QC Analyst 1

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

The Quality Control -Analyticsdepartmentsupportsa growing portfolio ofcell and gene therapy(CGT)products, including CAR-T, iPSC, AAV, LVV and synthetic DNA products. Weareimmediatelyrecruiting for ahighly motivatedQC AnalystIto perform laboratory testingwith distinct technical but complementary focuswithin a fast-paced GMP environment.You willcontribute to the development, qualification and execution of analytical methods supporting GMP release and characterization testing.Additionally, you will work cross-functionally with Analytical/ ProcessDevelopment, Manufacturing, and Quality Assurance to ensure methods meet regulatory and compendial expectations while supporting patient safety.This is an outstanding opportunity for a candidate towork under the guidance of a supervisorand mentor, manage time effectively, complete assigned analyticaltasks in a cross-functional collaborative environment supporting development and cGMP manufacturing of cell and gene therapies.

Scope of Responsibilities

• Completerequiredread/understandcourses, bench-work training andquality-controlled cGMPdocumentationrequirements.

• Executeassignedanalytical test methods,withcGMPcompliance, to support cell therapy manufacturing, vector manufacturing, and fill finish.

• Support analytical assaydevelopmentensuring they are robust enough for qualification,transition toquality controland successful implementation.

• Perform general laboratory tasks, including maintenanceand troubleshootingofequipment.

• Maintain accurate and reliable records,electroniclab notebookentries, and all other pertinent documentation.

• Comply with allenvironmental health and safety standards.

• This is a hands-on lab-based position requiringflexibilitybased oncell & gene therapy drug product manufacturing schedule.

• UHPLC-BasedMethods(Purity and Residual Analysis)

• Develop, optimize, and troubleshoot UHPLC-based methods (e.g.,reversephase,ion-pair,sizeexclusion etc.) for purity analysis of small molecules, DNA, RNA, and related CGT residuals.

• Apply molecular biology and biophysical characterization techniques to support method development.

• Support technical transfer and method qualification activities.

• Generate and review technical protocols, reports and GMP documentation. Troubleshoot chromatographic performance issues (e.g., peak shouldering, tailing, resolution) and propose corrective strategies.

• PCR-Based Methods(qPCR/ dPCR/ ddPCR)

• Develop and optimize PCR methodsapplicable to CGT drug substance/drug product testing.

• Support compendial and non-compendial molecular testing.

• Support method transfer, qualification and troubleshooting activities.

• Generateand review technical protocols, reports and GMP-compliant documentation

• Proteomic and/or Cell-based Methods

• Contribute to assay development activities usingcell-based and/or proteomics-based approaches, e.g., cell culture-based cytotoxicity assays, flow cytometry,ELISA/plate-reader-based assays as applicable to CGT QC.

Required Experiences

• Hands-on operation of UHPLC instrumentation (e.g., Agilent, Water's platform) in a regulated or research setting.

• Working knowledge of molecular biology and/or biophysical characterizationtechniques applicable to DNA, RNA, or plasmid characterization.

• Hands-on experience with PCR platforms and related molecular assays.

• Working knowledge of proteomic or cell-basedtechniques used in CGT QC.

• Familiarity withcompendial methods is a plus.

MinimumQualification

• QC Analyst I:Bachelorswith minimum of 2 years or Masters with minimum of 1 year of relevant work experience, preferablyin a cGMP biotechnology manufacturing environment, ideally with hands-on experience in cell and/or gene therapy.

• Demonstrateworking knowledge of cGMP requirements.

• Ability to manage and prioritize tasks and projects, with the guidance of management.

• Strongverbal and written communication skills.

• Strong leadership skills, with an excitement to both roll up your sleeves and be a thoughtful partner.

• Detail-oriented with strong problem solving and troubleshooting skills.

• Applicants mustpossess valid, unrestricted work authorizationandbe available tocommence work immediatelyuponoffer.

Landmark Bio is an Equal Opportunity, Aff...? Minorities, women, veterans, and individuals with disabilities are encouraged to apply.