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. The Senior Quality Assurance Associate supports the day-to-day early phase cell and gene therapy clinical GMP manufacturing operations via execution of all operational elements of the Quality Management System (QMS), including but not limited to the EDMS (electronic document management system) and training management system in support of gene and cell therapy manufacturing production. They will collaborate cross-functionally with Manufacturing, Supply Chain, Facilities, and the Laboratories to ensure cGMP compliance and establish a quality culture. This is a unique opportunity to help build and grow the Quality Assurance organization in a dynamic new environment. Experience with administrative access using Veeva as a document control and training management system preferred. 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. Essential Duties and Responsibilities Assist in executing QA responsibilities to support material and product release. Work with Quality team mem
Associate I, Manufacturing - Temporary Worker
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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. As a Contingent Manufacturing Associate I, you will be responsible for operating both automated and manual cell therapy equipment of varying complexity to support CAR-T, CAR-M, or CAR-NK manufacturing processes, fol
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Qualification
Required: High school diploma or equivalent required; 0–2 years of relevant education and/or experience in a related field; Preferred: Bachelor’s degree in Natural Sciences (e.g., Biology, Chemistry) or Engineering (e.g., Chemical, Biomedical) with 0–2 years of relevant manufacturing experience
Department · Manufacturing
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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