Senior Specialist, CAR-T Lifecycle Management

Senior Specialist, CAR-T Lifecycle Management Shifts Available:

• Monday–Friday, Hybrid Day Shift, 8 a.m.–5 p.m.

• Provide on-the-floor process support for manufacturing activities.
• Develop inputs into electronic batch record/process automation to advance manufacturing strategy.
• Participate on project teams (schedules, technical execution, presentations to stakeholders/senior management).
• Support change and process improvement initiatives; foster strong inter-team relationships.
• Interface with operations as process SME; monitor/analyze/optimize end-to-end process and permanently resolve production issues.
• Execute test plans and risk mitigation (e.g., root cause analysis, CAPAs).
• Organize, record, and maintain experimental data.
• Stay current with industry trends/standards (e.g., PDA, ISPE) and participate in best-practice forums.
• Assist with revisions to technical documentation (investigations, changes, SOPs, batch records).
• Interact with Validation, Development, Operations, QA, and Regulatory; attend routine plant operating meetings.
• Support health authority inspections; train and mentor junior associates.

• Knowledge of cGMPs and multi‑national biopharmaceutical regulations (cell therapy major plus).
• Single‑use technologies, closed systems, cold chain/cryogenic technologies.
• Hands‑on CAR‑T or biopharma manufacturing/QC preferred; strong communication skills; strategic thinking.

• Bachelor’s degree (science/engineering preferred).
• 5+ years cGMP experience in Cell Therapy.
• 2+ years process engineering hands‑on.
• 2+ years direct project management.

• 60–75% office; 25–40% manufacturing/lab; occasional NJ travel; flexibility for extended hours/weekends/holidays.

• Base pay range: $81,920–$99,271 (Summit West, NJ, US). Eligible for comprehensive benefits and (U.S. exempt) Flexible Time Off plus 11 paid holidays.