Associate Director, CAR-T Manufacturing Operations

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 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 (BTA) for deviation approvals occurring for manufacturing.
• Maintains deviation metrics and ensures deviation awareness for the WCTs across all shifts, Pareto’s out worst or repeat causes of deviations and ensures close out of all deviations on time.
• Works proactively with their Manufacturing Sr. Managers, Managers and WCTs to reduce the number of deviations occurring and to eliminate repeat causes of deviations.
• Is accountable to drive continuous improvement to prevent repeat deviations.
• Reports out deviation progress, maintains their deviation metrics, Pareto’s out worst or repeat causes of deviations and closes out all deviations on time.
• Ensures their Manufacturing Sr. Managers and Managers maintain deviation closure rate (on-time – 2 days prior to due date).
• Provides reinforcement discussion or coaching as needed to build WCT expertise.

CAPAs, Change Controls & Projects

• Participates, facilitates, and drives meaningful CAPAs, Change Controls and Projects.
• Implements or holds Sr. Managers and Managers responsible for the implementation of CAPAs prior to due date.
• Participates in CAPA, Change Control, Capital meetings and defines, agrees, or owns CAPAs, Change Controls or capital projects for manufacturing.

Budgets

• Effectively controls expenses within their influence (OT, Supplies, T&E).
• Maintains approval rights for purchases to support daily operations. Complies with BMS fiscal and budgetary protocols and procedures.
• Develops metrics that demonstrate the meeting of budgets for their WCT.

Meetings

• Is responsible to facilitate and lead weekly Tier meetings using the site standard Tier meeting tools.
• Facilitate monthly Manufacturing Performance Review meetings.
• Is responsible to participate in the weekly Deviation, CAPA, and Change Control meetings to provide status updates on the quality records owned by them.
• Support the Investigational Review Board Meetings and provide endorsement to deviations.
• Attends the weekly WAM and the daily cross-functional manufacturing meeting providing summary of previous day activities, successes, or communicates equipment outages or processing delays.

Knowledge & Skills:

• 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. Green belt certified is a preference.
• Excellent communication skills (EN).

Basic 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.
• Minimum of 10 years of relevant pharmaceutical manufacturing experience with 2-3 years of clean room experience.
• Minimum of 5 years of direct leadership experiences is required.
• 5 years of regulatory audit experience is required.
• 2-3 years of working it and managing budgets (to include financial and headcount).
• 2-3 years of project management.
• Lean leadership experience. Green belt certification desired.

Working Conditions:

• 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.
• May require aseptic gowning.

The starting compensation for this job is a range from $159,490 to $193,300 plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers Site.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

BMSCART, #LI-Onsite

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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: https://careers.bms.com/california-residents/

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