Posted 2 days ago
QC Analyst 1
AI Summary
Performs laboratory testing and method development for cell and gene therapy products as a QC Analyst I, executing analytical methods and ensuring cGMP compliance.
About this role
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 within a fast-paced GMP environment. You will contribute to the development, qualification and execution of analytical methods supporting GMP release and characterization testing. Additionally, you will work cross-functionally with Analytical / Process Development, Manufacturing, and Quality Assurance to ensure methods meet regulatory and compendial expectations while supporting patient safety. This is an outstanding opportunity for a candidate to work under the guidance of a supervisor and mentor, manage time effectively, complete assigned analytical tasksin a cross-functional collaborative environment supporting development and cGMP manufacturing of cell and gene therapies.
This role focuses on the development and optimization of UHPLC-based biophysical analytical methods and/or PCR-based, and related molecular methods supporting CGT safety, identity, purity, strength and quality testing, includingresidual impurity and compendial applications such as Mycoplasma detection.
Scope of Responsibilities
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Complete required read/understand courses, bench-work training and quality-controlled cGMP documentation requirements.
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Execute assigned analytical test methods, with cGMP compliance, to support cell therapy manufacturing, vector manufacturing, and fill finish.
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Support analytical assay development ensuring they are robust enough for qualification, transition to quality control and successful implementation.
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Perform general laboratory tasks, including maintenance and troubleshooting of equipment.
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Maintain accurate and reliable records, electronic lab notebook entries, and all other pertinent documentation.
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Comply with all environmental health and safety standards.
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This is a hands-on lab-based position requiring flexibility based on cell & gene therapy drug product manufacturing schedule.
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UHPLC-Based Methods (Purity and Residual Analysis)
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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.
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Apply molecular biology and biophysical characterization techniques to support method development.
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Support technical transfer and method qualification activities.
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Generate and review technical protocols, reports and GMP documentation. Troubleshoot chromatographic performance issues (e.g., peak shouldering, tailing, resolution) and propose corrective strategies.
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PCR-Based Methods (qPCR / dPCR/ ddPCR)
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Develop and optimize PCR methods applicable to CGT drug substance/drug product testing.
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Support compendial and non-compendial molecular testing.
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Support method transfer, qualification and troubleshooting activities.
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Generate and review technical protocols, reports and GMP-compliant documentation
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Proteomic and/or Cell-based Methods
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Contribute to assay development activities using cell-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
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Hands-on operation of UHPLC instrumentation (e.g., Agilent, Water’s platform) in a regulated or research setting.
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Working knowledge of molecular biology and/or biophysical characterization techniques applicable to DNA, RNA, or plasmid characterization.
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Hands-on experience with PCR platforms and related molecular assays.
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Working knowledge of proteomic or cell-based techniques used in CGT QC.
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Familiarity with compendial methods is a plus.
Minimum Qualification
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QC Analyst I: 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.
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Demonstrate working knowledge of cGMP requirements.
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Ability to manage and prioritize tasks and projects, with the guidance of management.
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Strong verbal and written communication skills.
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Strong leadership skills, with an excitement to both roll up your sleeves and be a thoughtful partner.
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Detail-oriented with strong problem solving and troubleshooting skills.
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Applicants must possess valid, unrestricted work authorization and be available to commence work immediately upon offer.
