Senior Manager Stability

Amgen

Gmp compliance for pharmaceutical stability
Leading cross-functional teams in matrix environment
Annual product review data preparation
The Senior Manager Stability will provide governance and management of lean, harmonized, and compliant stability data packages for all of Amgen's products

Job Summary

  • The Senior Manager Stability will provide governance and management of lean, harmonized, and compliant stability data packages for all of Amgen's products.
  • This role requires strong expertise in GMP compliance, staff management, and navigating complex matrixed team environments to support global Product Quality Teams.
  • Successful candidates will oversee stability strategies, manage annual product reviews, and ensure readiness for audits and inspections across the manufacturing network.

Matching Summary

The Senior Manager Stability will provide governance and management of lean, harmonized, and compliant stability data packages for all of Amgen's products.

Skills & Requirements

Must-have

  • GMP compliance for pharmaceutical stability
  • Leading cross-functional teams in matrix environment
  • Annual product review data preparation
  • ICH regulatory guidance knowledge
  • Stability strategy and lifecycle management

Nice-to-have

  • Experience with Veeva Spotfire and LIMS applications
  • Continuous improvement mindset applying lean principles
  • Expertise in biologic and synthetic drug manufacturing
  • Strong presentation skills for leadership updates

Key Requirements

  • Doctorate degree plus 8 years experience OR Master's plus 12 years OR Bachelor's plus 15 years
  • B.S. or advanced degree in chemistry, biochemistry, biology, or related field
  • Proven experience leading cross-functional teams in a matrix environment

Work Rights

Not specified

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