Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations

Manufacturing Associate, Cell Therapy team manufactures human blood-derived components per Batch Record and Standard Operating Procedures in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management.

• Wednesday - Saturday (every other Wednesday off), Onsite Night Shift, 5 p.m.
  
  - 5:30 a.m.
• Start and end times are subject to change based on business demands.

• 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.
• Apply aseptic technique for welding, connections, and transfers; aseptic qualification required.
• Weigh and measure in-process materials to ensure proper quantities are added/removed.
• Adhere to the production schedule ensuring on-time internal production logistics.
• Record production data 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.
• Work in a team-based, cross-functional environment to complete production tasks required by shift schedule.
• Be a motivated, team-conscious individual to fulfill job requirements.
• Become a subject-matter expert and qualified trainer within a designated manufacturing function; supervision managed by shift supervisor or designated team lead.
• Maintain on-time completion of training assignments to maintain necessary technical skills and process knowledge.
• Perform additional tasks as assigned, including continuous improvement projects, inspection readiness, right-first-time initiatives, and others.

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills.
• General understanding of cGMPs.
• Technical writing capability.
• Proficiency in MS Office applications.
• Background in biology, chemistry, medical or clinical practices.

• High School Diploma required;
  Bachelor’s or associate degree preferred.
• 0-1 year of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience.

• Intermittent walking, standing, and sitting; ability to stand for extended periods may be required.
• Comfortable working with contained human blood components.
• Physical dexterity sufficient to use computers and documentation.
• Sufficient vision and hearing capability to work in the job environment.
• Ability to lift 25 pounds.
• Work in laboratories and controlled, enclosed, restricted areas.
• Wear cleanroom garments and personal protective equipment covering head, face, core body, and legs/feet.
• Prohibited items: makeup, gum, nail polish, perfume/cologne, and other potential microbial sources in restricted areas.
• Flexibility to don cleanroom garments and personal protective equipment (PPE).
• Exposure to reagents, chemicals, and sanitization agents expected.
• Routine exposure to human blood components.
• Restricted areas prohibit food and outside materials such as cell phones, tablets, etc.

Summit West - NJ - US: $27.83 - $33.72 per hour; additional incentive cash and stock opportunities may be available. Final compensation will be determined based on experience.

• Health coverage: medical, pharmacy, dental, and vision care.
• Retirement plans: 401(k) matching.
• Paid time off and flexible leave options.
• Well-being support programs.

BMS is dedicated to ensuring that people with disabilities can excel through transparent recruitment process, reasonable workplace accommodations, and ongoing support in their roles. For more information, visit the BMS EEO accessibility page.