Clinical Manufacturing Associate II, Cell Therapy

Responsibilities

• Performing Clinical patient process unit operations and supporting operations described in standard operating procedures and batch records.
• Demonstrates strong practical and theoretical knowledge of work
• Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Solving simple problems; taking new perspectives using existing solutions
• Identifies innovative solutions
• Performing tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
• Completing training assignments to ensure the necessary technical skills and knowledge.
• Referencing Batch Records, Standard Operating Procedures and Work Instructions to successfully complete manufacturing operations.
• Executing daily unit operations schedule that includes people, product, and material flow across multiple shifts.
• Working in a cleanroom environment and performing aseptic processing; maintaining 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.
• Collaborating with support groups on recommendations and solving technical and operational problems.
• Assisting in setting up manufacturing areas and equipment/fixtures.
• Perform facility and equipment commissioning activities.
• Any related tasks as required to contribute to a new startup facility.

Working Conditions

• 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.

Knowledge and Skills

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.
• Driven and motivated individual to learn and execute Cell Therapy Manufacturing operations.
• 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 working with human blood components.
• Must be able to be in close proximity to strong magnets.
• Must be able to travel to train and develop at other BMS Sites. Travel durations typically a week or less.

Education and Experience

• High school diploma and 2+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience
• Bachelors in relevant science or engineering discipline is preferred
• GMP Compliance experience, knowledge of Data Integrity and ALCOA+ principles, and direct application of them.
• 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 is preferred.