Associate Specialist, Value Stream Cryo Operations

Job description

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. Our 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. Shift Available: Sunday - Wednesday (with e/o Wednesday off), Onsite Night Shift, 5 p.m. - 5:30 a.m. 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. Knowledge & Skills: 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. Minimum Requirements: High School Diploma required. Bachelor's or associate degree preferred. 0-1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant 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), which require gowning and personal protective equipment (PPE), including by not limited to: safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves, and hearing protection. Required to carry and/or lift up to 30 pounds / 15 kg, several times a day, while handling production equipment and/or materials. Required to push and/or pull up to 50 pounds / 25 kg, several times a day, while handling production equipment and/or materials. Work in areas that may have strong magnets. Must be able to work in a BSL2 / ML1 work environment handling human blood components. Work in areas with exposure to vapor phase liquid nitrogen. Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays). If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Summit West - NJ - US: $34.66 - $42.00per hour 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. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: 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. ​Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due