Contingent Worker, Microbiology Technician III

Kincell Bio, LLC•Gainesville, FL

2d•Onsite

About The Position

Kincell Bio engineers cells into therapies. With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCR, TILs, Tregs and CAR-NK technologies. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance. For more information, please visit our website at www.kincellbio.com. Kincell is seeking a highly motivated 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.

Requirements

Strong organizational and analytical skills.
Strong independent work ethic.
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.
Bachelor’s Degree in a scientific discipline with 2 years related experience OR a minimum of 5 years related experience.
Proficiency in Microsoft Office suite applications
An equivalent combination of education and experience may be considered.

Nice To Haves

Environmental monitoring experience in a cleanroom setting is required.

Responsibilities

Perform environmental monitoring (air, surface, compressed gas, and personnel) of the cleanrooms and laboratory to support GMP manufacturing to include off hours and weekends when required.
Manage and schedule contract testing laboratories for environmental monitoring and testing.
Perform critical utility monitoring.
Perform QC testing on raw materials and in-process products. Generate records in compliance with GMP requirements.
Coordinate QC testing with external labs including sample submission and final reports.
Proper media, buffer and reagent preparation.
Perform growth promotion of microbiological media.
Operate and maintain the lab in a neat and orderly way – following procedures and completing/ maintaining appropriate records.
Thorough and focused execution of laboratory experiments and assays (bioburden, endotoxin, gram stain, plate reading, etc.).
Perform laboratory equipment maintenance and calibration as needed.
Perform data analysis and trending, report generation, and conclusions.
Perform environmental monitoring and assay related investigations.
Assist with qualification and validation of equipment, processes, and analytical methods, including protocol development and execution.
Comply with all company policies, procedures, and SOPs.