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.

For more information, visit our website at www.kincellis.com.

Kincell is seeking a highly motivated QC Microbiology Technician III who will be a key contributor to a dynamic and collaborative Quality Control team.

This position will support the day-to-day activities of the manufacturing and quality control group by performing lot related and routine environmental monitoring of the cleanrooms, microbial assay testing, maintenance of laboratory supplies, routine data trending, and coordination of samples to outside testing laboratories. Personnel will work in concert with and assist the manufacturing department and play a critical role in ensuring environmental control of the aseptic manufacturing facility.

Essential Duties and Responsibilities

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.

Perform routine and non-routine environmental monitoring of classified cleanrooms and laboratory areas, including viable air, surface, personnel, compressed gas, and other applicable monitoring, in support of GMP manufacturing operations.
Perform environmental monitoring activities during off-hours, weekends, and other non-standard schedules as required to support manufacturing operations.
Serve as a senior technical resource for microbiology and environmental monitoring activities and provide guidance and support to other microbiology personnel as needed.
Perform critical utility microbiological monitoring in accordance with approved procedures, specifications, and established schedules.
Perform microbiological QC testing of raw materials, in-process materials, and other applicable samples in accordance with approved procedures and GMP requirements.
Perform microbiological assays including bioburden, bacterial endotoxin, microbial enumeration, Gram staining, microbial identification, subculture techniques, plate reading, and other applicable microbiological methods.
Perform sterility testing, method verification, method suitability, and other microbiological testing activities as qualified, including use of automated microbial detection systems such as the BacT/ALERT 3D System.
Prepare microbiological media, buffers, reagents, and other laboratory materials in accordance with approved procedures.
Perform growth promotion testing and qualification of microbiological media in accordance with approved procedures and applicable compendial requirements.
Coordinate microbiological testing with external contract laboratories, including sample submission, test requirements, scheduling, result review, and reconciliation of final reports.
Manage and coordinate contract laboratory testing for environmental monitoring and other microbiological analyses, as assigned.
Perform routine data review, analysis, and trending of microbiological and environmental monitoring data and contribute to technical reports and scientifically sound conclusions.
Initiate and/or support environmental monitoring and microbiological assay investigations, including assessment of atypical results, alert/action level excursions, out-of-specification results, and other microbiological events.
Assist with root cause investigations, impact assessments, corrective actions, and effectiveness evaluations associated with microbiological events.