• Define project scope based on customer needs
• Developing project design (content, overall plan, budget, timelines) together with Ardena Gent DDM technical experts
• Draft Statement of Work and follow-up approval process
• Planning, management, coordination, and financial control of approved projects
• Leading the core project team (including DDM galenic lead, analytical lead and QP) and clearly communicating the agreed strategy and deliverables to all stakeholders
• Draft and follow up on the Technical Quality Agreement and the Quality Agreement
• Review and approval of scientific protocols and reports
• Conflict resolving; at all times facilitating decision making in order to drive the project forward
• Communicating progress of the project to customer as first point of contact
• Maintaining relationship with existing customers and pro-actively advise customers on next steps/projects for their current and future projects
• You keep yourself up to date with the latest developments and insights
• You will report to the scientific director (director of project management office)
• You will closely work together with our customers and all DDM departments (Formulation & Production, Analytical Development, Quality, Facility & Material Logistics)

• You have a master or PhD degree in a scientific discipline (Pharmaceutical Sciences, Biotechnology, Bioengineering, Biomedical Sciences or similar)
• You have at least 1 to 3 years of experience in CMC
• Hands-on experience in drug product analytical and/or formulation development and/or GMP is a strong added value
• You have excellent planning and organizational skills with demonstrated ability to deliver work on-time
• You are customer-oriented
• You are flexible, a problem solver and a team player
• You have an analytical mindset and you are stress resistant
• You have good communication skills and are fluent in English (written as well as spoken)
• You feel comfortable in a dynamic and changing environment
• You like to learn and develop yourself

• A true learning environment where you will have the ability to grow your skills
• A rapidly International developing and growing company with an interesting services, product and customer portfolio
• A dynamic working environment with nice colleagues
• Open straightforward but also caring culture
• We are true to our values
• An attractive remuneration package
• Flexible working hours
• 32 days holiday a year

If you are interested in this position and would like to know more about it, please contact:

Nele Geusens, PhD, Recruitment Consultant
T: +32 497 57 08 94
E: geusens@themagroup.eu