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

Military Spouse Corporate Career Network•Summit West, NJ

8d•Onsite

About The Position

Bristol Myers Squibb is seeking an Associate Specialist for Value Stream Cryo Operations at their Summit West, NJ facility. This role is responsible for the cryopreservation, movement, storage, and control of manufacturing patient materials, as well as supporting Liquid Nitrogen storage tanks and equipment. The position involves handling patient materials throughout their lifecycle, maintaining accurate records in accordance with GMP requirements, and ensuring proper disposal of obsolete materials. The specialist will also assist with investigations, collaborate with other departments for process improvements, and maintain metrics for the Cryo Operations group. This role performs tasks for Cell Therapy products to support value stream outputs according to cGMPs, SOPs, and WIs, ensuring timely cryopreservation and logistics support. The specialist will support batch record execution, deviation investigations, and CAPA closure, ensuring all documentation is accurate and errors are addressed promptly. They will also work with management to ensure adequate training for personnel and record patient material handling data according to GDPs. The role requires problem-solving skills with minimal supervision and collaboration in a team-based, cross-functional environment.

Requirements

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.
Available to work OT when business requires.
Willing 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.

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 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.