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Manufacturing Manager, Liso-cel CAR-T, Manufacturing Operations

Manufacturing Manager, Liso-cel CAR-T, Manufacturing Operations

Bristol Myers SquibbSummit, NJ, US
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Manufacturing Manager

Working with Us Challenging. Meaningful. 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.

The purpose of the Manufacturing Manager role is to manage and provide oversight of a Work Centered Team (WCT) whose primary responsibility is the execution of Cell Therapy manufacturing processes. The Manufacturing Manager is responsible to ensure their WCT members maintain a culture of safety, compliance, innovation, and Continuous Improvement within the Manufacturing Operations function. This position reports Senior Manager, Manufacturing.

Shift Available :

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

Values :

  • Leads by example and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion

    • GMP :

  • 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).

    • Safety :

  • 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 turnaround-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.
  • Resource Management
  • 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.

    • Priorities :

  • 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 plan.

    • Training :

  • 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 maintain 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.

    • Team Building and Development :

  • 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.

    • Deviations :

  • 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.

    • CAPAs, Change Controls & Projects :

  • Participates in CAPAs, Change Controls and Projects from time to time as required by the business and directed by senior management.

    • Behaviors :

  • Maintain balanced and unbiased functional relationships, championing a culture of exceptional teamwork and communication across the organization.
  • Identifying and where possible mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
  • Develop their team through scheduled coaching sessions.
  • Instill proper problem identification behaviors.
  • Acknowledge ideas and / or issues with feedback on path forward (either yes, we will investigate that or no, not now... maybe later)
  • Coordinate across the value stream to align with appropriate goals and objectives.
  • Ability to breakdown larger goals to goals that can be influenced within their 4 walls.
  • Escalate issues at the appropriate level of urgency.
  • Participate, lead, or coach Go & See (Gemba) activities in their areas for current state understanding, process confirmation, waste reduction, increased flow, continuous improvement idea generation, coaching, or employee engagement.
  • Lead, coach or participate in Improvement & Coaching Kata at Tier Board Meetings, at the department's work area, or with individual team members to creatively experiment and deliver practical improvements to gaps to target.
  • Support their team by removing bottlenecks to problem-solving efforts and / or escalating problems or communicating resolutions through Tiered Management process.
  • Communicate expectations for the usage of Improvement / Coaching Kata, Go & See
  • Engaged and aligned in communicating and driving performance, issues, accountability and solving problems using the designed tiered management processes.
  • Recognize team and individuals for their efforts to continuously improve their processes and gaps to target conditions or to model ideal behaviors.
  • Create and continuously improve their Leader Standard Work for daily, weekly, quarterly, yearly critical tasks, run the business & improve the business activities.
  • Practice Hansei to reassess, realign, refocus teams to disconnects with desired behaviors (Accountability, Root Cause Problem Solving, Continuous Improvement, Cross Functional Collaboration, Leadership Support).
  • Take personal responsibility to work safely and ensure colleagues do the same.
  • Be the champion for continuous improvement.
  • Be purposefully present in the work area.
  • Develop a deep ownership and understanding of one's work area.
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