Job Details
NIGHT SHIFT: Sr. Manager - CAR T Manufacturing
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.
The Sr. Manager, CAR-T Manufacturing Operations will support the scale-up and commercial licensure of the Summit West CAR-T facility. In addition, the Sr. Manager will be responsible for the people manufacturing both clinical and commercial product. This person will be a key leader responsible for GMP operations and will serve as a member of the S12 Manufacturing Leadership Team. This position will manage the Weeknight Shift, operating Monday through Friday with shift coverage from 3:30 PM to 1:00 AM. Weekend coverage as needed. Start and end times for this position are subject to change based on business demands.
Duties and Responsibilities:
Establishes and manages the S12 CAR-T Weekday Manufacturing team. This includes:
- Hiring, mentoring and developing exceptional people. This includes conducting performance reviews and identifying opportunities for career growth for supervisors and associates.
- Championing a culture of exceptional teamwork and communication across the organization.
- Ensuring people have and maintain the appropriate level of training necessary for CAR-T GMP 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 the safety of the patients by compliance with company procedures and policies, and cGMP requirements.
Participates in the scale-up and operation of the S12 CAR-T Manufacturing Plant. This includes:
- Establishing department goals, tracking and reporting KPIs, and driving continuous improvement through innovation and implementing lean manufacturing initiatives.
- Implementing and 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 of the facility for multiple CAR-T products.
- Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
- Ensuring on time closure of deviations, 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 and Team Leaders.
- Reviewing and approving documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports.
Education & Experience:
- Bachelor’s degree in relevant science or engineering discipline, or equivalent in work experience. Advanced degree preferred.
- Knowledge of Lean Manufacturing principles required.
- 7-10 years of experience in cGMP biologics manufacturing, experience in cell therapy manufacturing preferred.
- 5+ years supervising staff in a management role.
Required Competencies:
- Advanced understanding of cell culture, cryopreservation, purification, and aseptic processing or lab techniques
- Knowledge of cGMP/FDA regulated industry
- Technical writing capability and experience with writing and approving SOPs, Batch Records, Change Controls, deviations and CAPAs.
- Proficient in MS Office applications
- Background to include an understanding of biology, chemistry, medical or clinical practices
- Previous experience managing, coaching, and providing direction to manufacturing staff
Pre-requisites: Manufacturing Supervisor or equivalent experience
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.
BMSCART
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and 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.
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 approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.