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Director, Process Development - Attribute Sciences

Amgen

Amgen seeks a Director to lead Process Development and Attribute Sciences at its Hyderabad facility. This role oversees a diverse team responsible for analytical method development, lifecycle management, and data analytics across the product portfolio, with accountability for building capabilities, partnerships, and operational excellence.

Responsibilities

  • Lead and manage the Attribute Sciences team, maintaining accountability for daily operations and timely completion of goals
  • Build and scale team capabilities, operating model, and cross-site partnerships to advance analytical deliverables across product lifecycle
  • Establish governance, engagement framework, and communication channels with Attribute Sciences teams across Amgen sites
  • Partner with cross-functional teams to develop digital tools, data flows, and analytical processes aligned with customer needs
  • Supervise team members, provide coaching and capability development, manage resources including budget and capacity planning

Requirements

  • Doctorate in analytical sciences, process development, or biotechnology with 8+ years experience; or Master's with 15+ years; or Bachelor's with 20+ years
  • 4 years managerial or team leadership experience directly managing people or programs
  • Expertise in analytical method development, validation, transfer, and lifecycle management for biologics or small molecules
  • Knowledge of cGMP regulations, FDA/EMA requirements, and relevant analytical guidance including ICH Q2 and Q14
  • Proficiency with analytical technologies, data analytics, statistics, and performance metrics for method health assessment
  • Strong leadership capability to build teams, establish new capabilities, and implement effective processes
  • Experience with automation, AI/ML tools in compliant environments and project management or Agile methodologies
Vacancy posted a month ago
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