CMC Project Manager – Biotech Division
4 days ago
About the Role
We are seeking a highly skilled and motivated CMC Project Manager to join our Biotech Division, focusing on biosimilar development. This is a unique opportunity to contribute to high-impact projects at a company renowned worldwide for its innovation and excellence in biotechnology.
The role sits within our CMC Coordination Group, part of the Biotech PMO Office, and reports directly to the team lead. You will be responsible for managing complex biosimilar projects in the scale-up phase, ensuring strategic alignment across R&D, manufacturing, and analytical functions.
Key Responsibilities
Lead CMC planning for biosimilar development projects
Define project scope, timelines, and milestones
Align strategic objectives with technical and analytical development
Manage risk assessment, budget planning, and critical path
Collaborate with R&D leaders and manufacturing sites to ensure timely execution
Coordinate and deliver project deliverables across functions
Oversee tech transfer, validation, and market launch activities
Support lifecycle management throughout the development process
Requirements
Degree in Life Sciences (e.g. biotechnology, pharmaceutical sciences, chemistry)
Fluent English (written and spoken)
Solid understanding of GMP regulations
Proven experience in biotech development, ideally with biosimilars
Strong background in tech transfer and CMC lifecycle management
Familiarity with analytical and technical development processes
Project management expertise (scope, budget, risk, scheduling)
PMP certification is not required, but a project leadership mindset is essential
EU citizenship or work permit required
What We Offer
Strategic role in a globally recognized biotech company
Opportunity to lead high-impact biosimilar projects
Collaborative, international work environment
Competitive compensation - with company car
Flexible working hours and hybrid work model
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