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Kincellis Advanced Therapies
Gainesville, FL
Source: Kincellis Advanced Therapies careers · View original posting
From Kincellis Advanced Therapies's posting. “We” and “our” refer to the employer.
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.
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 environmental monitoring (air, surface, compressed gas, and personnel) of the cleanrooms and laboratory to support GMP manufacturing to include off-hours/weekend coverage as needed.
Assist in maintaining microbiology and QC laboratories in a clean, orderly, compliant, and inspection-ready condition.
Execute laboratory experiments and assays (osmolality, pH, endotoxin, sterility, plate reading, etc.).
Perform data review and calculation verifications.
Participate in laboratory investigations including deviations and out of specifications.
Assist with laboratory equipment maintenance and calibration as needed.
Assist with environmental monitoring and assay related investigations.
Assist with qualification and validation of equipment, processes, and analytical methods, including protocol development and execution.Gai
Ensure all activities are performed in accordance with company policies, procedures, SOPs, GMP requirements, applicable regulatory expectations, and data integrity principles.
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
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