Director, PDS&T Analytical CMC Development
Core
Drives analytical control strategy for late-stage biologics development, including method development, validation, advanced characterization, and regulatory authoring for gene therapy and tLNP technologies.
Role type
Director, Analytical CMC Strategy
Builds
Late-phase to commercial method development, optimization, validation, and control strategies for biologics
Domain
Biopharmaceuticals / Gene Therapy / tLNP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic thinking, complex project management, cross-functional communication, risk-based comparability strategy, regulatory authoring, resource management, FTE planning
Preferred skills
Innovation history, influence across scientific disciplines
Technologies
Gene therapy platforms, tLNP technologies
Responsibilities
Drive overall analytical control strategy including specifications and critical quality attributes; Establish collaborations for BLA enabling activities; Set team strategies and define risk mitigation; Communicate project strategy and escalate risks; Act as principal contact for stakeholders; Participate in yearly FTE planning
Seniority
Director, strategic leadership & cross-functional management