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, manufacturing, logistics and bioanalytical services.
Ardena is a rapidly growing international orientated organization with a dedicated team of about 330 professionals operating from 6 sites in Belgium (Gent), The Netherlands (Amsterdam, Oss, Assen), Sweden (Sodertalje), and Latvia (Riga). Ardena has an open and transparent culture: team-spirit, an open mindset and ownership are important values in our company.
We are a dynamic drug developer offering exciting career opportunities to skilled and motivated people who want to work in a fast-growing market within the global pharmaceutical industry. Do you want to work in a challenging contract research and development environment, where experts come together to develop innovative drugs for unmet medical needs? Do you want to further develop Ardena and grow with us by becoming our next colleague? Then we might have the right opportunity for you.
For the Ardena DDM Business Unit based in Ghent (Belgium), we are looking for a
WHAT YOU WILL WORK ON
Ardena Gent guides a worldwide portfolio of customers through the processes of formulation and analytical development and the manufacturing and labeling of early-phase clinical materials according to GMP appropriate standards.
The Analytical Development Department 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.
As an Analytical scientist, you are part of the project Core Team and you are as a scientific expert responsible for setting up the analytical development strategy for drug development projects of new chemical entities in support of (pre)clinical studies and stability studies. The Analytical Scientist independently comes up with the analytical development plan for the project, executes the analytical development work in the lab and writes the related reports. You report to the Group Leader – Analytical Development.
YOUR KEY RESPONSIBILITIES
- Providing technical expertise / scientific input on analytical development strategies
- Preparation and practical execution of analytical development projects
- Providing scientific expertise and analytical insights to Core Team meetings
- Assisting to client meetings to present scientific data in a clear manner
- Writing scientific reports for clients, e.g. method development reports, method validation protocols / reports
- Setting up and monitoring of experiments and ensuring that data are interpreted in a scientifically correct way
- Identifying potential stability issues with the concepts you analyze and detecting the performance issues with early-phase analytical methods
- Performing and documenting the activities in line with GMP standards and regulatory guidelines where applicable
- Actively contributing to improvement projects related to the general lab management to shorten the turnaround times of the analyses and to enhance to delivered quality
- Acting as a scientific mentor for junior colleagues
YOUR PROFILE LOOKS LIKE/ RESEMBLES
- Having a PhD level of education or a scientific master degree (with proven track – 2 yr - in the pharmaceutical field) preferably in (analytical) chemistry or pharmacy or another related life science.
- Adequate development knowledge of analytical techniques for pharmaceutical analysis of small molecules, such as HPLC/UHPLC and Dissolution.
- Excellent oral (presentations) and written (reporting) skills in English
- Flexibility to work in both an R&D and GMP environment
- Experience in a regulated quality control environment (GMP) is an asset
- Self-motivated and able to adapt to changing environment with ease
- Work independently or as part of a team, able to stimulate other co-workers
- Able to deliver results within limited time and budget; solution-oriented
WHAT WE OFFER
- 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 like to have more information about the role, please do not hesitate to contact Stijn Maertens, email: HR@ardena.com, Tel: +32 9 267 65 00
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