Senior Manufacturing Associate, Cell Therapy - Devens MA

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS – Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps.

Unless specifically stated otherwise, this role is "On-site" at the location detailed in the job post.

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.

BMS Cell Therapy Manufacturing is seeking a Senior Manufacturing Associate, Cell Therapy that brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be goal-oriented, flexible, and able to work efficiently with safety and quality in mind. We are searching for enthusiastic, and innovative individuals with a good understanding of good manufacturing practices to support routine manufacturing operations for Cell Therapy.

• 6 AM – 6 PM, rotating shift including holidays and weekends, onsite
• 6 PM – 6 AM, rotating shift including holidays and weekends, onsite

• Execute operations described in standard operating procedures and batch records.
• Demonstrates strong practical and theoretical knowledge in their work.
• Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Solves simple problems; takes new perspectives using existing solutions.
• Performs tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
• Completing training assignments to ensure the necessary technical skills and knowledge.
• Training others on SOPs, Work Instructions to successfully complete manufacturing operations.
• Supports investigations.
• Identifies innovative solutions.
• Assisting in setting up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities.
• Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
• Training others on SOPs, Work Instructions to successfully complete manufacturing operations.
• Working with production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts.
• Work in a cleanroom environment and perform aseptic processing; maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Must have the ability to work assigned shift (Day, Night, Weekends and/or Holidays).
• Must be able to work in a cleanroom environment and perform aseptic processing.
• Must be comfortable being exposed to human blood components.
• Must be able to be in close proximity to strong magnets.
• Experience in cell therapy manufacturing, including Cell washing processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment.
• Experience in the following preferred:
  Aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas.
• Cell expansion using incubators and single use bioreactors.

• Basic Requirements:
  High school diploma and 3+ years of experience in cGMP bioprocessing manufacturing, cell…