Global Pharmaceutical Project Lead
3 days ago
As a Senior CMC Project Manager at ALK-Abelló A/S, you will be part of our Global CMC-Development team. This team is responsible for managing projects in different phases, including pre-clinical, clinical phase III preparations, and Life Cycle Management/optimization projects.
The position involves working closely with cross-functional teams to prepare project plans and execute CMC activities. As a flexible and adaptable mindset is required, you will be able to handle changes that occur within development.
You will represent the Global CMC area in the Project Core Team and report to the VP, Pharmaceutical Development. Your responsibilities will cover:
- Chairing the CMC project team and 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.
Your profile should include:
- 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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