Microbiology Technician III, Quality Control

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.

Assist with the qualification and validation of microbiology equipment, processes, facilities, and analytical methods, including protocol development, execution, data collection, and report generation.

Perform routine laboratory equipment maintenance, calibration activities, and troubleshooting as required.

Review laboratory data, worksheets, test records, and other controlled documentation for accuracy, completeness, and compliance with GMP and data integrity requirements.

Maintain the microbiology laboratory in a clean, organized, compliant, and inspection-ready condition.

Support laboratory readiness activities, including inventory management, preparation of laboratory supplies, and monitoring of media, reagents, and consumables.

Identify opportunities to improve microbiology laboratory processes, environmental monitoring practices, testing efficiency, and overall laboratory performance.

Train and provide technical guidance to less-experienced microbiology personnel on applicable laboratory procedures and microbiological techniques, as assigned.

Maintain proficiency in applicable microbiological methods and complete required training and competency assessments.

Comply with company policies, procedures, SOPs, GMP requirements, applicable regulatory expectations, and data integrity principles.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

Required

Bachelor’s degree in microbiology, biology, or another relevant scientific discipline with a minimum of 2 years of relevant microbiology laboratory experience, or a minimum of 5 years of relevant microbiology laboratory experience in lieu of a degree.

Demonstrated experience performing environmental monitoring in a classified cleanroom or controlled environment.

Hands-on experience with aseptic gowning and working within classified cleanroom environments.

Demonstrated experience performing microbiological testing in a GMP-regulated, pharmaceutical, biotechnology, cell therapy, or similarly regulated environment.

Experience with applicable microbiological methods, including environmental monitoring, bioburden, bacterial endotoxin, microbial enumeration, growth promotion, Gram staining, subculture techniques, microbial identification, and/or sterility testing.

Experience with microbiology investigations, environmental monitoring excursions, atypical results, or out-of-specification events preferred.

Experience with microbiological data analysis, trending, and technical report generation.

Experience supporting microbiology equipment, method, or process qualification and validation activities preferred.

Demonstrated ability to work independently, exercise sound judgment, and complete assigned activities with minimal direct supervision.

Strong organizational, analytical, and problem-solving skills with the ability to prioritize and manage multiple activities or projects simultaneously.

Ability to define problems, collect and evaluate data, establish facts, identify trends, and draw scientifically sound conclusions.

Strong attention to detail and commitment to accuracy, compliance, and data integrity.

Effective written and verbal communication skills, with the ability to communicate technical information clearly and professionally.

Demonstrated ability to adapt to a rapidly changing environment while maintaining quality, productivity, and compliance.

Proficiency with Microsoft Office applications and applicable laboratory information management systems.

Ability to work off-hours, weekends, or extended hours as required to support manufacturing and environmental monitoring activities.

Ability to wear required cleanroom and