Kincell Bio
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) that streamlines CMC development, applies expertise in analytical and process development, and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. Kincell Bio supports 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.
Title Analyst II, Quality Control
Essential Duties and Responsibilities
Actively participate in fostering a positive, collaborative work culture.
Author and revise standard operating procedures, test methods, protocols, and reports.
Execute raw material testing, stability testing, environmental monitoring, critical utility monitoring, method qualifications, technical transfers, release testing, and method validations.
Test material using 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.
Qualifications Required:
B.S. degree in a science or life science‑related field.
2+ years’ experience in Quality Control in a GMP environment.
Proficiency in eukaryotic cell culture, molecular techniques, microscope operation, and equipment calibrations (e.g., pH meters and balances).
Strong technical laboratory skills (pipetting, weighing, 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 flow cytometers, qPCR, digital PCR, and multimode plate readers.
Travel Requirements
None.
Location This position is 100% on‑site in Durham, NC, and will require some non‑standard working hours, including scheduled early mornings, late evenings, and/or weekends.
Equal Employment Opportunity Kincell Bio provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable, federalcsol, state, and local laws. We comply with applicable state and local non‑discrimination laws in every location where we have facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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For more information, please visit our website at www.kincellbio.com.
Title Analyst II, Quality Control
Essential Duties and Responsibilities
Actively participate in fostering a positive, collaborative work culture.
Author and revise standard operating procedures, test methods, protocols, and reports.
Execute raw material testing, stability testing, environmental monitoring, critical utility monitoring, method qualifications, technical transfers, release testing, and method validations.
Test material using 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.
Qualifications Required:
B.S. degree in a science or life science‑related field.
2+ years’ experience in Quality Control in a GMP environment.
Proficiency in eukaryotic cell culture, molecular techniques, microscope operation, and equipment calibrations (e.g., pH meters and balances).
Strong technical laboratory skills (pipetting, weighing, 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 flow cytometers, qPCR, digital PCR, and multimode plate readers.
Travel Requirements
None.
Location This position is 100% on‑site in Durham, NC, and will require some non‑standard working hours, including scheduled early mornings, late evenings, and/or weekends.
Equal Employment Opportunity Kincell Bio provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable, federalcsol, state, and local laws. We comply with applicable state and local non‑discrimination laws in every location where we have facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
#J-18808-Ljbffr