Research Scientific Associate Director - Process Development
Core
Leading process development and CMC clinical studies for plasma-derived therapies to improve product quality and manufacturing operations.
Role type
Senior IC process development lead (plasma-derived therapies)
Builds
Plasma-derived therapeutic products and manufacturing processes
Domain
Pharmaceutical industry, biotechnology, plasma fractionation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
process development, plasma fractionation and purification, CMC drug substance matrix leadership, statistical/mechanistic/hybrid modelling, GxP compliance, vendor management, team mentoring
Preferred skills
DFSS concepts, advanced process/protein modelling, data analysis and management
Technologies
None explicitly stated
Responsibilities
Lead pipeline programs from feasibility through late-stage development; oversee project execution with stakeholders; act as SME for process optimization and tech transfer; review technical documents and author submission materials; drive software tool development for process efficiency; coach and mentor staff; manage external R&D collaborations and CDMO visits
Seniority
Senior, hands-on IC with strategic oversight
