About The Position

Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers from early-stage CMC, process and analytical development through clinical supply, pivotal-stage programs and commercial supply. With facilities in Gainesville, Florida; Research Triangle Park, North Carolina; and The Woodlands, Texas, Kincellis combines broad technical expertise with flexible, scalable GMP infrastructure across autologous and allogeneic therapies, including but not limited to CAR-T, Tregs, CAR-NK, MSCs, dendritic cell vaccines, exosomes, iPSCs & synthetic mRNA. This role is a temporary contract position.

Requirements

  • High school diploma and a minimum of 2 years related experience.
  • Proficiency in Microsoft Office suite applications.
  • An equivalent combination of education and experience may be considered.
  • Strong organizational, communication, and analytical skills.
  • Able to prioritize and manage through multiple complex processes/projects.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Detail-oriented and highly motivated with excellent written and verbal communication skills.
  • Ability to work independently and stay on task in a fast-paced environment without direct supervision.
  • Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.
  • Able to wear cleanroom/protective gowning and equipment, including but not limited to full body gowning, goggles, face shields, and protective gloves for extended periods of time.

Nice To Haves

  • Bachelor’s degree in microbiology, biology, or another relevant scientific discipline.
  • Experience working within a cleanroom is a plus.

Responsibilities

  • Perform environmental monitoring (air, surface, compressed gas, and personnel) of the cleanrooms and laboratory to support GMP manufacturing to include off-hours/weekend coverage as needed.
  • Assist in maintaining microbiology and QC laboratories in a clean, orderly, compliant, and inspection-ready condition.
  • Execute laboratory experiments and assays (osmolality, pH, endotoxin, sterility, plate reading, etc.).
  • Perform data review and calculation verifications.
  • Participate in laboratory investigations including deviations and out of specifications.
  • Assist with laboratory equipment maintenance and calibration as needed.
  • Assist with environmental monitoring and assay related investigations.
  • Assist with qualification and validation of equipment, processes, and analytical methods, including protocol development and execution.
  • Ensure all activities are performed in accordance with company policies, procedures, SOPs, GMP requirements, applicable regulatory expectations, and data integrity principles.
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