Contract Development And Manufacturing Senior Manager

Amgen Inc

Japan
Strong technical communication in japanese and english
Experience with cgmp principles and fda guidelines
Project leadership for development and commercial manufacture
This role oversees Amgen Contract Development and Manufacturing sites through executing activities according to Good Manufacturing Practices (cGMP) principles

Job Summary

  • This role oversees Amgen Contract Development and Manufacturing sites through executing activities according to Good Manufacturing Practices (cGMP) principles.
  • The successful candidate will lead external projects spanning development, clinical, and commercial manufacture while coordinating with technical and functional leads.
  • Amgen offers vast opportunities to learn and move up across the global organization within a diverse and inclusive community.

Matching Summary

This role oversees Amgen Contract Development and Manufacturing sites through executing activities according to Good Manufacturing Practices (cGMP) principles.

Skills & Requirements

Must-have

  • Strong technical communication in Japanese and English
  • Experience with cGMP principles and FDA guidelines
  • Project leadership for development and commercial manufacture
  • Ability to pivot between synthetic and biologic modalities
  • Managing purchase orders and financial forecasting

Nice-to-have

  • Self-starter comfortable with ambiguity and complexity
  • Strategic thinking and business acumen
  • Experience interacting with domestic and international suppliers
  • Understanding of import and export policies
  • Continuous improvement and operational excellence skills

Key Requirements

  • Doctorate degree plus 2 years experience OR Master's plus 6 years OR Bachelor's plus 8 years
  • Professional fluency in English including written and verbal skills
  • 8+ years proven experience in Pharmaceutical Manufacturing
  • 3+ years of project management experience leading multi-functional teams
  • 5+ years working knowledge of cGMP principles and regulatory guidelines

Work Rights

Must be regionally based in Japan; language fluency required

Tailored Resume

Cover Letter