Senior Specialist, CAR-T Lifecycle Management

Biopharma Careers; Summit West (CA); Hybrid; USD 82,000 - 99,000; Full time

Benefits offered by this job

Health benefits

Flexible time off

Paid holidays

Job summary

Bristol Myers Squibb in Summit West, NJ is seeking a Senior Specialist, CAR-T Lifecycle Management to support production of personalized cell therapy products for clinical trials and commercial supply. You will lead projects to improve processes and contribute to automation strategies, working with SMEs across Development, Manufacturing, Supply Chain and Quality.

This role requires 5+ years of cGMP experience in cell therapy, hands-on process engineering, and strong project management.

Qualifications

• 5+ years of cGMP experience in cell therapy.
• 2+ years with Process Engineering hands-on activities.
• 2+ years with direct project management experience.

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 prepare project schedules, execute technical projects and disseminate results to 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
• Monitor, analyze, and optimize end-to-end processes and resolve production issues.
• Execute test plans and risk mitigation activities (e.g., CAPAs).
• Organize, record and maintain experimental data.
• Stay current with industry trends (PDA/ISPE) and participate in best-practice forums.
• Assist revisions of technical documentation (investigations, changes, SOPs, batch records).
• Interact with Validation, Development, Operations, QA and Regulatory teams.
• Participate in routine plant operating meetings.
• Support health authority inspections.

Skills

cGMPs

Cell therapy

ERP/MES knowledge

Single-use tech

Communication

Strategic thinking

Executive presentation

Education

Bachelor’s degree in science or engineering

Job description

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

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 at https://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 https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodations/adjustments prior to accepting a job offer. If you require reasonableaccommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: 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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1604191 : Senior Specialist, CAR-T Lifecycle Management