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:
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.
Summit West - NJ - US: $81,920 - $99,271
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:
Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings athttps://careers.bms.com/benefits
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at
