QC Analyst I - CGT Analytics & Method Development

Artis BioSolutions; City of Watertown (NY); On-site; USD 55,000 - 75,000; Full time

Job summary

Landmark Bio in Watertown, NY is seeking a QC Analyst I to join a fast-paced cGMP environment, performing analytical testing for cell and gene therapy programs. You will execute UHPLC- and PCR-based assays, document results, and help ensure patient safety through compliant data and method execution.

Requires Bachelor’s in life sciences with 2+ years in biotech manufacturing; strong attention to detail, communication, and ability to prioritize.

Qualifications

• Hands-on operation of UHPLC instrumentation in a regulated or research setting.
• Working knowledge of molecular biology and/or biophysical techniques for DNA/RNA/plasmid characterization.
• Hands-on experience with PCR platforms and related molecular assays.

Responsibilities

• Complete required read/understand courses, bench-work training and quality-controlled cGMP documentation requirements.
• Execute assigned analytical test methods, with cGMP compliance, to support cell therapy manufacturing, vector manufacturing, and fill finish.
• Support analytical assay development ensuring they are robust enough for qualification, transition to quality control and successful implementation.
• Perform general laboratory tasks, including maintenance and troubleshooting of equipment.
• Maintain accurate and reliable records, electronic lab notebook entries, and all other pertinent documentation.
• Comply with all environmental health and safety standards.
• This is a hands-on lab-based position requiring flexibility based on cell & gene therapy drug product manufacturing schedule.
• Develop, optimize, and troubleshoot UHPLC-based methods (e.g., reverse phase, ion-pair, size exclusion) for purity analysis of small molecules, DNA, RNA, and related CGT residuals.

Skills

UHPLC systems

PCR platforms

Molecular biology

GMP compliance

Data recording

Communication

Education

Bachelor's in life sciences

Master's in biotech (optional)

Tools

Agilent instruments

Chromatography software

Job description

Landmark Bio in Watertown, NY is seeking a QC Analyst I to join a fast-paced cGMP environment, performing analytical testing for cell and gene therapy programs. You will execute UHPLC- and PCR-based assays, document results, and help ensure patient safety through compliant data and method execution.

Requires Bachelor’s in life sciences with 2+ years in biotech manufacturing; strong attention to detail, communication, and ability to prioritize.