Director, Process Development - Drug Substance
Core
Lead a new Process Development team at AIN to build capabilities, operating models, and cross-site partnerships for advancing drug substance deliverables for Amgen products.
Role type
Director, Process Development (Drug Substance Technologies)
Builds
New organizational capabilities, operating models, and cross-site partnerships for drug substance technologies
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic planning, team building, resource allocation, budget management, performance metrics analysis, cross-functional partnership, regulatory translation, process improvement, stakeholder management, leadership coaching
Preferred skills
Drug substance process development, manufacturing experience, cGMP regulations, automation/AI/ML tools, statistics/data analytics, project management, Agile methodologies
Technologies
Automation tools, AI, Machine Learning, Large Language Models, Data analytics tools, Project management tools
Responsibilities
Build and lead a new DST team with capabilities in technical documentation, regulatory authoring, data analytics, automation, and process monitoring; Define roles, hire personnel, and implement new processes; Establish communication channels for knowledge sharing; Manage team goals and timelines; Develop staff through supervision and coaching; Strategically plan and manage resources including budget and contractors; Partner to establish operating model and governance framework; Translate business and regulatory needs into execution plans
Seniority
Director, strategic leadership & team building
