Team Leader, Immunoanalysis
Core
Lead a team of Study Directors and Technicians in regulatory bioanalysis (PK, PD, ADA) for clinical development within a CRO.
Role type
Senior management IC (Immunoanalysis Team Leader)
Builds
Production bioanalytical assays and data for pharmaceutical/biotech partners
Domain
Clinical research / Bioanalysis / Immunogenicity
Deliverable
Production ML models | product features | dashboards & analysis | client delivery
Required skills
Regulatory bioanalysis expertise, Immunogenicity testing, Large molecule analysis, Team leadership, GCP/GLP compliance, Client relationship management, Assay optimization, Troubleshooting, Revenue target achievement
Preferred skills
MSD platform proficiency, Gyrolab platform proficiency, ELISA platform proficiency
Technologies
MSD, Gyrolab, ELISA
Responsibilities
Leading and mentoring a team of 8 Study Directors and ~12 Technicians, Supervising complex bioanalytical studies, Driving optimization and troubleshooting, Managing international client relationships, Ensuring compliance with GCP/GLP/FDA/ICH M10, Achieving laboratory revenue targets
Seniority
Senior, hands-on IC with management responsibilities