QC Analyst 1

Scope of 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 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.

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.

UHPLC-Based Methods (Purity and Residual Analysis)

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.

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 methods applicable to CGT drug substance/drug product testing.

Support compendial and non-compendial molecular testing.

Support method transfer, qualification and troubleshooting activities.

Generate and review technical protocols, reports and GMP-compliant documentation

Proteomic and/or Cell-based Methods

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

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 characterization techniques applicable to DNA, RNA, or plasmid characterization.

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

Working knowledge of proteomic or cell-based techniques used in CGT QC.

Familiarity with compendial methods is a plus.

Minimum Qualification

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.

Demonstrate working knowledge of cGMP requirements.

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

Strong verbal 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 must possess valid, unrestricted work authorization and be available to commence work immediately upon offer.