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 mon
Microbiology Supervisor, Quality Control
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Role overview
Job description
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 Bio is seeking a highly motivated and experienced QC Microbiology Supervisor to provide technical leadership and day-to-day oversight of microbiology and environmental monitoring activities supporting GMP ma
…What they are looking for
Skills & requirements
Qualification
The position will provide technical oversight of microbiology personnel, support investigations and contamination control activities, review and trend microbiological data, coordinate external laboratory testing, and contribute to the qualification and validation of microbiology methods, equipment, and processes; Oversee and perform microbiological media preparation, growth promotion testing, and media qualification in accordance with approved procedures and applicable compendial requirements; Ensure microbiology laboratory equipment is appropriately maintained, calibrated, qualified, and available for intended use; Support qualification and validation activities for microbiology equipment, processes, facilities, and analytical methods, including protocol development, execution, data review, and report generation
Department · Quality Control
Hiring company
Kincellis Advanced Therapies
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 about our capabilities and leadership team, please visit our website at www.kincellbio.com. To connect with the Talent Acquisition team, please email [email protected]. 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 a signed agreement. NOTE REGARDING EMPLOYMENT SCAMS: At Kincell, we take the security and well-being of our potential employees seriously. Please be aware of the following: Legitimate Communication: All official communication from Kincell regarding job opportunities will come from email addresses ending in @kincellbio.com (note two L's). Any communication from non-company email addresses or unofficial channels should be regarded as suspicious. Legitimate Job Openings: All open positions are posted on our company website's careers page and our official LinkedIn page. Job Application Process: Kincell will never ask for payment or personal information, such as your bank account or credit card details, as part of the recruitment process. Job Offers: Official job offers will always be made after a formal interview process including phone and Teams video interviews and onboarding documents sent via Kincell Bio's DocuSign account.
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