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

Role Summary

Manufacturing Team Lead oversees manufacturing of human blood-derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Team members adhere to regulatory requirements while performing job functions. 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. Shift: Sunday - Wednesday (with every other Wednesday off); onsite night shift, 5:00 p.m. to 5:30 a.m.

Responsibilities

• 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-related 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 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-conscious 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.

Qualifications

• Bachelor’s degree and 4 years of experience in cell therapy in Biopharmaceutical operations.
• Or Associate / Medical Technical degree and 6+ years of Manufacturing Operations experience.
• Or High School diploma/GED and 8+ years of Manufacturing or Operations experience.
• Knowledge of cGMP/FDA regulated industry.
• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
• 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.

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.

Additional Requirements

• Physical demands: ability to lift up to 25 pounds; ability to stand or sit for extended periods; intermittent walking; good vision and hearing; manual dexterity to operate computers and documentation.
• Work environment: comfortable working with contained human blood components; must work around laboratories and controlled, enclosed areas; use of cleanroom garments and PPE in designated areas; adherence to cleanroom protocols (no makeup, gum, nail polish, or other potential microbial sources in restricted areas; ability to don cleanroom garments and PPE as required).
• Other: routine exposure to human blood components and possible exposure to strong magnets; designated areas may restrict outside materials such as cell phones or tablets.