Associate Director/Director, Bioanalytical Development
Location: Greater Boston
Salary: 170,000$ - 230,000$ Base
Discipline: Research & Development
- Responsible for reports and regulatory documents to submit to the FDA.
- Experience with Biologics (ADCs, mAbs) AND small molecules.
- Extensive knowledge of LC-MS/MS AND LBA based PK bioanalysis.
- Management of CDMOs/CROs method development, validation and sample analysis.
- D with 8+ years, M.S. with 12+ years, B.S. with 15+ years.
- Extensive experience with biologics AND small molecules.
- Management of CDMOs/CROs in LC-MS/MS and LBA.
- Experience with IND and NDA/BLA regulatory filings.