Analytical Scientist, CMC

Role: Hands-on Analytical Scientist in CMC for gene therapy programs at a clinical-stage biotech focused on retinal diseases. Responsibilities: develop, qualify, transfer, troubleshoot analytical methods (identity, purity, potency, safety, stability); perform cell-based potency assays and bioanalytical tests (qPCR/ddPCR, ELISA, HPLC/UPLC); review external data; author technical documents; support regulatory submissions; contribute to stability and characterization activities; collaborate across R&D, Quality, Regulatory. Requirements: B.S./M.S. in Biochemistry, Molecular Biology, Analytical Chemistry, or related; 4+ years in analytical development or QC in biotech/pharma; hands-on experience with AAV gene therapies and analytical techniques; managing CRO/CDMO activities; familiarity with GMP, ICH, FDA standards; strong technical writing. Preferred: ophthalmology/ocular gene therapy background, startup experience. WorkSetup: onsite Durham, NC; local candidates strongly preferred; salary $130K-$180K.