Director, Process Development
Core
Lead the Drug Product Technologies (DPT) organization at Amgen's AIN site, building a new team and operating model to advance drug product capabilities and deliverables for the global product portfolio.
Role type
Director, Process Development (Strategy & Organization Building)
Builds
A new Drug Product Technologies organization with global capabilities in technical documentation, regulatory support, data analytics, AI-enabled tools, automation, and in-silico modeling.
Domain
Biopharmaceutical manufacturing and process development
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Strategic planning, team building, organizational design, stakeholder management, digital transformation, resource management, performance metrics analysis, cross-functional leadership
Preferred skills
Drug product process development, cGMP regulations, automation/AI/ML tools, regulatory filings, statistics/data analytics, project management, Agile methodologies
Technologies
AI-enabled tools, automation, in-silico modeling, data analytics tools, project management tools
Responsibilities
Build and lead the DPT organization at AIN; define roles, responsibilities, and governance frameworks; develop and scale team capabilities in documentation, analytics, and automation; champion digital transformation; set strategic priorities and execution plans; recruit, onboard, and develop talent; manage budget and resources; drive continuous improvement using performance metrics.
Seniority
Director, hands-on leadership with strategic oversight