Kincell Bio · 2 days ago
Analyst I, Quality Control
Durham, NC
Full-time
Onsite
New Grad, Entry LevelKincell Bio is a contract development and manufacturing organization focused on streamlining CMC development for immune cell therapies. The Quality Control Analyst I will support late-phase and commercial quality control activities, including testing and documentation while adhering to cGMP and GDP practices.
BiopharmaBiotechnologyPharmaceutical
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
Qualification
Required
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
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
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
Preferred
Experience in Quality Control in a GMP environment, preferably with experience in a microbiology laboratory
Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience desirable
Company
Kincell Bio
Kincell Bio collaborates with cell therapy developers by using considerable scientific experience and industry understanding.
Founded in 2023
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$58MKey Investors
Kineticos Ventures
2025-05-15Series Unknown· $22M
2023-07-26Series A· $36M
Leadership Team
Lawrence Pitcher
Chief Executive Officer
Recent News
2026-01-06
Precedence Research
2025-11-27
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