WHO YOU ARE

We are seeking an experienced Principal Scientist/Associate Director in Bioanalytical Sciences to lead bioanalytical strategy and execution for our AAV-based gene therapy asset for the treatment of classic galactosemia. This individual will play a key leadership role in overseeing bioanalytical and biomarker method development, qualification, and validation through effective CRO management and cross-functional collaboration. The ideal candidate brings deep expertise in bioanalytical sciences for gene therapy, strong vendor management skills, and experience contributing to regulatory filings.
Requirements:

EDUCATION, EXPERIENCE & SKILLS REQUIREMENTS

• Ph.D. in Molecular Biology, Biochemistry, Pharmacology, or related discipline with 8+ years of industry experience in bioanalytical sciences; or M.S. with 10+ years.
• Demonstrated expertise in nucleic acid and protein bioanalytical methods (qPCR/ddPCR, ELISA, ECLIA, immunoassays, LC-MS/MS, etc.).
• Extensive experience managing CROs, including method development, qualification/validation, and sample analysis.
• Strong knowledge of GLP/GCP and regulatory expectations for bioanalytical assays supporting gene therapy programs (FDA/EMA/ICH).
• Experience authoring bioanalytical strategy in regulatory submissions.
• Excellent leadership, communication, and vendor management skills; ability to drive execution through external partners.
• Previous experience with AAV or other gene therapy platforms strongly preferred.

• Lead the design and execution of bioanalytical strategies for AAV gene therapy programs, spanning preclinical through clinical development.
• Oversee and manage CROs/contract labs performing bioanalytical assays (qPCR/ddPCR, ELISA, ECL, LC-MS/MS, NGS, etc.) for biodistribution, pharmacokinetics, pharmacodynamics, immunogenicity, and biomarker assessments.
• Provide scientific and technical oversight of assay development, validation, and sample analysis at CROs to ensure regulatory compliance (GLP/GCP).
• Serve as the primary point of contact between internal teams and CRO partners to ensure quality, timelines, and deliverables.
• Partner with preclinical, clinical, and regulatory colleagues to integrate bioanalytical data into study design, data interpretation, and regulatory submissions (e.g., IND, CTA, BLA).
• Author/review bioanalytical sections of protocols, validation reports, study reports, and regulatory filings.
• Monitor emerging regulatory guidance in gene therapy bioanalytics and ensure alignment of internal and CRO practices.
• Travel: up to 20% of time