Study Director (Immunochemistry)
Core
Lead the technical conduct, analytical direction, and validation of ligand binding assays (LBA) for pharmacokinetic (PK) and anti-drug antibody (ADA) bioanalysis in preclinical and clinical drug development.
Role type
Senior Study Director / Principal Investigator (Immunochemistry)
Builds
Validated bioanalytical methods and study reports for pharmaceutical clients
Domain
Life Sciences / Bioanalysis / Drug Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Ligand binding assay (LBA) development and validation, PK and ADA bioanalysis, ELISA, ECL (MSD), Gyrolab, regulatory compliance (GLP/GCLP), scientific writing, project management, mentorship
Preferred skills
Regulated GLP/GCLP study leadership, client-facing experience in CRO/pharma, process improvement initiatives
Technologies
ELISA, ECL (MSD), Gyrolab
Responsibilities
Design, develop, optimize, and validate ligand binding assays for PK and ADA applications; Analyze biological samples and review analytical data for accuracy and quality; Plan, monitor, and coordinate laboratory activities to meet study timelines; Train and mentor junior scientists; Participate in client meetings and communicate technical findings
Seniority
Senior, hands-on IC with leadership responsibilities
