Senior Clinical Manufacturing Associate, Cell Therapy

About the position

BMS Clinical Cell Therapy Manufacturing seeks Senior Clinical Associates within Manufacturing that bring 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.

Responsibilities

• 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 and 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.
• 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.

Requirements

• High school diploma and 3+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience.
• Bachelors in relevant science or engineering discipline and relevant experience is strongly preferred.
• 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.

Nice-to-haves

• Experience in cell therapy manufacturing, including Cell washing processes and automated equipment.
• Cell separation techniques and automated equipment.
• Cryopreservation processes and equipment.
• Experience in 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.

Benefits

• Competitive benefits, services and programs that provide resources to pursue goals at work and in personal lives.