CAR-T Lifecycle Manager: Process & Manufacturing

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

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.