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Forge Biologics is seeking a Scientist I, Quality Control (Analytical) to join their team at The Hearth, a 200,000-square-foot cGMP manufacturing facility in Columbus, Ohio. The company focuses on enabling access to life-changing gene therapies, partnering with scientists, physicians, biotech and pharma innovators, and patient communities.
In this role, you will be responsible for executing analytical methods, method qualification, method validation, and troubleshooting efforts for AAV vectors, plasmids, and microbial and mammalian cell banks. You will perform in-process, final product, and stability testing while ensuring cGMP compliance and operational efficiency.
You will function as a subject matter expert (SME) for one of three analytical domains: nucleic acid-based methods (ddPCR, qPCR), protein-based assays (CE, AUC), or cell-based assays (TCID50, potency). The role includes fostering innovation within the QC department, either independently or in partnership with Analytical Development, to ensure cutting-edge technologies are employed in the analysis of gene therapy products.
Key responsibilities include performing in-process, release, and stability testing for assays relevant to viral vector and gene therapy products; executing assay qualification and validations; troubleshooting analytical methods; maintaining detailed documentation and records in compliance with cGMP regulations; collaborating with cross-functional teams including manufacturing, analytical development, and regulatory affairs; and contributing to continuous improvement initiatives within the QC department.
This position offers significant impact on the success of client gene therapy programs and provides opportunities for professional growth through mentorship and hands-on learning in a purpose-driven organization committed to improving patient outcomes.
