Kincell Bio · 8 hours ago
Analyst II, Quality Control
Gainesville, FL
Full-time
Onsite
Entry, Mid Level
2+ years expKincell Bio is a contract development and manufacturing organization focused on engineering cells into therapies. They are seeking a highly motivated Analyst II, Quality Control, who will support and lead quality control activities, including testing and documentation in compliance with cGMP and GDP practices.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Actively participate in fostering a positive, collaborative work culture
Author and revise standard operating procedures, test methods, protocols, and reports
Perform execution of 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 FTIR, qPCR, SDS-PAGE, ELISA, pH, and bacterial endotoxin
Ensure QC deliverables are met in a timely manner
Perform data analysis and review
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
Qualification
Required
B.S. degree in science or a life science-related field of study
2+ 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
Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience desirable
Involvement in continuous improvement initiatives and laboratory investigations
Proficiency in Microsoft Office suite applications
Preferred
2+ 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
Benefits
Competitive benefits
Company
Kincell Bio
Kincell Bio collaborates with cell therapy developers by using considerable scientific experience and industry understanding.
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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