Senior Director, Bioanalytical LCMS

Added
6 minutes ago
Type
Full time
Salary
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Related skills

vendor management pharmaceutical biotechnology regulatory lc-ms/ms

πŸ“‹ Description

  • Lead LC-MS/MS bioanalytical strategy across discovery, preclinical, and clinical development
  • Serve as Amylyx's senior bioanalytical LCMS subject matter expert across cross-functional program
  • Oversee outsourced bioanalytical assay development and execution, including method development
  • Provide technical leadership across small molecule, peptide, and oligonucleotide bioanalysis
  • Lead external bioanalytical vendor strategy and oversight, including vendor selection, study
  • Partner with discovery, toxicology, clinical pharmacology, biostatistics, clinical development, and

🎯 Requirements

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

🎁 Benefits

  • Remote work opportunities within the United States (excluding Alaska and Hawaii)
  • Travel to corporate location in Cambridge, MA several times a year
  • Access to work setting enabling all role requirements (privacy, reliable internet, phone, video
  • Compensation: $260,000 - $292,000 USD (estimated pay range)
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