Director, Bioanalytical LCMS

📋 Description

• Develop and execute LC-MS/MS bioanalytical strategies across discovery, preclinical, and clinical
• Serve as a bioanalytical LCMS subject matter expert on cross-functional program teams, providing
• Oversee outsourced bioanalytical assay development and execution, including method development
• Provide technical expertise across small molecule, peptide, and oligonucleotide bioanalysis
• Manage external bioanalytical vendors, including vendor selection, study planning, technical
• Partner with discovery, toxicology, clinical pharmacology, biostatistics, clinical development, and

🎯 Requirements

• Ph.D. in biology, chemistry, analytical chemistry, pharmaceutical sciences, or a related scientific
• Demonstrated experience developing and managing LC-MS/MS bioanalytical programs spanning
• Demonstrated technical expertise in bioanalytical method development, qualification, validation
• Strong knowledge of bioanalytical regulatory requirements and guidance, including ICH M10
• Experience overseeing outsourced bioanalytical work, including vendor management, technical issue
• Demonstrated experience contributing to regulatory documents and supporting health authority

🎁 Benefits

• Remote work opportunities within the United States
• Opportunity to travel to corporate location in Cambridge, MA several times a year