Associate Director, Preclinical Bioanalytical Science

📋 Description

• Lead design and execution of bioanalytical and biomarker assays (LCMS, ELISA, qPCR).
• Manage external vendors; oversee scope, deliverables, timelines.
• Define assay selection criteria; ensure fit-for-purpose and timelines.
• Collaborate with toxicology, discovery biology, and clinical pharmacology.
• Review method development, validation, and sample analysis with partners.
• Support regulatory documents, abstracts, posters, and publications.

🎯 Requirements

• PhD in biology/chemistry or related; 4+ yrs bioanalytical exp in pharma/biotech/CRO.
• MS with 6+ yrs bioanalytical exp in pharma/biotech/CRO; biotech exp 2+ yrs; CRO exp a plus.
• Experience leading LCMS, ELISA, RT-qPCR, ADA, and biomarker assays (preclinical/IND).
• Knowledge of regulatory drug development (ICH M10) in a GxP environment.
• Strong interpersonal, communication, and cross-functional collaboration.
• Willingness to travel up to 20%.

🎁 Benefits

• Remote work opportunities within the United States.
• Travel to Cambridge, MA several times a year.
• Accommodations available for candidates requiring them.
• Amylyx is an Equal Opportunity Employer.