Director of Bioanalytical Sciences

Job Summary

To provide scientific and strategic leadership for bioanalysis supporting ocular therapeutic programs, the full-time remote Director of Bioanalytical Sciences will manage external partnerships, oversee bioanalytical strategies, and lead the potential establishment of an internal laboratory while ensuring compliance with regulatory standards.

Key responsibilities

• Define and own integrated bioanalytical strategies across various modalities, ensuring fit-for-purpose analytical plans
• Lead the selection and management of bioanalytical CROs, overseeing method development, validation, and sample analysis
• Build and mentor a team of scientists while managing departmental budgets and ensuring compliance with GLP and GCP standards

Required qualifications

• Ph.D. in analytical chemistry, biochemistry, pharmaceutical sciences, pharmacology, immunology, or a related discipline with 10+ years of industry experience; or M.S. with 14+; or B.S. with 16+
• Demonstrated bioanalytical leadership in pharmaceutical or biotechnology development for both small and large molecules
• Experience managing bioanalytical CROs and ensuring data quality and regulatory compliance
• Proven people leadership skills in hiring and developing scientific staff
• Deep knowledge of ICH M10, FDA immunogenicity guidance, and 21 CFR Part 11