Director, Formulation Development
Core
Lead formulation strategy, innovation, and commercial readiness for sterile and nonsterile pharmaceutical pipelines in a 503A/503B environment.
Role type
Director, Formulation Development
Builds
Personalized medications and pharmaceutical products for patients nationwide
Domain
Healthcare / Pharmaceutical Manufacturing
Deliverable
production ML models | product features
Required skills
Pharmaceutical formulation development, technology transfer, process optimization, regulatory compliance, cross-functional leadership, talent development, risk management, scalability strategy, AI integration, data-driven decision making
Preferred skills
Experience with AI-enabled analytics, predictive modeling, digital experimentation tools, automation, and advanced technologies
Technologies
AI analytics, predictive modeling, digital experimentation tools, automation, data visualization, knowledge management systems
Responsibilities
Lead formulation strategy across sterile and nonsterile pipelines; Establish formulation roadmaps for pipeline expansion; Direct scientific governance frameworks; Oversee formulation development from feasibility through commercial readiness; Lead formulation optimization initiatives for scalability and manufacturability; Resolve complex scientific and operational challenges; Build partnerships across quality, manufacturing, regulatory, and commercial teams; Recruit and develop high-performing scientific talent; Ensure compliance with regulatory requirements and internal quality systems; Lead risk management activities for formulation development and scale-up; Drive scalable formulation and process strategies; Champion advanced technologies and AI capabilities; Lead continuous improvement initiatives
Seniority
Director, strategic leadership & cross-functional execution
