Formation Bio
Associate Director, Bioanalytical Development
$178K–$232K
Boston, MA +3 · Director · Full-time · Posted Mar 3, 2026
- Location
- Boston, MA
New York, NY
116 Huntington Ave., Back Bay, Boston, MA, 02116
16 E 34th St., New York City, NY, 10016 - Experience
- 7+ years with a PhD, including clinical-stage support; or 10+ years with a relevant undergraduate degree.
- Education
- PhD in a relevant field, or a relevant undergraduate degree.
About the job
Leads bioanalytical strategy and delivery for drug programs, overseeing external partners, assay execution, data quality, and submission-ready documentation across nonclinical and clinical development.
What you'll do
- Set assay and validation strategies; oversee bioanalytical execution, data review, and reports for program decisions and filings.
- Manage CROs and specialty labs, including scopes, timelines, quality, performance, and budgets.
- Coordinate with cross-functional teams on study design, sample logistics, regulatory submissions, and standardized workflows.
What they ask for
- PhD in a relevant field with 7+ years of biopharma bioanalytical experience, including clinical-stage support, or a relevant undergraduate degree with 10+ years of experience.
- Deep LC–MS/MS expertise for PK/TK, troubleshooting, and ISR.
- Familiarity with biologics bioanalysis and immunogenicity (ADA/NAb) approaches and interpretation.
- Strong working knowledge of bioanalytical regulatory expectations and submission-quality documentation.
Nice to have
- Experience on a clinical study team integrating vendor selection, development speed, assay quality, and method applicability.
- Familiarity with GCP/GCLP expectations, audit/inspection readiness, sample logistics, and data flow into filings.
Pay
$177,500 - $232,000 (USD; total compensation)
Tools
LC–MS/MS, PK/TK, ADA/NAb, GCP/GCLP
Model-written summary · the original posting is authoritative