Manufacturing Team Lead, liso cel CAR-T, Manufacturing Operations

Role Summary

Manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable. This position is for Quad 1, 5 am-5:30 pm, Sunday through Wednesday.

Start and end times are subject to change based on business demands.

• Oversee set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
• Lead deviation investigations and write ups as needed.
• Accountable for 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.
• Motivated, team consciousness individuals are needed to fulfill job requirements.
• Is a SME and qualified trainer within a designated function of manufacturing.
• Team Lead is responsible for the designated area within the shift.
• Shift supervision will be managed by the shift Supervisor, but Team Lead will act as Supervisor when needed.
• Maintain on time completion of training assignments and those of the associates in the designated area to ensure the necessary technical skills and process knowledge required to execute operations in a GMP compliant manner.
• Performs other tasks as assigned Lead continuous improvement projects, inspection readiness, right first-time initiatives, etc.

• 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
• Pre-requisites Senior Associate in Manufacturing

• Bachelor's degree and 2-4 years of experience in cell therapy or Biopharmaceutical operations.
• Associate / Medical Technical degree and 6+ years of Manufacturing

• Intermittent walking and sitting to perform job functions; ability to sit or stand for extended periods 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 around laboratories and controlled, enclosed, restricted areas.
• Cleanroom garments and PPE required in designated areas.
• Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
• Flexibility to don clean room garments and PPE.
• Clean room environment is enclosed, with assigned pressure and temperature conditions.
• Reagents, chemicals, and exposure to sanitization agents are expected.
• Routine exposure to human blood components. Exposure to strong magnets is likely.
• Designated areas may prohibit food and outside materials.
• Employees may be required to perform other job-related duties as requested by management.