Cryo Operations Specialist — Precision Cold-Chain

Spectraforce Technologies; Summit (NJ); On-site; USD 30,307 - 46,838; Full time

Job summary

Spectraforce Technologies in Summit, NJ, seeks an Associate Specialist to support Value Stream Cryo Operations at the CAR-T manufacturing facility. You will cryopreserve patient materials, manage LN2 storage, and ensure timely sample handling, custody, and documentation in a GMP environment.

The role requires 0–2 years of related experience or equivalent education, willingness to work Wed-Sat shifts with overtime, and collaboration across teams to maintain cold chain integrity and accurate batch

Qualifications

• Bachelor's or Associate/Medical Tech degree with 0–2 years of manufacturing or operations experience.
• Or High School diploma/GED with 2–4 years of manufacturing or operations experience.
• Experience with cold chain sample storage and transfer.
• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills.
• Technical writing capability.
• Proficient in MS Office applications.
• Inventory control and/or management.

Responsibilities

• Handle patient material throughout cryopreservation, storage, distribution, transfer, and disposal.
• Maintain sample tracking and chain of custody records per GMP procedures.
• Ensure obsolete or expired samples are destroyed per procedures.
• Perform sample queries and periodic storage reports as required.
• Assist management with investigations and deviations related to sample management.
• Collaborate across departments to improve process efficiencies.
• Maintain metrics for the Value Stream Cryo Operations group.
• Facilitate cold chain transfers of material as required.
• Perform tasks for Cell Therapy products to support value stream outputs per cGMP SOPs/WIs.
• Align timing with production schedule for on-time Cryopreservation support.
• Cryopreserve patient material daily; manage LN2 storage inventory.
• Support batch record executions, deviation investigations, CAPA closures.
• Ensure documentation is correct and address errors expeditiously.
• Work with management to ensure adequately trained personnel available.
• Record patient material handling data in clear, proper GDP format.
• Problem-solve with minimal supervision in a team-based environment.
• Overtime may be required; work staggered day shift hours.

Skills

Cold chain storage

CGMP/FDA knowledge

Mathematical basics

Technical writing

MS Office

Inventory control

Biology/Chemistry background

Education

Bachelor's or Associate/Medical Tech degree

HS diploma with 2–4 years experience

Job description

Spectraforce Technologies in Summit, NJ, seeks an Associate Specialist to support Value Stream Cryo Operations at the CAR-T manufacturing facility. You will cryopreserve patient materials, manage LN2 storage, and ensure timely sample handling, custody, and documentation in a GMP environment.

The role requires 0–2 years of related experience or equivalent education, willingness to work Wed-Sat shifts with overtime, and collaboration across teams to maintain cold chain integrity and accurate batch