PURPOSE AND SCOPE OF POSITION: 

BMS Cell Therapy Manufacturing seeks Lead 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.  

SHIFT: 6:00 PM - 6:00 AM

REQUIRED COMPETENCIES:

Education: 

• 4+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience 
• Bachelors in relevant science or engineering discipline, or equivalent in work experience.  

Basic Qualifications:

• 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.  

Preferred Qualifications:  

• 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.  
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DUTIES AND RESPONSIBILITIES: 

• Execute operations described in standard operating procedures and batch records.  
• Demonstrates strong practical and theoretical knowledge in their work 
• Completes documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.  
• Solves complex 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.  
• Sets up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities.  
• Collaborates with support groups on recommendations and solving technical problems. 
• Help to ensure the shift works effectively in a team based, cross-functional environment to complete all production tasks required by shift schedule.  
• Collaborates closely with Shift Managers to ensure seamless pass down and communication of operational status.  
• Supports investigations   
• Identifies innovative solutions  
• Supports 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 with leadership 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.  

PHYSICAL DEMANDS:  

• Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time, throughout the day.  
• Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials.  
• Climb - Required to climb (use of stepladders in production areas, or stairwells) several times a day.  
• Bend and Kneel - Required to bend or kneel several times a day.  
• Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day, throughout the day.  
• Moving Head and Neck – Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day, throughout the day.  
• Twisting - Required movement of twisting waist while setting up equipment several times a day, throughout the day.  
• Repetitive Use - Required repetitive use of arms/wrists/hands while setting up equipment and processing several times a day, throughout the day.  
• Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection. 

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