Manufacturing Associate, CAR-T Abecma CAR-T

Bristol Myers Squibb • Summit, NJ

7d • $28 - $34 • Onsite

About The Position

Manufactures 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.

Requirements

• Bachelor's Degree; OR Associate degree/Medical Technical Degree with at least 2 years of manufacturing or operations experience; OR High School Diploma/GED with at least 4 years of manufacturing or operations experience.
• Basic understanding of: Cell culture, Cryopreservation, Cell Expansion, Aseptic processing techniques, Laboratory techniques.
• Knowledge and understanding of cGMP and FDA-regulated manufacturing environments.
• Technical writing and documentation skills.
• Proficiency in Microsoft Office applications.
• Foundational knowledge of: Biology, Chemistry, Mathematics.
• Strong teamwork and communication skills.
• Ability to work effectively in a fast-paced manufacturing environment.
• Inventory control and/or management.
• Routine exposure to human blood components.
• Required to wear cleanroom garments and personal protective equipment (PPE), including coverings for: Head, Face (partial), Body, Legs and feet.
• Work in enclosed, restricted cleanroom areas with controlled pressure and temperature.
• Exposure to: Reagents, Manufacturing chemicals, Sanitization agents.
• Must comply with cleanroom restrictions, including prohibition of: Makeup, Gum, Nail polish, Personal electronic devices in designated areas.
• Ability to stand or sit for extended periods.
• Frequent walking and movement throughout the manufacturing area.
• Ability to use computers and complete documentation tasks.
• Ability to lift up to 25 pounds.
• Must possess sufficient vision and hearing to perform job duties safely.
• Must be flexible with production schedules, including weekend shifts and potential schedule changes based on business needs.

Responsibilities

• Manufacture human blood-derived cellular therapy products in accordance with SOPs and cGMP requirements.
• Perform cell culture maintenance and expansion, cell harvest, Isolation and cryopreservation activities.
• Execute aseptic processing activities, including: Tube welding, Sampling cell counts, Sterile connections, Material transfers.
• Weigh and measure in-process materials to ensure required quantities are added or removed.
• Adhere to production schedules and support on-time manufacturing operations.
• 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).
• Communicate production deviations and support quality investigations when required.
• Work collaboratively within a cross-functional, team-based manufacturing environment.
• Perform activities within a designated manufacturing function as assigned.
• Perform additional manufacturing-related tasks as directed by management.
• 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.
• Works in a team based, cross-functional environment to complete tasks required by shift schedule.
• Available to work OT when business requires.
• Willing to work staggered day shift hours.
• Records patient material handling data and information in a clear, concise, format according to proper GDPs.

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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED