Landmark Bio
QC Analyst 1
Watertown, MA
Sponsorship not specifiedDetected 6 days ago
Computer VisionGMPPCRqPCRCRISPRFlow CytometryMolecular BiologyCell CultureResearchProtein AnalysisLeadershipCommunicationProblem Solving
About the role
- You will contribute to the development, qualification and execution of analytical methods supporting GMP release and characterization testing.
- Additionally, y ou will work cross-functionally with Analytical / Process Development, Manufacturing, and Quality Assurance to ensure methods meet regulatory and compendial expectations while supporting patient safety.
- 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.
Responsibilities
- The Quality Control - Analytics department supports a growing portfolio of cell and gene therapy (CGT) products, including CAR-T, iPSC, AAV, LVV and synthetic DNA products.
- We are immediately recruiting for a highly motivated QC Analyst I to perform laboratory testing with distinct technical but complementary focus with in a fast-paced GMP environment.
- Execute assigned analytical test methods, with cGMP compliance, to support cell therapy manufacturing, vector manufacturing, and fill finish.
- Support a nalytical assay development ensuring they are robust enough for qualification, transition to quality control and successful implem e ntation.
- Perform general laboratory tasks, including maintenance and t roubleshooting of equipment.
- Maintain accurate and reliable records, electronic lab notebook entries, and all other pertinent documentation.
- Develop, optimize, and troubleshoot UHPLC-based methods (e.g., reverse phase, ion-pair, size exclusion 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.
- Develop and optimize PCR methods applicable to CGT drug substance/drug product testing.
Requirements
- Your hands-on experience with relevant technique
- Complete required read/understand courses, bench-work training and quality-controlled cGMP documentation requirements.
- Required Experiences
Nice to have
- Bachelors with minimum of 2 years or Masters with minimum of 1 year of relevant work experience, preferably in a cGMP biotechnology manufacturing environment, ideally with hands-on experience in cell and/or gene therapy.
- Demonstrate working knowledge of cGMP requirements.
- Strong verbal and written communication skills.
- Detail-oriented with strong problem solving and troubleshooting skills.
- Applicants must possess valid, unrestricted work authorization and be available to commence work immediately upon offer.
- Please submit your resume/CV along with a brief cover letter describing your relevant experience for one or more applicable areas indicated above.
Benefits
- Comply with all environmental health and safety standards.
Visa & Work Authorization
- Applicants must possess valid, unrestricted work authorization and be available to commence work immediately upon offer.
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