Senior Director - Head of Process Engineering (Synthetic Drug Substance Process Development)
Core
Lead a global organization of 30+ scientists and engineers to drive technical and strategic solutions for the development, characterization, technology transfer, and lifecycle management of synthetic and hybrid drug substance manufacturing processes.
Role type
Senior Director, Head of Process Engineering (Synthetic Drug Substance)
Builds
Early- and late-phase clinical and commercial synthetic/hybrid drug substance manufacturing processes
Domain
Pharmaceutical manufacturing, small molecule/hybrid process development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic oversight of process development portfolios, global organizational leadership, regulatory filing authorship and review, cross-functional collaboration with CDMOs, process optimization and cost reduction, talent development and succession planning, budget and resource allocation, technology transfer management, quality risk management, statistical data analysis, executive-level communication
Preferred skills
PhD in Chemical Engineering, 10+ years in synthetic/hybrid pharmaceutical process development, managing organizations of 20+ staff, expertise in small molecule/peptide/oligonucleotide/bioconjugate development, cGMP operations, scale-up and commercialization, quality by design principles, active engagement in scientific community (publications/patents)
Technologies
cGMP operations, technology transfer, scale-up, PPQ validation, regulatory filings (IND/MAA), quality risk management tools
Responsibilities
Lead global process engineering team, provide strategic oversight for synthetic/hybrid portfolio advancement, establish engineering business platforms, strengthen technical capabilities, author/regulatory filings, foster safety/compliance culture, recruit and develop high-performing team, manage portfolio prioritization and budget, partner with manufacturing/CDMOs for technology transfer, drive innovative technology deployment, contribute to scientific eminence via publications/patents, serve on DSTS Leadership Team
Seniority
Senior Director, hands-on IC with organizational leadership
