CMC Project Manager

About the role

ICON, a global healthcare intelligence and clinical research organisation, is looking for a CMC Project Manager to join its team in Mechelen. The role is fully embedded in an innovative biotech focused on immunology, where scientists and antibody engineers work together to discover novel targets and therapeutic antibodies. You will lead and manage regulatory affairs CMC projects, ensuring their successful execution and delivery.

Key responsibilities

• Achieve project goals, including timelines, budget and scope
• Translate the scientific strategy into a CMC project plan with the support of CMC leads, defining timelines, dependencies and budget needs
• Track, monitor and report key milestones and decision points, balancing scope, cost, timelines and risk
• Build strong relationships with internal and external stakeholders and monitor progress
• Perform critical path analysis and risk assessment, coordinating critical path items and escalating risks with the project team
• Run scenario simulations and advise on optimal development planning
• Prepare and lead project team meetings, including agendas, action items and minutes
• Promote collaboration, effective communication and cross-functional problem-solving

Required profile

• Degree in Life Sciences
• Strong CMC project experience
• Experience working with biologics
• Experience with CMC teams and CMC vendors is strongly preferred
• Legal right to work in the country where the role is based

Required skills

• Planning, organisation and multi-tasking in a multicultural environment
• Analytical, problem-solving and critical thinking skills
• MS Project, Power BI or Planisware experience

What we offer

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes, including medical, dental and vision coverage where applicable
• Retirement and pension plans, life assurance and disability coverage
• Employee assistance programmes and learning and development opportunities