Bristol Myers Squibb
Associate Director, CAR-T Manufacturing Operations
Bristol Myers Squibb, Summit, New Jersey, United States, 07901
Associate Director, Value Stream CAR T Manufacturing
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. 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 Associate Director, Value Stream CAR T Manufacturing role is to manage and provide oversight of a team of Manufacturing Sr. Managers, Managers, and their Work Centered Teams (WCT) operating in shifts over a 24/7 schedule whose primary responsibility is the execution of Cell Therapy manufacturing processes, maintaining a culture of safety, compliance, innovation, and Continuous Improvement within the Manufacturing Operations function. Shift Available: Tuesday - Saturday, Onsite Afternoon Shift, 3 p.m. - 11:30 p.m. Responsibilities
Values Leads by example and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion. Leads with empathy while maintaining team accountability. Able to achieve results while creating an engaging, accountable, and learning culture. GMP Is accountable to ensure their Manufacturing Sr. Managers, Managers and 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). Responsible to own, review, author, or approve SOP, WI, master batch records. Responsible for setting strategic direction for the WCT while maintaining or exceeding compliance, budgetary, safety, and technical requirements. Has direct experience and success with Health Authorities and is capable to defend CAR-T manufacturing processes. Provides compliant solutions to technical issues or for continuous improvement programs. Develop and deliver against project plans that support technical transfers, APS, new equipment installations. Support and approve technical documents for the IQ/OQ/PQ, UAT Testing, and other equipment or process enhancements. Safety Takes personal responsibility to work safely and to ensure their managers and 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. Conducts monthly safety inspections and proactively partners with the EHS team for safety updates, initiatives, or trainings. Provides support for any safety inspections (internal or external) as requested. Acts as a Safety Change Agent supporting safety initiatives and requirements across the site and within WCT. Documentation Is accountable for the Production Records produced by their Manufacturing Sr. Managers, Managers and WCT members. Performs batch record reviews (BRR) or Electronic Batch Record review by exception. Ensures that all documentation produced by their Sr. Managers, Managers and WCTs follows the ALCOA+ principles. Ensures the documentation produced by their Sr. Managers, Manufacturing Managers and WCT members is right first time, and all records and logbooks are complete and accurate. Addresses all major documentation issues and establishes strategies that reduce documentation errors within their WCT. Process Expertise Supports Material Review Board (MRB) data collection and provides process expertise when required to support the MRB decision making process. Provides weekend coverage for manufacturing operations and is senior leadership support for any technical or manufacturing issues during weekend coverage. Continues to develop expertise in the field of CAR
T Manufacturing and regulatory requirements that pertain CAR T manufacturing. Resource Management Is responsible to hire personnel that meet job description criteria and BMS values and sustain the manufacturing culture and that meet budgetary and fiscal requirement. Monitor and maintain the facility resources to ensure calibrations are met, periodic maintenance criteria are met, and facility designs support continuing growth and operational needs for the manufacturing team. Manage and monitor inventory cycle counts during supply shortages and proactively control usage rate. Priorities Sets their Sr. Managers, Managers and 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. Capable of managing multiple projects and exceed or at a minimum meet in delivery against deadlines. Training Ensures that their Manufacturing Managers and their WCTs have the appropriate level of training necessary for CAR-T GMP manufacturing in a multi-product commercial facility. Is responsible to maintain their Manufacturing Sr. Managers, Managers, themselves, and WCTs training compliance at the required 100% on-time completion rate. Ensures that their Manufacturing Sr. Managers, Managers and 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 Manufacturing Sr. Managers, Managers and 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. Actively identifies training needs to increase compliance or technical knowledge and proactively work with the Training & Learning Organization (TLO) to deliver those programs. Team Building and Development Has proven capability to lead large diverse teams of approximately 100 personnel, supports a diverse thought process, encourages open communication and learning culture. Is responsible to build high performing WCTs comprising of Manufacturing Sr. Managers, Managers, 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 with urgency. 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 Manufacturing Sr. Manager to mentor, develop and motivate them. Provides periodic 1 over 1 meeting with Managers, Supervisors, Team Leads and WTC members to remain engaged with the team. Cascades relevant company information and takes time to help team members with their professional development including seeking out potential career development opportunities. Creates and maintains 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, Manufacturing Science & Technology, QC Laboratories, QA Doc Control, Training & Learning Organization, Global manufacturing departments, Global Quality and Global Manufacturing Science & Technology teams to sustain, improve, or maintain compliant manufacturing processes. Deviations Leads troubleshooting activities for their WCTs and is a Deviation Business Process Owner (BPO) or Area Manager Approval or Business Technical Approver
