Associate Director, Bioanalytical Development

Formation Bio is seeking an Associate Director, Bioanalytical Development to lead bioanalytical strategy and delivery for assigned programs, working across nonclinical and clinical teams to ensure assays are fit for purpose and support key development decisions. The role will oversee external bioanalytical partners and drive execution for PK/TK, metabolites as applicable, biologics bioanalysis, and immunogenicity.

Requirements

• PhD in a relevant field with 7+ years of bioanalytical experience in biopharma, including clinical-stage support, or a relevant undergraduate degree with 10+ years of experience
• Lead bioanalytical strategy and execution for assigned preclinical and clinical programs across small molecules and biologics
• Deep LC–MS/MS expertise for PK/TK, troubleshooting, and ISR
• Familiar with biologics bioanalysis and immunogenicity (ADA/NAb) approaches and interpretation
• Strong working knowledge of bioanalytical regulatory expectations and submission-quality documentation
• Lead CRO/vendor execution for assigned workstreams; support partner selection and governance as needed
• Comfortable operating in a fast-paced, cross-functional environment with multiple concurrent priorities
• Clear communicator who can translate technical detail into program-relevant recommendations

Benefits

• Equity
• Comprehensive benefits
• Generous perks
• Hybrid flexibility