Director, VTR Biologics and AIV
Core
Lead VTR (Validation, Transfer, and Registration) and AIV (Analytical Instrument Validation) teams to ensure analytical readiness for late-stage clinical and commercial biologics and combination drug products.
Role type
Director, Biologics VTR and AIV
Builds
New product launches, market registrations, and sustained patient supply for commercial products
Domain
Biopharmaceuticals / Analytical Sciences / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Method validation, regulatory filings, GMP compliance, cross-functional leadership, budget management, analytical instrument validation, dossier authoring, lifecycle management
Preferred skills
Advanced degree in Life Sciences, experience with FDA/EMA/PMDA/CFDA regulations, CMC product lifecycle knowledge
Technologies
GMP environments, analytical method development tools, quality management systems (CAPA, deviations, change control)
Responsibilities
Lead and oversee method validation, transfers, regulatory filings, and global product launches; Implement advanced process control technologies to modernize control strategies; Ensure analytical instrument validation for GMP testing environments; Manage projects, timelines, resources, and budgets; Evaluate and apply new technologies in GMP environments; Drive innovation and operational efficiency; Ensure robust and compliant GMP testing methods; Facilitate cross-functional alignment; Direct VTR managers and scientists in method development and lifecycle management; Oversee quality initiatives such as CAPA, deviations, and change control
Seniority
Director, Management level
