Jim Huleatt
Senior Director, Bioanalytical Sciences @ Ethyreal Bio
About
Immunologist with extensive R&D expertise supporting CMC, preclinical and clinical vaccine and monoclonal antibody development programs. Extensive knowledge of bioanalytical and serological method development, validation and GCLP regulatory compliance. Exceptional communication, leadership and presentation skills, ensuring cross-functional collaboration, team building, and guidance for both management and reports. Commitment to safety, quality and fostering productive teamwork and innovation.
United States
Greater Boston
Biotechnology
Technological Innovation, Project Management, Bioassay, Biomarkers, Analytical Methods Development, Method Development, Team Management, Serology, Bioanalysis, Scientific Analysis, Analytical Method Validation, Vaccines, Immunology, Protein Chemistry, Assay Development, In Vivo, In Vitro, ELISA, Molecular Biology, Lifesciences
Experience
Senior Director, Bioanalytical Sciences
Ethyreal Bio
Cambridge, MA
Senior Director leading PK/PD and Biomarker method development, validation & testing activities.
Senior Bioanalytical Consultant
Greater Boston
Independent consultant supporting bioanalytical testing and regulatory submissions.
Bioassay Development Lead
Gates Medical Research Institute
Cambridge, Massachusetts, United States
Principle Scientific Lead responsible for the development, qualification and validation of clinical bioanalytical methods and sample testing supporting the malaria monoclonal antibody (PK, ADA, NAb, ADCP) and vaccine (serology, RT-PCR) programs. Developed Clinical Testing Strategies and Coordinated GCLP testing activities at multiple CROs across the US, Europe, and Africa including method transfers, laboratory audits and release of clinical test results.
Director, Innovation & Technology Platform, Global Clinical Immunology
Sanofi
Swiftwater, Pennsylvania
Director, Innovation & Technology Platform, Global Clinical Immunology (’16-‘23) Deputy Director, Ligand Binding Serology, Global Clinical Immunology (’12-‘16) Deputy Director, Analytical Science and Assay Development (’07-‘12) Platform Leader responsible for leading the development, qualification and validation of new clinical serological methods (antibody binding, functional/cell-based and molecular assays) supporting Phase 1-3 viral and bacterial vaccine programs including: SARS-CoV-2, Influenza, RSV, CMV, Zika, Dengue, Tetanus, Diphtheria, Pertussis, N. Meningitis and S. pneumonia.
Education
The University of Connecticut Health Center
Biomedical Science- Immunology
Yale School of Medicine
Immunology
Bates College
Biology
Jim Huleatt's Contact Information
Phone
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