Specialist, Lead Clinical Manufacturing Associate, Cell Therapy

About the role

Bristol Myers Squibb is seeking a Specialist, Lead Clinical Manufacturing Associate, Cell Therapy to join our dynamic team. This role offers unique opportunities to contribute to groundbreaking cell therapy programs.

Responsibilities

• Perform clinical patient process unit operations and support operations as outlined in standard operating procedures and batch records.
• Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Ensure compliance with safety policies, quality systems, and cGMP requirements.
• Complete training assignments to ensure necessary technical skills and knowledge.
• Work in a cleanroom environment and maintain manufacturing environmental conditions according to global Health Authority requirements.
• Solve complex problems and identify innovative solutions.
• Set up manufacturing areas and equipment/fixtures.
• Participate in facility and equipment commissioning activities.
• Collaborate with production planning to execute daily unit operations schedules.
• Support development of manufacturing operating procedures.
• Support quality event investigations.

Requirements

• 4+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.
• Bachelor's degree in relevant science or engineering discipline, or equivalent work experience.
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Ability to work assigned shift (Day, Night, Weekends, and/or Holidays).
• Comfortable working in a cleanroom environment and performing aseptic processing.
• Experience in cell therapy manufacturing, including cell washing processes, cell separation processes, cryopreservation processes, cell expansion processes using incubators and bioreactors, and automated equipment.
• Experience with aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas.

Qualifications

• Driven and motivated individual to learn and execute Cell Therapy Manufacturing operations.
• Ability to work in a cleanroom environment and perform aseptic processing.
• Comfortable working with human blood components.
• Ability to be in close proximity to strong magnets.
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.
• Ability to travel to train and develop at other BMS Sites.

Skills & Abilities

• Strong practical and theoretical knowledge of work.
• Good understanding of good manufacturing practices.
• Problem-solving skills.
• Innovative thinking.

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.