP tasks if observed to not comply with SOPs, Wis, or batch records, including safety trainings.
• Is responsible to build high performing WCTs comprising of, Operators, Team Leads and Supervisors.
• Recruits exceptional people, conducts interviews, reviews candidates' suitability and provides meaningful feedback to Talent Acquisition and HR partners during the recruitment process.
• Is responsible to create and maintain Workday profiles for all new hired staff.
• Is responsible to administer the annual performance review process, differentiating performance between team members.
• Gives recognition when deserved and guidance to improve poor performance or behavior not aligned with the BMS values.
• Conducts regular 1:1 meeting with each WCT member to mentor, develop and motivate them.
• Cascades relevant company information and takes time to help team members with their professional development including seeking out potential career development opportunities.
• Creates a culture of learning via discussion of deviations, safety incidents, and provides meaningful, timely, and accurate coaching during processing.
• Develops cross-functional relationships with Quality Shop Floor, Warehouse, Supply Chain and Manufacturing Science & Technology to sustain and maintain compliant manufacturing processes.
• Works proactively to reduce the number of deviations occurring within the WCTs and is accountable to drive continuous improvement to prevent repeat deviations.
• Prepares No Impact deviation records and ensures they are a clear and concise representation of the event and that all entries comply with ALCOA+ documentation principles.
• Provides Area Management Approval for deviations within their WCT as needed.
• Reports out deviation progress, maintains their deviation metrics, Pareto's out worst or repeat causes of deviations and closes out all deviations on time.
• Provides reinforcement discussion or coaching as needed to build WCT expertise.
• Participates in CAPAs, Change Controls and Projects from time to time as required by the business and directed by senior management.
• Effectively controls expenses within their influence (OT, Supplies, T&E).
• Is responsible to facilitate and lead weekly Tier meetings with their WCT using the site standard Tier meeting tools.
• Is responsible to facilitate and lead weekly Performance Review meetings with their WCT using the site standard Performance review meeting tools and cascading KPIs/Metrics.
• Is responsible to participate in the monthly Manufacturing Performance Review meetings (facilitated by the Manufacturing Senior Managers).
• Is responsible to participate in the Daily Production Scheduling meeting to provide a summary of their WCTs training status and resource availability/constraints to be able to execute the proposed production plan in the day ahead.
• Attends the daily cross-functional manufacturing meeting providing summary of previous day activities, successes, or communicates equipment outages or processing delays.

Knowledge & Skills:

• Extensive knowledge of EHS and cGMPs and the knowhow to work and manage within a regulated environment.
• Demonstrates aptitude for biotechnology principles and manufacturing systems.
• Demonstrated proficiency in selection of team and effectively managing personnel issues.
• Adaptable to a fast paced, complex and ever-changing business environment.
• Knowledge of lean manufacturing principles required.
• Excellent communication skills (EN).
• The ability to think and lead strategically.

Minimum Requirements:

• Bachelor's degree in related field. Advanced degree preferred. An equivalent combination of education and work experience to be considered.
• 5+ years of relevant GMP manufacturing experience.
• 2 years minimum of cell therapy manufacturing experience.
• 2 years minimum of leadership experiences.
• Must be able to interact within a clean room environment.

Working Conditions:

• Must be able to work in a cleanroom environment that requires gowning.
• Must be able to stand for extended periods of time (6+ hours).
• Work in areas where handling human blood products (Biosafety Level 2) will be required.
• Will work in areas with exposure to