Director Process Development Opportunity
3 weeks ago
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.
- 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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Director of Biologics Process Development
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