Manager, Value Stream CAR-T Manufacturing in Summit, NJ

1 week ago

Akron, Ohio, United States Bristol-Myers Squibb Full time
Job Description

Bristol-Myers Squibb is seeking a highly skilled and experienced Manager, Value Stream CAR-T Manufacturing to join our team. As a key member of our manufacturing operations, you will be responsible for managing and overseeing the execution of Cell Therapy manufacturing processes.

Key Responsibilities:
  • Manage and provide oversight of a Work Centered Team (WCT) responsible for executing Cell Therapy manufacturing processes.
  • Ensure WCT members maintain a culture of safety, compliance, innovation, and Continuous Improvement within the Manufacturing Operations function.
  • Lead by example and drive the team to adhere to BMS values of Inclusion, Accountability, Innovation, Urgency, and Passion.
  • Accountable for ensuring WCT members execute manufacturing according to Current Good Manufacturing Practices (cGMPs) following approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).
  • Perform regular safety Gemba walks, identify hazards, and demonstrate safe behavior.
  • Operate and maintain equipment to prevent injuries or incidents.
  • Accountable for Production Records produced by WCT members, perform batch record reviews, and ensure documentation follows ALCOA+ principles.
  • Develop and maintain technical expertise of CAR-T Manufacturing requirements.
  • Provide Production Scheduling team with information on WCT production resources and track/maintain records of team members' actual availability vs planned or unplanned absence.
  • Responsible for hiring personnel that meet job description criteria and BMS values within budgetary and fiscal requirements.
  • Set WCT priorities, adjust as necessary, and track site and functional priorities, establish WCT goals, and monitor, measure, and assess performance/completion of WCT manufacturing activities and goals.
  • Report out performance metrics and goal progress daily, weekly, monthly in functional and site Tier meetings and metric control plans.
  • Ensure WCT members have appropriate training necessary for CAR-T GMP manufacturing in a multi-product commercial facility.
  • Accountable to maintain own and WCT training compliance at 100% on-time completion rate.
  • Monitor team training due dates, maintain trained status of WCT members, and ensure appropriate time is allocated to training activities.
  • Immediately disqualify personnel from GMP tasks if observed not complying with SOPs, WIs, or batch records, including safety trainings.
  • Build high-performing WCTs comprising Operators, Team Leads, and Supervisors, recruit exceptional people, conduct interviews, review candidates' suitability, and provide meaningful feedback to Talent Acquisition and HR partners.
  • Administer annual performance review process, differentiate performance between team members, give recognition when deserved, and guidance to improve poor performance or behavior not aligned with BMS values.
  • Conduct regular 1:1 meetings with each WCT member to mentor, develop, and motivate them, cascade relevant company information, and help team members with their professional development.
  • Develop cross-functional relationships with Quality Shop Floor, Warehouse, Supply Chain, and Manufacturing Science & Technology to sustain and maintain compliant manufacturing processes.
  • Work proactively to reduce deviations occurring within WCTs, drive continuous improvement to prevent repeat deviations, prepare No Impact deviation records, and ensure they are a clear and concise representation of the event.
  • Report out deviation progress, maintain deviation metrics, Pareto's out worst or repeat causes of deviations, and close out all deviations on time.
  • Provide reinforcement discussion or coaching as needed to build WCT expertise.
  • Participate in CAPAs, Change Controls, and Projects as required by the business and directed by senior management.
  • Effectively control expenses within influence (OT, Supplies, T&E).
  • Facilitate and lead weekly Tier meetings with WCT using site standard Tier meeting tools, facilitate and lead weekly Performance Review meetings with WCT using site standard Performance review meeting tools and cascading KPIs/Metrics.
  • Participate in monthly Manufacturing Performance Review meetings (facilitated by Manufacturing Senior Managers), participate in Daily Production Scheduling meeting to provide summary of WCTs training status and resource availability/constraints to execute proposed production plan in the day ahead.
  • Attend daily cross-functional manufacturing meeting providing summary of previous day activities, successes, or communicates equipment outages or processing delays.
Requirements:
  • Bachelor's degree in related field preferred, or equivalent in work experience, and ability to think and lead strategically.
  • Advanced degree preferred.
  • 5+ years of relevant manufacturing experience.
  • Minimum of 2 years leadership experiences including management of direct reports required.
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 vapor phase liquid nitrogen.
  • Will work in areas with the presence of strong magnets.
  • Must be able to work nights, weekends, and shift structure.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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