Associate Specialist, Value Stream Cryo Operations

Quad 4:
Thursday–Saturday, alternating Wednesdays 5PM–5:30AM

Associate Specialist, Value Stream Cryo Operations is responsible for cryopreservation, movement, storage, and control of patient materials used in manufacturing, and support of liquid nitrogen storage tanks and equipment at the CAR T manufacturing facility in Summit, NJ.

• Cryopreserve and manage patient materials (processing, storage, transfer, distribution, disposal).
• Maintain sample tracking and chain of custody in compliance with GMP and written procedures.
• Dispose of expired/obsolete materials per approved procedures.
• Perform sample queries, inventory tracking, and periodic storage reporting.
• Support investigations, deviations, and CAPA closure related to cryopreservation/sample processes.
• Execute manual and electronic batch records per cGMPs, SOPs, and work instructions.
• Maintain on-time cryopreservation and logistics aligned to production schedules.
• Manage LN2 storage inventory and support daily cryopreservation operations.
• Collaborate cross‑functionally to improve processes and drive efficiencies.
• Ensure accurate, complete, compliant documentation (GDP); resolve documentation errors promptly.
• Partner with management to ensure training/readiness of personnel.
• Operate in a team‑based, cross‑functional environment with minimal supervision.
• Support flexible scheduling (overtime/staggered shifts) as needed.

• Bachelor’s degree
• OR
• Associate degree/Medical Technical degree with 0–2 years of manufacturing/operations experience
• OR
• High school diploma/GED with 2–4 years of manufacturing/operations experience

• Knowledge of cGMP and FDA-regulated environments; understanding of cGMP requirements
• Basic math; technical writing
• Microsoft Office proficiency
• Inventory control/management experience
• Background in biology, chemistry, or medical/clinical practices (plus)

• $34.66–$42.00 per hour (Summit West, NJ)
• Health coverage; wellbeing support; 401(k); life/disability/insurance options.
• Paid Time Off: flexible time off (unlimited, manager approval, 11 holidays) or 160 hours annual paid vacation + 11 holidays + 3 optional holidays (by eligibility).