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 (Oral and Inhalation)
Required skills
Strategic and operational leadership, CMC and pharmaceutical product development, scale-up and manufacturing science, regulatory submissions (Module 3), team management and succession planning, process control strategies, matrix organization influence, digital tools and AI for process engineering
Preferred skills
Advanced degree (Master's/PhD), 15+ years experience, continuous drug product processing (CDC), parenteral drug product development, GMP and process validation knowledge, 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 teams in developing strategies for late-stage development goals, take responsibility for the full drug product package in regulatory submissions, lead implementation of new practices for efficiency and agility, develop innovative approaches using data science and AI, partner with CMC Project Leadership on project portfolio strategy, set direction and motivate staff