Manufacturing Associate, CAR-T, Manufacturing 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. Manufacturing Associate, CAR-T, Manufacturing Operations (Harvest) is responsible for manufacturing human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable. Shifts Available: Quad 2: Sunday - Wednesday (e/o Wednesday off), Onsite Night Shift, 5 p.m. - 5:30 a.m. Quad 4: Wednesday - Saturday (e/o Wednesday off), Onsite Night Shift, 5 p.m. - 5:30 a.m. Responsibilities: Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation. Support deviation investigations and write ups as needed. Support on time closure of any assigned CAPAs within the designated shift. Aseptic technique and gowning is required for most activities: welding, connections, and transfers, at minimum. Aseptic ISO7/ISO5 qualification is required. Weighs and measures in-process materials to ensure proper quantities are added/removed. Adheres to the production schedule ensuring on-time, internal production logistics. Records production data and information in a clear, concise, format according to proper GDPs. Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements. Works in a team based, cross-functional environment to complete production tasks required by shift schedule. Motivated, team consciousness individuals are needed to fulfill job requirements. Become a SME and qualified trainer within a designated function of manufacturing. Supervision will be managed by the shift Supervisor or designated Team Lead. Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge. Performs other tasks as assigned: continuous improvement projects, inspection readiness, right first-time initiatives, etc. Ensures all documentation is correct and addresses procedural/documentation errors expeditiously and effectively. Records patient material handling data and information in a clear, concise, format according to proper GDPs. Able to problem solve with minimal supervision. Other duties may be assigned, as necessary. Available to work OT when business requires. Knowledge & Skills: Knowledge of cGMP/FDA regulated industry. Basic mathematical skills. General understanding of cGMPs. Technical writing capability. Proficient in MS Office applications. Background to include an understanding of biology, chemistry, medical or clinical practices. 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. 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: $27.83 - $33.72per 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 to the unique nature of their work. Summer hours are generally not available for field sales and m