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My Next Stage

Manager, Value Stream CAR-T Manufacturing

My Next Stage, Trenton, New Jersey, United States

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Overview

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 to Senior Manager, Manufacturing. Shift Available: Wednesday - Saturday (with e/o Wednesday off), Onsite Night Shift, 5 p.m. - 5:30 a.m. Responsibilities

Leads by example and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion 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). 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. Maintain hands-on expert knowledge of each Unit Operation and back-fill for absent team members as needed to meet production schedules. Further develops technical expertise of CAR T Manufacturing requirements. Provide Production Scheduling with information on resource availability and track actual vs planned absence due to holidays, sickness, or other reasons. Hire personnel that meet job description criteria and BMS values within budgetary and fiscal requirements. Priorities & Training

Sets WCT priorities, tracks site/functional priorities, and monitors performance of manufacturing activities and goals. Reports performance metrics daily, weekly, and monthly in functional and site Tier meetings and in the site metric control plan. Ensures WCTs have the appropriate level of training for CAR-T GMP manufacturing in a multi-product commercial facility and maintains 100% on-time training completion. Ensures team members are proficient and qualified to perform manufacturing tasks; monitors training due dates and maintains trained status. Disqualifies personnel from GMP tasks if SOPs, WIs, or batch records are not complied with. Team Building & Development

Builds high performing WCTs, recruits exceptional people, and coordinates with Talent Acquisition and HR partners during recruitment. Creates and maintains Workday profiles for new hires and administers annual performance reviews. Provides recognition, coaching, and regular 1:1 meetings to mentor and develop team members. Cascades information and supports professional development opportunities. Fosters a culture of learning through deviations, safety incidents, and coaching. Develops cross-functional relationships to sustain compliant manufacturing processes. Deviations, CAPAs, Change Controls & Projects

Reduces deviations and drives continuous improvement; prepares No Impact deviation records with ALCOA+ compliance; obtains Area Management approvals as needed. Reports deviation progress and closes out deviations on time; provides coaching to build WCT expertise. Participates in CAPAs, Change Controls, and Projects as required by the business. Budgets & Meetings

Controls expenses within their influence (OT, Supplies, T&E). Facilitates weekly Tier meetings and weekly Performance Review meetings with their WCT; participates in monthly Manufacturing Performance Review and Daily Production Scheduling meetings; attends daily cross-functional manufacturing meetings. Behaviors

Maintains balanced, unbiased relationships and champions teamwork and communication. Identifies and mitigates manufacturing risks to deliver safe therapies to patients. Develops the team through coaching, problem identification, and feedback. Coordinates across the value stream to align goals and break down large objectives into actionable steps. Escalates issues promptly and engages in Go & See activities, Improvement & Coaching Kata at Tier Board Meetings, and other continuous improvement practices. Communicates expectations for Improvement/Coaching Kata and visual management; drives performance, accountability, and problem-solving. Recognizes and rewards performance and ensures leadership routines are in place to maintain focus on daily operations. Develops Leader Standard Work and practices Hansei for continuous improvement and accountability. Knowledge & Skills

Extensive knowledge of EHS and cGMPs in a regulated environment; aptitude in biotechnology principles and manufacturing systems. Demonstrated ability to select and manage personnel; adaptable to fast-paced environments; knowledge of lean manufacturing principles; excellent communication skills. Basic & Preferred Requirements

Bachelor’s degree in a related field or equivalent experience; 5+ years of GMP manufacturing experience; minimum 2 years of leadership experience with direct reports. Advanced degree preferred. Working Conditions

Intermittent walking and sitting; ability to sit or stand for extended periods; comfortable with contained human blood components; PPE and cleanroom requirements; ability to lift 25 pounds. Working around laboratories, controlled areas, and restricted spaces; routine exposure to human blood components; and designated restrictions on outside materials in some areas. Compensation Overview:

Summit West - NJ - US: $103,560 - $125,495. The starting compensation range is for a full-time employee and may include incentive cash and stock opportunities. Final pay is based on experience. Benefits may include Medical, dental, vision, EAP, 401(k), disability, life insurance, paid time off, holidays, and other programs. Visit the careers site for details. Additional Information

— on-site protocol, accommodations, vaccination guidance, and equal employment opportunity statements are included as part of the role. For accessibility and other policies, see the company site information and EEO statements. BMS is an equal opportunity employer. If you live in or work from Los Angeles County, see the California residents information page for important details.

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