Associate Specialist, Value Stream Cryo Operations

About the role

At Bristol Myers Squibb, the Specialist, Value Stream Cryo Operations plays a crucial role in 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.

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.
• Aiding 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.
• Recording 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.

Knowledge & Skills

• Experience with cold chain sample storage and transfer.
• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills.
• Technical writing capability.
• Proficient in MS Office applications.
• Inventory control and/or management.
• Understanding of biology, chemistry, medical or clinical practices.

Minimum Requirements

• 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.

Working Conditions

• 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).
• Must be able to work in a BSL2 / ML1 work environment handling human blood components.
• Must be able to work in areas with exposure to vapor phase liquid nitrogen.
• Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays).

Compensation Overview

The starting compensation range(s) for this role are 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, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.