Manufacturing Associate, Liso - cel CAR-T - Summit West NJ

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.
• Supporting manual and electronic batch record executions, deviation investigations, and closure of CAPAs.
• Maintaining 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.

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.

Qualifications

• Available to work OT when business requires.
• Willing to work staggered day shift hours.