Roswell Park Comprehensive Cancer Center · 16 hours ago
Research Technologist – Analytical Development and Quality Control (GMP)
Buffalo, NY
Full-time
Onsite
Entry, Mid Level
$50K/yr - $50K/yr
1+ years expRoswell Park Comprehensive Cancer Center is a nationally recognized cancer center focused on innovative patient-centered care. They are seeking a Research Technologist to support Analytical Development and Quality Control for cell therapy products in a dynamic cGMP environment, contributing to the advancement of cell and gene therapies.
Hospital & Health Care
Responsibilities
Execute analytical development and QC release testing of cell and gene therapy products under cGMP conditions, including endotoxin, sterility, qPCR, dPCR and potency assays
Draft, Review and maintain Standard Operating Procedure (SOPs), worksheets, forms, and QC release reports
Set up, calibrate and maintain QC instruments, perform Preventative Maintenance, and/or conduction of IQ/OQ/PQ
Ensure compliance with GMP/FDA guidelines and regulatory requirements for product release
Collaborate cross-functionally with Manufacturing Sciences, Process Development, Vector Development, and Quality Assurance teams to ensure seamless technology transfer, method suitability and qualification studies
Contribute to continuous improvement initiatives to optimize processes and ensure readiness for clinical trial demands and regulatory audits
Qualification
Required
Master's degree in a clinical or scientific discipline; or
Bachelor's degree in a clinical or scientific discipline and the equivalent of one (1) year of full-time experience in a laboratory setting
Extensive experience in Analytical Development or Quality Control settings
Demonstrated proficiency in cellular and molecular assays, such as flow cytometry, cytotoxicity, qPCR, dPCR, ELISA, and a strong analytical mindset and troubleshooting capabilities
Solid foundation in aseptic technique and mammalian cell culture, with a track record of maintaining sterility and culture integrity in high-throughput or regulated settings
Strong communication skills, with the ability to convey scientific concepts clearly across cross-functional teams; collaborative, articulate, and committed to scientific excellence
Exceptional attention to detail, especially in documentation, cleanliness, and organization critical qualities for maintaining reproducibility and regulatory compliance
Preferred
Working knowledge of cGMP standards, FDA/EU/ICH guidelines related to manufacturing of cell-based products is strongly preferred
Hands-on experience in cell therapy such as CAR-T, stem cell-based platforms, or other adaptive cell transfer modalities spanning research, process development, or manufacturing
Benefits
Full comprehensive benefits package
Company
Roswell Park Comprehensive Cancer Center
Welcome to Roswell Park Comprehensive Cancer Center, America's first cancer center founded in 1898 by Dr. Roswell Park.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
David Hohn
CEO Emeritus
Paul Visco
VP/ CTO - Chief Technology Officer
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