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.
#J-18808-LjbffrAnalytical Scientist, CMC in durham at Unknown Company
This position is listed as full time and onsite.