Analyst III, Quality Control

Kincell Bio, LLC•Durham, NC

52d•Onsite

About The Position

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 QC Analyst III who will be a key contributor to a dynamic and collaborative Quality Control team. The Quality Control Analyst III will primarily be responsible for supporting and leading early/late phase and commercial quality control activities. This highly motivated member of the Quality Unit will support the organization through the execution of activities such as raw material testing, release testing, stability testing, and environmental monitoring. This Quality team member will be responsible for initiating and assisting in investigations and troubleshooting while adhering to cGMP and GDP practices.

Requirements

S. degree in science or a life science-related field of study
4+ years’ experience in Quality Control in a GMP environment
Proficiency in eukaryotic cell culture, molecular techniques, operation of microscopes, and equipment calibrations (e.g., pH meters and balances)
Strong technical laboratory skills (e.g., pipetting, weighing, and measuring pH)
Experience with writing standard operating procedures
An equivalent combination of education and experience may be considered.
Familiarity with FDA, ICH, and EU Regulations and Guidelines
Involvement in continuous improvement initiatives and laboratory investigations
Proficiency in Microsoft Office suite applications
Excellent attention to detail, organizational skills, and ability to multi-task in a dynamic environment.

Nice To Haves

4+ years’ experience in Quality Control in a GMP environment, preferably with experience in a microbiology laboratory
Experience with the following instrumentation: flow cytometers, qPCR, digital PCR, multimode plate readers

Responsibilities

Actively participate in fostering a positive, collaborative work culture.
Author and revise standard operating procedures, test methods, protocols, and reports.
Lead in execution of raw material testing, stability testing, environmental monitoring, critical utility monitoring, method qualifications, technical transfers, release testing, and method validations.
Assist in the transfer of assays from the Analytical Development Lab to the QC Lab.
Demonstrate proficiency in flow cytometric, automated cell counting, dPCR, qPCR, FTIR, ELISA-based, multiplex cytokine detection, pH, endotoxin, and cell-based assays.
Ensure QC deliverables are met in a timely manner.
Perform data analysis and review.
Initiate and participate in laboratory investigations including deviations and out of specifications.
Perform equipment calibrations.
Execute method and equipment troubleshooting and optimization, as needed.
Maintain documentation in accordance with GDP.
Train and cross train QC personnel on standard operating lab procedures and test methods.