Associate Specialist, Value Stream Cryo Operations

Shift Available

• Sunday – Wednesday (with e/o Wednesday off), Onsite Night Shift, 5 p.m. – 5:30 a.m.

• Handling patient material throughout the material cryopreservation, storage, distribution, transfer, and disposal.
• Maintaining sample tracking and chain of custody records in accordance with GMP requirements and written procedures.
• Ensuring that 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 Current Good Manufacturing Practices (cGMPs) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Maintaining timing according to the production schedule to ensure on‑time cryopreservation support.
• Cryopreserving patient material daily, storing and managing inventory of material in LN2 storage locations.
• Supporting manual and electronic batch record executions, deviation investigations, and closure of CAPAs.
• Ensuring all documentation is correct and addresses procedural/documentation errors expeditiously and effectively.
• Working with management to ensure adequately trained personnel are available to perform all Value Stream Cryo Operations activities.
• Recording patient material handling data and information in a clear, concise format according to proper GDPs.
• Being able to problem‑solve with minimal supervision.
• Working in a team‑based, cross‑functional environment to complete tasks required by shift schedule.
• Other duties may be 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 in biology, chemistry, medical or clinical practices.
• Availability to work overtime when business requires.
• Willingness to work staggered day shift hours.

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

• Must be able to stand/walk for extended periods of time.
• Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets (as assigned), which require gowning and personal protective equipment (PPE) including safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves and hearing protection.
• Required to carry and/or lift up to 30 pounds (15 kg) several times a day while handling production equipment and/or materials.
• Required to push and/or pull up to 50 pounds (25 kg) several times a day while handling production equipment and/or materials.
• Work in areas that may have strong magnets.
• Must be able to work in a BSL‑2/ML‑1 environment handling human blood components.
• Work in areas with exposure to vapor‑phase liquid nitrogen.
• Must be able to work assigned shift (Day, Evening, Night, Week‑ends and/or Holidays).

Summit West – NJ – US: $34.66 – $42.00 per hour.

The starting compensation range for this role is listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, location, work schedule, job‑related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

• Health Coverage:
  Medical, pharmacy, dental and vision care.
• Wellbeing Support:
  Programs such as BMS Well‑Being…