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

Bristol Myers Squibb • Summit, NJ

11d • Onsite

About The Position

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. Read more: careers.bms.com/working-with-us. 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. The purpose of the Manufacturing Manger 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 to Senior Manager, Manufacturing. Shift Available: Sunday - Wednesday (with every other Wednesday off), Onsite Night Shift, 5 p.m. - 5:30 a.m.

Requirements

• 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)
• Bachelor’s degree in related field is preferred. An equivalent combination of education and work experience will be considered.
• 5+ years of GMP manufacturing experience.
• Minimum of 2 years leadership experience including management of direct reports required.

Nice To Haves

• Advanced degree preferred.

Responsibilities

• 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.
• Documentation 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.
• Process Expertise 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/maintain 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 requirements.
• 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% ontime 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, Work Instructions, 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 for creating and maintaining Workday profiles for all new hired staff. Is responsible for administering 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.
• Budgets: Effectively controls expenses within their influence (OT, Supplies, T&E).
• Meetings: Is responsible to facilitate and lead weekly Tier meetings with their WCT using the site standard Tier meeting tools. Is responsible for facilitating and leading weekly Performance Review meetings with their WCT using the site standard Performance review meeting tools and cascading KPIs/Metrics. Is responsible for participating in the monthly Manufacturing Performance Review meetings (facilitated by the Manufacturing Senior Managers). Is responsible for participating 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 communicating equipment outages or processing delays.
• 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 break down 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 disconnect 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.

Benefits

• 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.
• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level