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 rich in diversity. 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 inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

PURPOSE AND SCOPE OF POSITION:

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.

The scope of the Associate Director Manufacturing role:

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.

REQUIRED COMPETENCIES:

Education & Experience:

• 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 9 years of relevant manufacturing experience.
• Minimum of 8 years leadership experiences including the management of direct reports required.

Knowledge, Skills, and Abilities:

• Extensive knowledge of EHS and cGMPs, ATMPs, 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),
• Strong People Manager capabilities with an aptitude to motivate large teams for the delivery of excellent performance.

Behaviors:

• Highly organized and disciplined in delivery of exceptional results.
• Easily approachable and maintains a desire to build and foster relationships while working through challenges/opportunities.
• Strategically resolves manufacturing and technical issues while maintaining / meeting compliance requirements.
• Identify and/or implement agile solutions that lead the organization to higher production, compliance, or safety capabilities.
• Capable of connecting business goals with day-to-day operations and providing direct and clear objectives to Sr. Managers, Managers, and WCT members.
• 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 look into 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 ones 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

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.

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.

Why You Should Apply:

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or 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.

If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

BMSCART

#LI-ONSITE

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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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 will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.