Manufacturing Associate

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, following established standard operating procedures and company policies. You will conduct quality control analyses to support in-process batch production and detect any process deviations. This role involves handling leukapheresis-derived cellular materials; therefore, you will receive comprehensive training in hazardous material handling and emergency response procedures.

As part of the manufacturing operations, you will be expected to demonstrate a strong understanding of procedures, techniques, tools, materials, and equipment used in the production process. Your role will involve team-based decision-making, with a focus on prioritizing workflows based on process requirements and available resources. You will follow standard operating procedures to carry out tasks that may vary in scope, complexity, and duration.

Patients are counting on dedicated professionals like you—those who take pride in their work and strive for meaningful results. In this role, you'll play a vital part in ensuring life-changing therapies reach the patients who need them, exactly when they need them most!

Essential Duties and Responsibilities

Reasonable accommodations 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.

• Utilize proficiency in Microsoft Word, Excel, PowerPoint, and other relevant applications to support manufacturing operations.
• Apply knowledge of aseptic processing, cell culture, and cell therapy manufacturing within a cGMP-regulated environment.
• Maintain strict adherence to personal protective equipment (PPE) requirements to ensure a safe and compliant workspace.