Senior Director, Process Technology & Engineering
Core
Lead the Oral and Inhalation Process Engineering group to design and scale up manufacturing processes for drug products and deliver technology transfer to commercial sites.
Role type
Senior Director, Process Technology & Engineering
Builds
Manufacturing processes for oral and inhalation drug products
Domain
Pharmaceutical manufacturing / CMC
Deliverable
production ML models
Required skills
Strategic and operational leadership, team management (20-30 engineers), late-stage CMC project delivery, regulatory submission support (Module 3), process scale-up, digital transformation (data science/AI), cross-functional influence
Preferred skills
Advanced degree (Master's/PhD), continuous drug product processing, parenteral development, GMP/regulatory validation, external manufacturing partner management
Technologies
Data science, predictive modelling, AI, automation
Responsibilities
Provide strategic and operational leadership to the Process Engineering group, manage a global team of 20-30 engineers, guide strategy for late-stage development goals, take responsibility for Module 3 regulatory submissions, implement new practices for efficiency and agility, develop digital approaches to process engineering, partner with CMC Project Leadership, set direction and motivate staff
Seniority
Senior Director, hands-on leadership & strategy