Analyst I, Quality Control

Kincell Bio, LLC•Durham, NC

7h•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. Quality Control Analyst I will primarily be responsible for supporting 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. As part of the Quality operations, you will initiate and assist in investigations and troubleshooting while adhering to cGMP and GDP practices.

Requirements

B.S. degree in science or a life science-related field of study
Experience in Quality Control in a GMP environment, preferably with experience in a microbiology laboratory, is preferred.
Experience with the following instrumentation: Flow Cytometer (i.e., NC-200), Cell Counter (i.e., NC-200), Hematology Analyzer, Ella
Proficiency in cell culture of microbiological organisms, operation of microscopes, and equipment calibrations (e.g. pH meters and balances)
An equivalent combination of education and experience may be considered.
Strong technical laboratory skills (e.g. pipetting, weighing, and measuring pH)
Involvement in continuous improvement initiatives and laboratory investigations
Strong technical laboratory skills (e.g., pipetting, weighing, and measuring pH)
Proficiency in Microsoft Office suite applications.
Detail-oriented and highly motivated with excellent written and verbal communication skills required.
Ability to work independently and stay on task in a fast-paced environment without direct supervision.
Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.

Nice To Haves

Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience desirable.

Responsibilities

Actively participates in fostering a positive, collaborative work culture.
Authoring and revision of standard operating procedures, test methods, protocols, and reports
Participate in executing raw material testing, stability testing, environmental monitoring, critical utility monitoring, method qualifications, technical transfers, release testing, and method validations.
Testing of material utilizing methods such as pH, Osmolality, Appearance, cell culture, bacterial endotoxin, dPCR, ELISA, and other assays used for release and characterization of products.
Data analysis and review
Initiate and participate in laboratory investigations, including deviations and out-of-specifications.
Perform equipment calibrations and analysis of cell viability.
Participate in the execution of method and equipment troubleshooting and optimization.
Maintain documentation in accordance with GDP.
Other duties as assigned.