Manager, Bioanalytical Regulatory
Core
Oversees bioanalytical functions at CROs to support method development, validation, and sample analysis for new chemical entities, metabolites, and biomarkers in preclinical and clinical studies.
Role type
Manager, Bioanalytical Regulatory (SME)
Builds
Regulated bioanalytical methods and data for PK/TK studies supporting INDs, BLAs, and regulatory submissions
Domain
Biopharmaceuticals / Bioanalysis / Drug Metabolism and Pharmacokinetics (DMPK)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Bioanalytical method development and validation, CRO management and oversight, LC-MS/MS and high-resolution mass spectrometry, PK/TK analysis, regulatory document preparation, team leadership and mentorship
Preferred skills
High-resolution mass spectrometry (ToF, Orbitrap, FT-ICR), low-flow electrospray mass spectrometry, peptide and protein bioanalysis, ligand-binding assays
Technologies
LC-MS/MS, high resolution mass spectrometry, low-flow (microflow) mass spectrometry, automation, enzyme- or immune-based assays
Responsibilities
Initiate and manage contracts with CROs for pharmacokinetics, toxicokinetics, and biomarker analysis; oversee CRO evaluation, SOP reviews, and site inspections; lead projects for in-vivo and ex-vivo study analysis; develop novel methodologies to characterize DMPK properties; mentor and supervise junior team members; prepare and review regulatory submissions and study protocols
Seniority
Manager, leads indirect teams and lower-level staff
