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

About the role

The Manufacturing Associate is responsible for producing human blood-derived components in a controlled, cGMP cleanroom environment in accordance with Standard Operating Procedures (SOPs) and regulatory requirements. This role operates within a collaborative, shift-based team structure and plays a critical part in ensuring the quality, safety, and timely delivery of life-changing therapies.

Shift Schedule

Quad 1 — Sunday through Wednesday, 5:00 AM – 5:30 PM
Start and end times are subject to change based on business needs.

Key Responsibilities

• Set up and operate equipment to support blood component production through cell culture, harvest, and cryopreservation
• Apply aseptic technique for all applicable activities, including tube welding, connections, and transfers; aseptic qualification is required
• Weigh and measure in-process materials to ensure accurate quantities are added or removed
• Adequately adhere to the production schedule to support on-time, internal production logistics
• Record production data clearly and concisely in accordance with Good Documentation Practices (GDPs)
• Support deviation investigations and write-ups as needed
• Ensure on-time closure of assigned CAPAs within the designated shift
• Perform all tasks in alignment with site safety policies, quality systems, and GMP requirements

Team & Development

• Work in a team-based, cross-functional environment to fulfill shift production requirements
• Develop subject matter expertise (SME) and become a qualified trainer within a designated manufacturing function
• Maintain timely completion of all training assignments to uphold technical skills and process knowledge
• Contribute to continuous improvement projects, inspection readiness, and right-first-time initiatives, as assigned

Knowledge, Skills & Abilities

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or laboratory technique
• Familiarity with cGMP and FDA-regulated industry standards
• Strong technical writing capability
• Basic mathematical skills with a general understanding of cGMPs
• Proficiency in Microsoft Office applications

Education Requirements

• Education Level: Bachelor's Degree or Associate's / Medical Technical Degree
• Experience Required: 3+ years in Manufacturing Operations or equivalent combination of education and experience

Physical Requirements

• Intermittent walking and sitting
• Ability to stand or sit for extended periods
• Ability to lift up to 25 lbs
• Sufficient vision, hearing, and physical dexterity to perform job functions

Work-life Benefits

• Paid Time Off
• Flexible Time Off (unlimited, with manager approval, 11 paid national holidays)
• Summer Hours Flexibility
• Leaves of Absence for Medical, Personal, Parental, Caregiver, Bereavement, and Military Needs
• Global Shutdown between Christmas and New Years Day