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. 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 Associate Director, Value Stream CAR T Manufacturing role is to manage and provide oversight of a team of Manufacturing Sr. Managers, Managers, and their Work Centered Teams (WCT) operating in shifts over a 24/7 schedule whose primary responsibility is the execution of Cell Therapy manufacturing processes, maintaining a culture of safety, compliance, innovation, and Continuous Improvement within the Manufacturing Operations function. Shift Available: Tuesday - Saturday, Onsite Afternoon Shift, 3 p.m. - 11:30 p.m. Responsibilities
Values Leads by example and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion. Leads with empathy while maintaining team accountability. Able to achieve results while creating an engaging, accountable, and learning culture. GMP Is accountable to ensure their Manufacturing Sr. Managers, Managers and 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). Responsible to own, review, author, or approve SOP, WI, master batch records. Responsible for setting strategic direction for the WCT while maintaining or exceeding compliance, budgetary, safety, and technical requirements. Has direct experience and success with Health Authorities and is capable to defend CAR-T manufacturing processes. Provides compliant solutions to technical issues or for continuous improvement programs. Develop and deliver against project plans that support technical transfers, APS, new equipment installations. Support and approve technical documents for the IQ/OQ/PQ, UAT Testing, and other equipment or process enhancements. Safety Takes personal responsibility to work safely and to ensure their managers and 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. Conducts monthly safety inspections and proactively partners with the EHS team for safety updates, initiatives, or trainings. Provides support for any safety inspections (internal or external) as requested. Acts as a Safety Change Agent supporting safety initiatives and requirements across the site and within WCT. Documentation Is accountable for the Production Records produced by their Manufacturing Sr. Managers, Managers and WCT members. Performs batch record reviews (BRR) or Electronic Batch Record review by exception. Ensures that all documentation produced by their Sr. Managers, Managers and WCTs follows the ALCOA+ principles. Ensures the documentation produced by their Sr. Managers, Manufacturing Managers and WCT members is right first time, and all records and logbooks are complete and accurate. Addresses all major documentation issues and establishes strategies that reduce documentation errors within their WCT. Process Expertise Supports Material Review Board (MRB) data collection and provides process expertise when required to support the MRB decision making process. Provides weekend coverage for manufacturing operations and is senior leadership support for any technical or manufacturing issues during weekend coverage. Continues to develop expertise in the field of CAR
T Manufacturing and regulatory requirements that pertain CAR T manufacturing. Resource Management Is responsible to hire personnel that meet job description criteria and BMS values and sustain the manufacturing culture and that meet budgetary and fiscal requirement. Monitor and maintain the facility resources to ensure calibrations are met, periodic maintenance criteria are met, and facility designs support continuing growth and operational needs for the manufacturing team. Manage and monitor inventory cycle counts during supply shortages and proactively control usage rate. Priorities Sets their Sr. Managers, Managers and 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. Capable of managing multiple projects and exceed or at a minimum meet in delivery against deadlines. Training Ensures that their Manufacturing Managers and their WCTs have the appropriate level of training necessary for CAR-T GMP manufacturing in a multi-product commercial facility. Is responsible to maintain their Manufacturing Sr. Managers, Managers, themselves, and WCTs training compliance at the required 100% on-time completion rate. Ensures that their Manufacturing Sr. Managers, Managers and 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 Manufacturing Sr. Managers, Managers and 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. Actively identifies training needs to increase compliance or technical knowledge and proactively work with the Training & Learning Organization (TLO) to deliver those programs. Team Building and Development Has proven capability to lead large diverse teams of approximately 100 personnel, supports a diverse thought process, encourages open communication and learning culture. Is responsible to build high performing WCTs comprising of Manufacturing Sr. Managers, Managers, 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 with urgency. 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 Manufacturing Sr. Manager to mentor, develop and motivate them. Provides periodic 1 over 1 meeting with Managers, Supervisors, Team Leads and WTC members to remain engaged with the team. Cascades relevant company information and takes time to help team members with their professional development including seeking out potential career development opportunities. Creates and maintains 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, Manufacturing Science & Technology, QC Laboratories, QA Doc Control, Training & Learning Organization, Global manufacturing departments, Global Quality and Global Manufacturing Science & Technology teams to sustain, improve, or maintain compliant manufacturing processes. Deviations Leads troubleshooting activities for their WCTs and is a Deviation Business Process Owner (BPO) or Area Manager Approval or Business Technical Approver