About this role
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.
This is work that transforms the lives of patients, and the careers of those who do it.
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 Senior Specialist, CAR-T Lifecycle Management is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. Potential areas of responsibility include managing multidisciplinary projects aimed at improving the process, and developing input into process automation systems to deliver advances in manufacturing strategy. These areas include creation/revision of engineering documentation and management of external resources (e.g. engineers and/or scientists) required to support the production of personalized cell therapy products.
Cross-functional collaboration with SMEs from the Development Group, Manufacturing Group, Supply Chain Group, and Quality Group is essential to ensuring technical support is delivered to a rapidly growing CAR-T manufacturing organization.
Shifts Available
Monday - Friday, Hybrid Day Shift, 8 a.m. - 5 p.m.
Responsibilities
Provide on the floor process support for ongoing manufacturing activities when needed.
Develop inputs into electronic batch record/process automation technologies to advance the manufacturing strategy
Participate on project teams to help prepare project schedules, execute technical projects and develop presentations to disseminate results to project stakeholders and senior management.
Support the change initiatives and the implementation of process improvement initiatives.
Foster strong inter-team relationships to achieve common project goals.
Interface with operations and serve as process SME
Support monitoring, analyzing, and optimizing the end-to-end process and anticipate and permanently resolve issues that may arise during production.
Execute test plans and other risk mitigation exercises as part of investigations (e.g. Root cause analysis and CAPAs).
Organize, record and maintain experimental data.
Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
Assist with revisions of the content of technical documentation (e.g. investigations, changes, SOPs and batch records).
Interact with other teams including Validation, Development, Operations, QA and Regulatory.
Participate in routine plant operating meetings.
Proven ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
Support health authority inspections
Ability to set priorities, manage timelines and effectively react/manage changing priorities.
Ability to work with management (global and site) and support corporate and departmental goals.
Ability to communicate honestly, transparently, and effectively with peers, department management and cross functional peers.
Hands on experience preferred with CAR T or biopharmaceutical manufacturing and Quality Control. Proven delivery of complex investigation reports.
Ability to train and mentor junior associates to foster and develop their expertise.
Knowledge & Skills
Knowledge of cGMPs and multi-national biopharmaceutical regulations. Cell therapy experience is a major plus.
Knowledge of the relationship between manufacturing processes, ERP, and MES a major plus.
Must have excellent organization skills and ability to handle multiple tasks.
Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies.
Possess strong verbal/written communication skills; to in presentation to Executive Leadership Team.
Ability to think strategically and to translate strategy into actions.
Minimum Requirements
Bachelor’s Degree required (science or engineering is preferred).
5+ years of cGMP experience working in Cell Therapy.
2+ years with Process Engineering hands-on activities.
2+ years with direct project management experience.
Working Conditions
The incumbent will be working 60% to 75% of the time in an office environment.
The incumbent will be working 25% to 40% of the time in a manufacturing and/or laboratory setting.
The incumbent may travel between NJ sites for training, meetings or corporate events on occasion.
The incumbent will need to have flexibility to work extended hours (>8 hours/day), weekend and/or holidays when required to meet deadlines.
BMSCART, #LI-Hybrid
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview
Summit West - NJ - US: $81,920 - $99,271