Role Overview
The CAR-T Operations Support Specialist will be part of the Technical Operations team responsible for the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team based on an assigned production shift schedule.
Key Responsibilities
- Perform process unit operations (cell culture, purification, aseptic processing, cryopreservation) per SOPs and batch records; record production data clearly.
- Perform tasks on time in accordance with safety policies, quality systems, and cGMP requirements.
- Partner with Manufacturing, Engineering, and Quality to complete shift-scheduled production tasks.
- Support development of manufacturing processes; drive continuous improvements and efficiencies.
- Routine exposure to/handling of biological materials and hazardous chemicals.
- Interact with all levels within the organization.
Requirements
- Bachelorβs degree in engineering or related field (or equivalent experience).
- 0β1 years of operations experience in a cGMP biotech/biopharma environment.
- Ability to build partnerships and work effectively in a matrixed environment with external collaborators.
- Ability to work independently; prioritize and manage multiple tasks; integrate cross-functional issues.
- Clear verbal/written communication with attention to detail; follows procedures.
- Knowledge of cGMP regulations and FDA guidance for cell-based product manufacturing.
- Lift 50 lbs; stand for extended periods; sufficient vision/hearing and physical dexterity for computers and documentation.
- Ability to handle human-derived materials in a BSL-2 cleanroom.
- Accommodate shift work (evenings/weekends) and unplanned overtime with little notice.
Benefits (as stated)
- Medical, dental, vision; 401(k) with company match; 8 weeks paid parental leave after 3 months; paid time off (vacation, personal, sick, floating holidays) and 11 company holidays.