Bristol-Myers Squibb
Manager, Cell Therapy Supply Chain
7 days agoWhat's your preference?
Job Description
- Req#: R1591629
- Final storage of finished Cell Therapy drug product into cryogenic storage
- Receipt and processing of incoming patients’ apheresis material
- Packaging of finished drug product into cryogenic shipper for shipment to patient
- Performance of material kitting operations to ensure continuous supply of raw materials and consumables to support the manufacture of Cell Therapy products
- Support with SAP transactions and workflows with direct and indirect impact on Manufacturing
- Execute against scheduled activities and make decisions and allocate resources accordingly within and across departments.
- Provide management and oversight to floor operations team during second shift
- Perform and oversee the receipt and processing of incoming patient apheresis material with corresponding documentation in SAP and other electronic systems
- Perform and oversee the execution of the drug product put-away to final cryogenic storage location in SAP and other electronic systems
- Perform and oversee the packaging of final drug product into cryogenic shipper for shipment to patient with corresponding documentation in SAP and other electronic systems
- Perform and oversee execution of kit-building and material delivery to support manufacturing with corresponding documentation in SAP and other electronic systems
- Triage quality events with team and Quality Assurance to assess deviation requirement, impact, and forward processing decision; escalate as needed to drive resolution
- Ensure proper training for self and team against required unit operation-specific training curricula including SOP, policy, protocol, on-the-job training, health exam, etc.
- Manage implementation and maintenance of appropriate training curricula across team
- Maintain all operating spaces (suites, airlocks, corridors, workstations) in a clean and orderly manner per SOP and always ensure audit readiness. If deficiency is observed, the expectation is to take action to resolve or develop proposal to review with manager to implement solution.
- Lead by example and set expectation for Safety and Quality Culture; promote a mindset of ‘Right First Time’.
- Ensure your and your team’s adherence to all applicable policies, SOPs, and instructional documentation in accordance with BMS expectations
- Lead and manage the development of corrective and preventative actions, deviation responses, and investigations
- Identify opportunities for continuous improvement and drive efficiency in the process. Build business case and make proposal to streamline approval and implementation of the initiative.
- Make use of and promote the use of Tier meetings and other existing business processes to drive accountability, manage metrics, and cascade/escalate issues to and from your team
- Develop a mindset of continuous improvement within your team
- Hire, mentor, and develop exceptional people: Conduct performance reviews and identify opportunities for career growth for members of team as applicable
- Create an environment of teamwork, open communication, and a sense of urgency.
- Additional duties, tasks, and responsibilities as assigned by the Supply Chain department.
- ERP experience; preferably in SAP Extended Warehouse Management (EWM) transactions
- CGMP experience in the biotech industry; preferably Cell Therapy
- Demonstrated leadership capabilities and people management experience
- Proven experience in triage of events and execution of deviations, CAPA, and other workflows in the Quality Management System (QMS); preferably in Infinity
- Prior experience in kitting and delivery of raw materials and consumables to Manufacturing
- Prior experience in handling of cold chain biological materials; prior experience with cryogenic storage (LN2) is preferred
- Experience with health authorities (i.e., FDA) for audit support
- Experience and familiarity with electronic systems including SAP, and manufacturing execution systems (MES) including Syncade and DeltaV
- Safety and Quality mindset; proven ability to build a culture around these values and to communicate critical information clearly and in a timely manner to team and to leadership as needed
- Ability to independently determine business priority and direct resources to where the need is on the floor. This will require coordination with other managers and effective communication and assignment of work.
- Bachelor's degree in a relevant science or engineering discipline. An advanced degree is a plus.
- 5+ years of experience in CGMP manufacturing within a biopharmaceutical or cell therapy manufacturing environment
- 3+ years of experience with direct reports required.
- Health Authority interaction and audit experience; experience with FDA is preferred
- Experience working in an ERP system; SAP EWM is preferred
- Experience with electronic manufacturing execution system (MES); DeltaV and Syncade are preferred
- Familiarity with operation in classified spaces (i.e. CNC and Grade 8)
- Experience with Quality Management Systems; Infinity is preferred
- Experience in following, revising, and creating controlled documentation in a document management system
- Experience with handling patient biological materials and understanding of Chain of Identity (COI)
- Experience with material operations (i.e., material delivery, replenishment, kitting)
- Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time throughout the day. It is expected that at least 70% of the shift is spent on the floor where the operations are happening. Expectation for operators is at least 90% on the floor.
- Work will take place in classified and non-classified spaces.
- Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include but is not limited to safety shoes, safety glasses, aprons, face shields, lab coats, full full-body gowns, hairnets, gloves, and hearing protection in accordance with gowning protocol per grade level and safety requirements.
- Work will take place within one facility across several operational suites.
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 Manager, Cell Therapy Supply Chain is responsible for management and oversight of critical operations in direct support of the manufacture of Cell Therapy products in the Bristol-Myers Squibb, Devens Cell Therapy Facility.
This may include the following operations:
This is a direct people manager role where the manager will be accountable for their team’s execution of the activities described above. The hours of this role are 6 PM to 6 AM, therefore autonomy in decision-making, technical expertise, and leadership capability within a commercial CGMP manufacturing facility in the Biotechnology industry is required.
Shifts Available:
B2 – 6pm – 6am – Rotating Shift including Holidays and Weekends - Onsite
Responsibilities:
Floor Operations:
Quality, Compliance, Safety, and Integrity:
Operational Excellence and Continuous improvement:
Management and Development:
Knowledge and Skills:
Basic Requirements:
Working Conditions:
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.
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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/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
About the company
BMS' primary R&D sites are located in Lawrence, New Jersey, New Brunswick, New Jersey, and Redwood City, California; with other sites in Devens and Cambridge, Massachusetts, East Syracuse, New York, Braine-l'Alleud, Belgium, Tokyo, Japan, Bangalore, In...
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