Director of Diagnostic Development

Main Responsibilities:

• Oversee diagnostic development, optimization, and testing
• Lead in-house analytical work and clinical validation
• Oversee CRO projects related to diagnostics
• Translate ELISA-like assays from a LDT (Lab Developed Test) to an FDA-approved Kit
• Contribute toward regulatory studies and clinical trials of diagnostic tests
• Independently design, execute, and interpret multiple studies. Design experiments to be carried out independently or as part of a collaborative team
• Be accountable for diagnostics project management, budgeting, timelines, and deliverables
• Primary point of contact with regulatory agencies during development process
• Provide assay support for therapeutic development projects
• Supervise and mentor team members
• Coordinate with partner organizations for manufacturing / tech transfer

Preferred Qualifications/Experience:

• Ph.D  in chemistry, biochemistry, pharmaceutical chemistry, bioengineering or related field
• Demonstrable experience in assay development and validation; experience in guiding an assay to FDA approval.
• Deep knowledge of peptide/protein chemistry, structures, and interactions. Strong in analytical, organic, and physical chemistry techniques.
• Good understanding of analytical and conformational protein characterization (including HPLC, MS, CD, functional assays)
• Experience with ELISAs, cell culture, handling human samples, chemical modifications, protein structural studies, planning animal experiments, analytical techniques, statistical analysis of results, pharmaceutical formulation, assay optimization Experience with quantitative diagnostics and biomarkers in a range of biological samples, including plasma and cerebrospinal fluid (CSF)
• Clinically validated assays used in clinical trials/designs