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, please visit our website at www.kincellbio.com.
Kincell is seeking a highly motivated Manufacturing Specialist who will be a key contributor to a dynamic and collaborative Manufacturing team.
As a Manufacturing Specialist, you will have the responsibility to assure initiatives related to production readiness and compliance are optimized and executed appropriately in the areas of cGMP production. This position will directly support manufacturing for all production-related activities. You will work with cross-functional teams to identify and implement meaningful corrective actions arising from deviations and audit observations. In addition, you will be operating automatic and manual cell therapy equipment with a variety of complexity in CAR-T, CAR-M, or CAR-NK processes in accordance with standard operating procedures and policies as needed. You will perform quality control analyses as required to complete in-process batches and identify variations. You will be trained in handling hazardous materials and emergency procedures since you will be handling leukapheresis cellular materials.
As part of manufacturing operations, you will be a team member who is relied on to have a good understanding of procedures, techniques, tools materials, and equipment to help support cGMP activities at the RTP, NC site. Your work and decision-making will be team-based and will focus on the prioritization of workflows centered on the process and available resources. You will follow standard operating procedures to complete tasks which may vary in scope, complexity, and timing.
Patients need colleagues like you who take pride in their work and look for successful outcomes. You will help ensure patients have the therapies they need when they need them. You will be operating cell therapy process equipment of varying complexity with different processes in accordance with standard operating procedures.
Essential Dutiesand 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.
Qualifications
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
Required:
Preferred:
Travel Requirements
Location
#LI-Onsite