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 Sr. Project Manager who will be a key contributor to a dynamic and collaborative Project & Program Management team. The senior project manager role is charged with delivering consistent project and program management on behalf of our customers, acting as their internal advocate within Kincell Bio, representing the voice of the customer, and ensuring effective cross-functional project and resource management. The senior project manager will have a strong background in biologic drug substance and/or drug product development, enabling them to credibly work with customers and department heads to drive programs through the critical path of process development and GMP manufacturing. The senior project manager will devise, integrate, and execute high-quality, cross-functional project plans that reflect the specific goals of each customer program. In collaboration with our customers, internal functional leaders, and scientific subject matter experts, the senior project manager will integrate scientific and business priorities to drive effective delivery of the program deliverables. The Client's senior project manager will be responsible for establishing effective teamwork, executing the program strategy, providing project leadership, and fa
Senior Associate, Quality Assurance - Temporary Contract
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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. 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)
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Physical Demands Adjusting or moving objects weighing up to 25lbs Must be able to become gown-qualified with participation within an ISO 7 cleanroom environment Travel Requirements N/A Location This is a site-based temporary position located in Gainesville, FL, and will require some non-standard working hours, including early morning or late evening
Department · Quality Assurance
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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