Associate Specialist, Value Stream Cryo Operations

About the position

The Specialist, Value Stream Cryo Operations is responsible for the Cryopreservation, movement, storage, control of manufacturing patient materials, and support of Liquid Nitrogen storage tanks and equipment at the CAR T manufacturing facility in Summit, NJ. This includes but is not limited to, cryopreservation, storage, inventory control, chain of custody, and material tracking.

Responsibilities

• 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 (cGMP's) 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.

Requirements

• Bachelor's degree
• 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.

Nice-to-haves

• Experience with cold chain sample storage and transfer.
• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills.
• General understanding of cGMPs.
• Technical writing capability.
• Proficient in MS Office applications.
• Inventory control and/or management.
• Background to include an understanding of biology, chemistry, medical or clinical practices is a plus.