Analyst III, Quality Control

Kincell Bio is a technology-forward contract development and manufacturing organization (CDMO) that streamlines analytical development, process development, CMC consulting, and early-stage GMP cell therapy manufacturing. Our focus is on developing and manufacturing immune cell therapies, including autologous and allogeneic CAR-T, CAR-NK, and CAR-M programs. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance.

The Quality Control Analyst III will play a key role in supporting and leading early and late-phase release testing activities. This position requires a highly motivated individual who can execute analytical method qualification activities in compliance with ICH Q2(R2) guidelines and document all work in a clear, precise, and inspection-ready manner.

A significant focus of this role is technical writing—preparing thorough, well-organized reports for release testing, qualification studies, investigations, and troubleshooting activities. The ideal candidate will have hands-on experience performing assay qualification, generating technical documentation, and ensuring that all work meets cGMP and GDP standards for regulatory compliance.

This role requires collaboration with cross-functional teams to support audits, inspections, and regulatory submissions, while maintaining high standards of data integrity and scientific rigor.

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.

Essential Duties and Responsibilities

Actively contributes to a positive, collaborative, and high-performance work culture.

• Author, revise, and maintain standard operating procedures, test methods, qualification protocols, and technical reports in a clear, thorough, and inspection-ready manner.
• Perform release testing and method qualification activities in compliance with ICH Q2(R2) guidelines, ensuring assays are executed accurately and efficiently.
• Conduct testing using methods such as pH, osmolality, appearance, cell culture, dPCR, ELISA, and other assays relevant for release and characterization of products.
• Ensure QC deliverables are completed on schedule and meet quality standards.
• Analyze and review data, interpreting results and documenting findings in a scientifically sound manner.
• Participate in laboratory investigations, including deviations and out-of-specification events, providing detailed reports as needed.
• Execute method and equipment troubleshooting and optimization, supporting assay performance and reliability.
• Perform equipment calibration and maintenance as required to ensure accurate and consistent testing.
• Maintain all documentation in accordance with cGMP and GDP standards, ensuring completeness and regulatory compliance

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. 

Required:

• B.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)
• An equivalent combination of education and experience may be considered.
• Strong technical laboratory skills (e.g., pipetting, weighing, and measuring pH)
• Experience with writing standard operating procedures
• Familiarity with FDA, ICH, and EU Regulations and Guidelines
• Involvement in continuous improvement initiatives and laboratory investigations
• Proficiency in Microsoft Office suite applications

Preferred:

• 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

Travel Requirements

• None

Location

• This is a site-based position located in Gainesville, FL and will require some non-standard working hours, including scheduled early mornings, late evenings, and/or weekends.

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