CMC Project Director
3 days ago
We are looking for a Senior CMC Project Manager to join our Global CMC-Development team at ALK-Abelló A/S. As a key member of the team, you will be responsible for managing projects in different phases, including pre-clinical, clinical phase III preparations, and Life Cycle Management/optimization projects.
Your key responsibilities will include:
- Leading cross-functional teams to prepare project plans and execute CMC activities.
- Ensuring clear direction and communication, as well as cross-functional cooperation and alignment.
- Developing and maintaining CMC project plans, timelines, and budgets, and overseeing the progress of internal CMC activities.
- Representing G-CMC in the Project Core Team and ensuring CMC deliverables are aligned with overall project expectations, and managing stakeholders.
- Overseeing the relationship and communication with our CDMO, ensuring alignment with project timelines, deliverables, CDMO budget, and regulatory requirements.
- Identifying potential CMC project risks and issues and proactively implementing mitigation strategies.
Our ideal candidate should have:
- An educational background with a master's degree in engineering, natural science, or equivalent.
- Minimum 5 years of experience within drug development, Biologics.
- Proven project management skills from a development environment and ability to lead cross-functional teams.
- Good analytical skills and ability to focus on the critical path and prepare mitigation strategies.
- Adaptability and solution-orientedness, ready to lead the project team to success with a high scientific standard.
- Strong communication skills and fluency in English, both orally and in writing.
- Preferably experience within drug development, regulatory filings, and requirements.
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