Project Management Professional in CMC

4 days ago


Copenhagen, Copenhagen, Denmark ALK-Abelló AS Full time
Role Summary:

We are seeking a skilled CMC Project Manager to join our team and lead the development of new drugs. This is an exciting opportunity to contribute to the growth of our company and work collaboratively with a diverse team of experts.

About the Position:
This role involves managing projects from pre-clinical to clinical phases, working closely with cross-functional teams, and ensuring timely delivery of high-quality results. You will be responsible for representing the Global CMC area in the Project Core Team and ensuring CMC deliverables align with overall project expectations and managing stakeholders.

Main Responsibilities:
- Develop and maintain CMC project plan, timeline, and project budgets and oversee the progress of our internal CMC activities.
- Represent G-CMC in the Project Core Team and ensure CMC deliverables align with overall project expectations and manage stakeholders.
- Oversee the relationship and communication with our CDMO, ensuring alignment with project timelines, deliverables, and regulatory requirements.
- Identify potential CMC project risks and issues and proactively implement mitigation strategies.
- Collaborate with the management team and scientific experts to support the development of our strategy for in- and outsourcing activities within Biologics.

Your Skills:
We are looking for a candidate with an educational background in engineering, natural science, or equivalent, and a minimum of 5 years of experience in drug development, biologics. You should have proven project manager skills from a development environment, ability to lead cross-functional teams, and good analytical skills. Fluency in English, both orally and in writing, is essential.

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