Senior Director, Value Stream 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 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 Senior Director, Value Stream CAR-T Manufacturing Operations will support clinical and commercial manufacturing in the Summit West CAR T facility. The Senior Director will also support capacity increase initiatives including Right First Time, implementation of new technology, and ensuring trained personnel are available to support capacity ramps to serve more patients and enable franchise growth. This role will be a key leader in site manufacturing operations and will be responsible for leading a multilayered 24/7 manufacturing team of ~350-400 employees.
The Senior Director will also serve as the delegate for the Executive Director, Cell Therapy Operations and support leadership of the value stream.
Duties and Responsibilities:
Direct and manage the CAR-T Manufacturing team in one of the Value Streams. This includes:
- Hiring, mentoring, and developing exceptional people, conducting performance reviews, and identifying opportunities for career growth for Directors, Associate Directors, Senior Managers, Managers, and Associates.
- Directly supervising up to 5 Directors/Associate Directors
- Implementing organizational design and driving change
- Championing a culture of exceptional teamwork, accountability, continuous improvement, and communication across the organization and multiple sites within CTDO.
- Ensuring staff at all levels have and maintain the appropriate level of training necessary for CAR T cGMP manufacturing in a multi-product commercial facility.
- Building effective cross-functional relationships with Quality, Supply Chain, MS&T, EHS and Facilities.
- Ensuring a culture that embraces safety in the work environment and safety of the patients through compliance with company procedures, policies, and cGMP requirements.
Oversee operation of the CAR-T Manufacturing suites in the Value Stream. This includes:
- Ensuring safe, quality, and compliant operations in all 3 process steps – selection, activation, and harvest for the final drug product
- Establishing goals, tracking and reporting KPIs, and driving continuous improvement through innovation and implementing lean manufacturing initiatives.
- Implementing operating manufacturing systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
- Ensuring schedules of the people, facility, equipment, materials, and documents are established and maintained to support the expected capacity for the Value Stream
- Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
- Ensuring on time closure and effectiveness of deviation investigations, CAPAs, and change controls.
- Championing inspection readiness efforts and initiatives for Right First-Time manufacturing.
- Establishing team policies, organizational structure, shift structure, and career ladders for Associates, Team Leaders and Managers dedicated to the Value Stream suites.
- Reviewing and approving documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports.
- Up to 10% travel may be required.
Required Competencies: Knowledge/ Skills, and Abilities:
- Advanced understanding and experience with CAR T manufacturing including cell culture, cryopreservation, purification, and aseptic processing.
- Knowledge of cGMP/FDA regulated industry, including direct experience with ex-US Health Authorities (EMA, Health Canada, PDMA) and inspections, preferably for commercial CAR T products.
- Ability to work effectively in cross-functional teams to deliver results and meet business objectives.
- Experience with reviewing and approving SOPs, Batch Records, Change Controls, deviations and CAPAs.
- Strong background in training and compliance with demonstrated ability to influence and negotiate to meet business requirements.
- Background to include an understanding of biology, chemistry, medical or clinical practices
- Previous experience managing, coaching, and providing direction to manufacturing and technical staff in a commercial biopharmaceutical manufacturing setting.
- Understanding and proficiency of lean manufacturing concepts, such as tiered management, problem solving, level loading, kaizens, coaching, etc.
Qualifications and Requirements:
- Bachelor’s degree in relevant science or engineering discipline required.
- Advanced degree in science, engineering, MBA, or supply chain preferred.
- 15+ years’ experience with cGMP commercial manufacturing; biologics and/or commercial cell therapy operations preferred
- 8+ years’ experience supervising staff at the Associate Director or Director level.
- Demonstrated track record supporting commercial licensure of new facilities or products preferred; experience with CAR T products is a plus.
- International experience preferred.
- Knowledge of Lean Manufacturing principles required.
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 firstname.lastname@example.org. 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.
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.
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.
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.
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 email@example.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.
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