Manufacturing Manager

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 team, you will be responsible for managing and providing oversight of a Work Centered Team (WCT) whose primary responsibility is the execution of Cell Therapy manufacturing processes.

• Manage and provide oversight of a WCT whose primary responsibility is the execution of 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 the BMS values of Inclusion, Accountability, Innovation, Urgency, and Passion.
• Accountable to ensure 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).
• Perform regular safety Gemba walks, know the hazards associated with their work, and demonstrate safe behavior.
• Operate and maintain equipment to prevent injuries or incidents.
• Accountable for the Production Records produced by WCT members.
• Perform batch record reviews (BRR) or Electronic Batch Record review by exception.
• Ensure that all documentation produced by WCT members follows the ALCOA+ principles.
• Ensure the documentation produced by 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.
• 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, backfill for absent team members or make up the execution resource requirements to meet the production schedule.
• Further develop technical expertise of CAR-T Manufacturing requirements.
• Provide the Production Scheduling team with information (daily, weekly, monthly) on the availability of WCT production resources and track/maintain records of all team members' actual availability vs planned or unplanned absence due to holidays, sickness, or other reasons.
• Responsible to hire personnel that meet job description criteria and BMS values that meet budgetary and fiscal requirements.
• Sets WCT 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 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 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 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.
• 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.
• Responsible to create and maintain Workday profiles for all new hired staff.
• 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 meetings 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 a summary of previous day activities, successes, or communicates equipment outages or processing delays.

• Extensive knowledge of EHS and cGMPs and the know-how 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).
• 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 look into 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.
• Establish performance measures and targets to drive improvements.
• Participate in reviews of performance, generate improvement ideas, and take action.
• Use visual management so no problem is hidden.
• Build a culture of finding root causes and take action to prevent them from recurring.
• Know the value stream for the product/service you are providing to your customers.
• Use actual results to identify waste, reduce variation, and improve productivity.

• Bachelor's degree in a related field is preferred, or equivalent in work experience, and the ability to think and lead strategically. Advanced degree preferred.
• 5+ years of relevant manufacturing experience.
• Minimum of 2 years leadership experiences including the management of direct reports required.

• 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.