QC Analyst 1
Job Location:
Watertown, NY - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 Assuranceto 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 analyticaltasksin a cross-functional collaborative environment supporting development and cGMP manufacturing of cell and gene therapies.
This role focuses on the development and optimization ofUHPLC-basedbiophysicalanalytical methods and/or PCR-based and related molecular methodssupporting CGTsafety identitypuritystrengthandqualitytesting includingresidual impurity andcompendialapplications such as Mycoplasma detection.
Scope of Responsibilities
Completerequiredread/understandcourses bench-work training andquality-controlled cGMPdocumentationrequirements.
Executeassignedanalytical test methodswithcGMPcompliance to support cell therapy manufacturing vector manufacturing and fill finish.
Support analytical assaydevelopmentensuring they are robust enough for qualificationtransition toquality controland successful implementation.
Perform general laboratory tasks including maintenanceand troubleshootingofequipment.
Maintain accurate and reliable recordselectroniclab 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 (-pairsizeexclusion 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 cytometryELISA/plate-reader-based assays as applicable to CGT QC.
Required Experiences
Hands-on operation of UHPLC instrumentation (e.g. Agilent Waters 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.
To Apply
Pleasesubmit your resume/CV along with a brief cover letter describing your relevant experience for oneor more applicable areas indicated above. Your cover letter should specifically address:
Your hands-on experience with relevant technique
Any additional relevant experience
Your familiarity with GMP and regulatory framework applicable to CGT analytical testing.
Landmark Bio is an Equal Opportunity Affirmative Action employer. Minorities women veterans and individuals with disabilities are encouraged to apply.
Required Experience:
IC
About Company
To Apply Please submit your resume/CV along with a brief cover letter describing your relevant experience for one or more applicable areas indicated above. Your cover letter should specifically address: Your hands-on experience with relevant technique Any additional relevant experienc ... View more
