Contingent Worker, Microbiology Technician III Gainesville, FL

Overview

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.

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 clean rooms, 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.

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

• Perform environmental monitoring (air, surface, compressed gas, and personnel) of the clean rooms 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.

Required:

• 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.

Preferred:

• Environmental monitoring experience in a cleanroom setting is required.

• None

• This is a laboratory-based position located at the Gainesville, FL site.

Kincell Bio provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable, federal, state, and local laws. Kincell Bio complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.

This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

NOTE TO EMPLOYMENT AGENCIES
:
Kincell Bio values our relationships with our Recruitment Partners. We will only accept resumes from those partners who have been contracted by a member of our Human Resources team to collaborate with us. We are not responsible for any fees related to resumes that are unsolicited or are received without contract.