CMC Project Manager
4 days ago
We are seeking a skilled CMC Project Manager to lead our team in the development of new drugs. As a key member of our Global CMC-Development team, you will be responsible for managing projects from pre-clinical to clinical phases and ensuring timely delivery of high-quality results.
About the Role:
You will work closely with cross-functional teams to prepare project plans, manage timelines, and oversee budgets. Your expertise in biologics and experience working with contract development and manufacturing organizations (CDMOs) will be invaluable in this role. You will represent the Global CMC area in the Project Core Team and report to the VP, Pharmaceutical Development.
Main Responsibilities:
- Chair the CMC project team and ensure clear direction, communication, and cross-functional cooperation and alignment.
- 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 Profile:
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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