Manager, Cell Therapy Manufacturing in Summit, NJ

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. 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 Senior Manager, Manufacturing. **Shifts Available:** - Q4: Wednesday - Saturday (with every other Wednesday off), Onsite Night Shift, 5 p.m. - 5:30 a.m. **Responsibilities will include, but are not limited to the following:** 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 turn-around-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/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 plans. 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 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. 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. 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 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. 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. - 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. **Knowledge, Skills & Abilities:** - 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) **Minimum Requirements:** - Bachelor’s degree in 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. **Working Conditions:** - Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary. - Must be comfortable working with contained human blood components. - Physical dexterity sufficient to use computers and documentation. - Sufficient vision and hearing capability to work in job environment. - Ability to lift 25 pounds. - Must have the ability to work around laboratories and controlled, enclosed, restricted areas. - Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet. - Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas. - Flexibility to don clean room garments and personal protective equipment (PPE). - Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. - Reagents, chemicals, and exposure to sanitization agents are expected. - Routine exposure to human blood components. Exposure to strong magnets is likely. - Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum. - This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. - The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. - This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. - There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. - Employees holding this position will be required to perform any other job-related duties as requested by management. **BMSCART** **#LI-ONSITE** We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway. ******Compensation Overview:****** Summit West - NJ - US: $103,560 - $125,495 The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance. **Benefits:** Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability). U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year. Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays. Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day. U.S.-based job seekers can explore full benefit offerings at **How We Work** Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at [](https://careers.bms.com/life-at-bms/ways-of-working/) **Supporting People with Disabilities** BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [adastaffingsupport@bms.com](mailto:adastaffingsupport@bms.com). Visit [](https://careers.bms.com/eeo-accessibility) to access our complete Equal Employment Opportunity statement. **Candidate Rights** BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: **Data Protection** We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at [](http://careers.bms.com/fraud-protection). Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [TAEnablement@bms.com](mailto:TAEnablement@bms.com)with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account. R1605595 : Manager, Cell Therapy Manufacturing in Summit, NJ