Ardena is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development services. The Ardena Group is operating from six sites in Europe.
For the Ardena branch based in Mariakerke (Gent, Belgium), we are looking for a
Group Leader Analytical Sciences
Your key role
Ardena Gent guides a worldwide portfolio of customers through the processes of formulation and analytical development, preparation of regulatory dossiers and the manufacturing and labeling of early-phase clinical materials according to GMP appropriate standards.
The analytical laboratory plays a key role in the development and validation of analytical methods to characterize drugs and to perform quality control testing on incoming raw materials and on the finished clinical materials.
You act as technical expert with respect to analytical method development and GMP QC analysis.
You are the first point of contact for all analytical challenges within the company.
Your key responsibilities
- You are the technical expert concerning analytical method development and GMP QC analysis:
- You translate customer project goals into high-quality analytical methods
- You are the analytical expert in the project team meetings
- You function as analytical problem solver in the department
- You are responsible for the implementation of new analytical techniques in the lab in close collaboration with the engineering department
- You are responsible for the day to day management, planning and support of the (Associate) Analytical Scientists performing development and GMP analytical activities (development of methods, installation of methods, analyses of samples, validation of methods, QC release testing, GMP stability studies)
- You report to the Director Analytical Sciences
- You have a PhD with scientific orientation (Pharmaceutical Sciences, Bioscience- Engineering, Science or Chemical Engineering, Industrial Engineering, Chemistry …) or equivalent by experience.
- You have profound experience in development of chromatographic analytical methods such as HPLC, UPLC, GC (and MS detection systems) and spectroscopic techniques such as UV-Vis, FTIR
- Experience in CMC method development is a plus
- Experience in a GMP environment is a plus
- You are able to run development projects independently and to keep an eye on budget and timelines
- You are able to motivate the analysts of the project team
- You have a strong interest in drug research and development and the associated analytical development.
- You are familiar with MS Office (knowledge of Empower is an asset)
- You have strong analytical and reporting skills (oral, written, presentations)
- You are a team player
- You show flexibility and you are open-minded and change oriented (always looking for ways to improve).
- An attractive remuneration package with extra-legal benefits such as meal vouchers and group/hospitalization insurance and a bonus system
- Ability to grow your skills in a rapidly growing company with international customer portfolio
- A dynamic working environment