Manager, Bioanalytical Regulatory
Core
Oversees bioanalytical functions at CROs, managing method development, validation, and sample analysis for new chemical entities and biomarkers to support preclinical and clinical studies.
Role type
Manager, Bioanalytical Regulatory
Builds
Regulated bioanalytical methods and data for PK/TK studies
Domain
Biopharmaceuticals / Bioanalysis
Required skills
Bioanalytical method development and validation, CRO management and oversight, LC-MS/MS and automation expertise, Regulatory document preparation (INDs, BLAs), Team leadership and mentorship, Project management
Preferred skills
High resolution mass spectrometry (ToF, Orbitrap), Peptide and protein bioanalysis, Ligand-binding assays, GLP guidance knowledge
Technologies
LC-MS/MS, High resolution mass spectrometry, Automation, LC/UV
Responsibilities
Provide oversight of bioanalytical CROs for method transfer and validation; Initiate and manage contracts with CROs for PK/TK and biomarker analysis; Contribute to regulatory submissions and agency interactions; Conduct CRO evaluation, site visits, and technical monitoring; Lead projects for in-vivo and ex-vivo study analysis; Mentor and supervise junior team members
Seniority
Manager, leads indirect teams
