Director Process Development Opportunity

3 weeks ago


Thousand Oaks, California, United States Amgen Full time
About the Role

We are seeking a highly skilled and experienced Director of Process Development and Biologics to join our team at Amgen. As a key member of our leadership team, you will be responsible for providing scientific, technical, and managerial leadership in support of late-stage biologic drug product development.

Key Responsibilities
  • Lead a high-performing technical team, fostering diversity in scientific and engineering skills.
  • Interface seamlessly with partners in Process Development, Quality, Regulatory, and Manufacturing to optimize drug product development.
  • Provide visionary leadership in devising strategies and experimental plans for drug delivery, emphasizing biological efficacy, ease of administration, and enabling target product presentations.
  • Efficiently organize and leverage resources for maximum output while fostering innovation.
  • Develop and communicate a compelling department vision, aligning each team member's work with the broader organizational goals.
  • Navigate ambiguity and rapid changes adeptly, smoothly transitioning and rallying the team when needed.
  • Guide and mentor team members in day-to-day performance, long-term career development, and during times of change.
  • Possess expertise in process engineering, pharmaceutical sciences, formulation development, and drug delivery technologies.
  • Regularly engage with senior management and executives, shaping comprehensive departmental direction.
  • Contribute to regulatory filings, including INDs, CTAs, and MAs; assist in addressing regulatory authorities' inquiries as needed.
  • Rigorously review all scientific and regulatory deliverables.
Requirements
  • Doctorate degree and 4 years of Process Development experience
  • OR Master's degree and 8 years of Process Development experience
  • OR Bachelor's degree and 10 years of Process Development experience
  • Minimum of 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.


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