Operations Support Specialist

About the Role

The CAR-T Operations Support Specialist is part of the Technical Operations team, responsible for the production of a personalized cell therapy to support clinical and commercial requirements in a sterile cGMP environment. Job duties are performed within a team on an assigned production shift schedule.

Key Responsibilities

• Perform process unit operations (i.e., cell culture, purification, aseptic processing, and cryopreservation) according to standard operating procedures and batch records.
• Record production data and information in a clear, concise format.
• Perform tasks on time, consistent with safety policies, quality systems, and cGMP requirements.
• Build strong partnerships with Manufacturing, Engineering, and Quality.
• Work as part of a cross-functional team to complete production tasks required by the shift schedule.
• Support the development of manufacturing processes.
• Work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations.
• Routinely handle biological materials and hazardous chemicals.
• Interact with all levels within the organization.

Requirements & Tech Stack

• Bachelor’s degree in engineering or related field or equivalent experience.
• Minimum of 0-1 years of operations experience within a cGMP environment in the biotech/biopharma industry.
• Ability to build strong partnerships and integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Ability to work independently, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues, and balance competing priorities effectively.
• Clear and succinct verbal and written communication skills with an attention to detail.
• Ability to follow procedures.
• Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell-based products.
• Ability to lift a minimum of 50 lbs and stand for a long period of time.
• Sufficient vision and hearing capability to work in job environment.
• Physical dexterity sufficient to use computers and document production records.
• Ability to handle human derived materials in a BSL-2 cleanroom facility.
• Ability to accommodate shift work, including evenings and weekends, as required by the manufacturing process.
• Ability to accommodate unplanned overtime on little to no prior notice.