Director, Biologics Development
Core
Leads strategy and execution of biologics development activities to advance therapeutic programs from early-stage development through clinical and commercial readiness.
Role type
Director, Biologics Development (Senior, hands-on IC)
Builds
Second-generation manufacturing processes for proprietary bioconjugation platform biologics
Domain
Biopharmaceuticals / Neuromuscular diseases
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
biologics process development, CMC strategy definition, CDMO management, technology transfer, regulatory filing authoring (Module 3), protein expression and purification, analytical development, cross-functional leadership
Preferred skills
advanced degree in biology/biochemistry/pharmaceutical sciences, experience with FDA/EMA/ICH guidelines
Technologies
bioconjugation platform, cGMP documentation systems
Responsibilities
Lead design and optimization of scalable biologics manufacturing processes; Act as primary CMC representative to internal teams and external partners; Lead selection and strategic management of external CDMOs; Author and review global regulatory filings (IND, IMPD) including Module 3 sections; Review and approve critical development and cGMP documentation.
Seniority
Director, strategic leadership & technical execution
