Specialist

Position Title: Associate Specialist, Value Stream Cryo Operations

Department: Value Stream Cryo Operations

Duration: 06 Months
Location: Summit West, S-12, 07901

PURPOSE AND SCOPE OF POSITION:

Specialist, Value Steam 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.



Responsible for cryopreservation and management of including:

• 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 identity and implement process efficiencies.
• Maintaining metrics for the Value Stream Cryo Operations group.
• Facilitating cold chain transfers of material, as required.
• Performs 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).
• Maintains timing according to the production schedule to ensure on-time
• Cryopreservation support.
• Cryopreserve Patient material daily, store and manage Inventory of material in LN2 storage locations.
• Supports manual and electronic batch record executions, deviation investigations, and closure of CAPAs.
• Maintains timing according to the production schedule to ensure on-time logistics.
• Ensures all documentation is correct and addresses procedural/documentation errors expeditiously and effectively.
• Work with management to ensure adequately trained personnel are available to perform all Value Stream Cryo Operations activities.
• Records patient material handling data and information in a clear, concise, format according to proper GDPs.
• Able to problem solve with minimal supervision.
• Works in a team based, cross-functional environment to complete tasks required by shift schedule.
• Other duties may be assigned, as necessary.
• Available to work OT when business requires.
• Willing to work staggered day shift hours.

Education and Experience:

• 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.

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