Senior Manufacturing Associate, 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.
• 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 (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 and Skills

• 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 therapy manufacturing or relevant experience.
• Bachelors in relevant science or engineering discipline and relevant experience is strongly preferred.

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.