Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations

Shift Available: Quad 3 Wednesday - Saturday (with every other Wednesday off), Onsite Day Shift, 5 a.m. - 5:30 p.m.

Responsibilities

• Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
• Support deviation investigations and write ups as needed.
• Support on time closure of any assigned CAPAs within the designated shift.
• Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum. Aseptic qualification is required.
• Weighs and measures in-process materials to ensure proper quantities are added/removed.
• Adheres to the production schedule ensuring on-time, internal production logistics.
• Records production data and information in a clear, concise, format according to proper GDPs.
• Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.
• Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
• Become a SME and qualified trainer within a designated function of manufacturing.
• Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge.
• Performs other tasks as assigned: continuous improvement projects, inspection readiness, right first-time initiatives, etc.

Knowledge & Skills

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills.
• General understanding of cGMPs.
• Technical writing capability.
• Proficient in MS Office applications.
• Background to include an understanding of biology, chemistry, medical or clinical practices.

Minimum Requirements

• High School Diploma required.
• Bachelor's or associate degree preferred.
• 0-1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience.

Working Conditions

• Intermittent walking, standing and sitting to perform job functions; however, ability to stand for extended periods of time may be necessary.
• Must be comfortable working with contained human blood components.
• Physical dexterity sufficient to use computers and documentation.
• Sufficient vision and hearing capability to work in job environment.
• Ability to lift 25 pounds.
• Must have the ability to work in laboratories and controlled, enclosed, restricted areas.
• Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
• Makeup, gum, nail polish, perfume/cologne and other potential microbial sources are prohibited in restricted areas.
• Flexibility to don clean room garments and personal protective equipment (PPE).
• Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions.
• Reagents, chemicals, and exposure to sanitization agents are expected.
• Routine exposure to human blood components.
• Restricted areas prohibit food, any outside materials such as cell phones, tablets, at a minimum.