Associate Specialist, Value Stream Cryo Operations - Summit West, NJ

Job Description

This Specialist, Value Stream Cryo Operations role is located in Summit, NJ, and supports cryopreservation, handling, and storage of manufacturing patient materials at the CAR‑T manufacturing facility. The position is available to Veterans, transitioning military, National Guard and Reserve members, military spouses, wounded warriors, and their caregivers.

Shift: Sunday‑Wednesday (optional Wednesday off), Onsite Night Shift, 5 p.m. – 5:30 a.m.

• Handling patient material throughout cryopreservation, storage, distribution, transfer, and disposal.
• Maintaining sample tracking and chain‑of‑custody records in accordance with GMP requirements and written procedures.
• Ensuring obsolete or expired samples and materials are destroyed and disposed of according to written procedures.
• Performing sample queries and periodic storage reports, as required.
• Assisting management with investigations and deviations related to sample management.
• Collaborating with other departments to identify and implement process efficiencies.
• Maintaining metrics for the Value Stream Cryo Operations group.
• Facilitating cold‑chain transfers of material, as required.
• Performing tasks for Cell Therapy products to support product Value Stream outputs according to cGMPs, approved SOPs, and WIs.
• Maintaining timing according to the production schedule to ensure on‑time cryopreservation support.
• Cryopreserving patient material daily, storing, and managing inventory in LN₂ storage locations.
• Supporting manual and electronic batch record executions, deviation investigations, and closure of CAPAs.
• Ensuring all documentation is correct and addressing procedural/documentation errors expeditiously and effectively.
• Working with management to ensure adequately trained personnel are available for all activities.
• Recording patient material handling data and information in a clear, concise format according to proper GDPs.
• Problem‑solving with minimal supervision.
• Working in a team‑based, cross‑functional environment to complete tasks required by the shift schedule.
• Performing other duties as assigned, as necessary.

• Experience with cold‑chain sample storage and transfer.
• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills.
• General understanding of cGMPs.
• Technical writing capability.
• Proficiency in MS Office applications.
• Inventory control and/or management.
• Background including understanding of biology, chemistry, medical, or clinical practices.
• Availability to work overtime when business requires.
• Willingness to work staggered day shift hours.

• Bachelor’s degree with no prior experience.
• OR Associate/Medical Technical degree with 0–2 years of manufacturing or operations experience.
• OR High School diploma/GED with 2–4 years of manufacturing or operations experience.

• Must be able to stand or walk for extended periods.
• Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets, requiring appropriate PPE (e.g., safety shoes, glasses, aprons, face shields, PAPR, lab coats, gowns, hairnets, gloves, and hearing protection).
• Required to carry or lift up to 30 pounds (15 kg) several times a day.
• Required to push or pull up to 50 pounds (25 kg) several times a day.
• Work may involve strong magnets and vapor‑phase liquid nitrogen exposure.
• Must work in a BSL 2 / ML 1 environment handling human blood components.
• Must be able to work assigned shifts (Day, Evening, Night, Weekends, and/or Holidays).

Summit West, NJ: $34.66 – $42.00 per hour for full‑time employees. The starting compensation range is listed above. Additional incentive cash and stock opportunities (based on eligibility) may be available. Final compensation is determined based on demonstrated experience.