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 500 professionals operating from 7 sites in Belgium (Gent), The Netherlands (Amsterdam, Oss, Assen), Spain (Pamplona), 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 Business Unit Drug Product Development and Manufacturing (DDM) based in Ghent (Belgium), we are looking for a
ASSOCIATE ANALYTICAL SCIENTIST – COMPLIANCE OFFICER
WHAT YOU WILL WORK ON
Ardena Gent guides a worldwide portfolio of customers through the processes of formulation and analytical development, the 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.
YOUR KEY RESPONSIBILITIES
- You prepare, perform and report development and quality control analyses according to method descriptions and protocols
- You validate analytical methods
- You review analytical data according to GMP standards and in line with the expectations of the applicable phase of development
- You provide active input related to the correct implementation and handling of the related quality processes such as good documentation practices, handling of non-conformances, ...
- You plan, organize and control the attributed analytical package or the compliance verification of the attributed analytical data
- You communicate and interact with compliance colleagues, lab management and QA for the compliance aspects of the job. For the analytical aspects you also interact with the formulation scientists
- You initiate and document investigations and non-conformances
- You support in the training of compliance -related topics to the team of the Analytical Development department
You report to the Group Leader Analytical Development
YOUR PROFILE LOOKS LIKE/ RESEMBLES
- You have a Bachelor or Master’s degree in science
- You have 2 to 3 years of relevant professional laboratory experience e.g. chromatography (HPLC, UPLC, GC), dissolution, Karl Fisher and spectrometry (UV-VIS, IR) in a GMP environment
- Ideally, you have a first experience in the verification of analytical data according to GMP standards
- You have an eye for quality and compliance and you are able to apply compliance guidelines on real-life data
- You have attention for details, but you keep an eye on the bigger picture
- You have good risk assessment capabilities
- You are flexible, a problem solver and a team player
- You have an analytical mindset and you are stress resistant
- You are fluent in English (written as well as spoken)
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
Ready to apply? Please click on the application button
Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in the European Union) will not be given a status update.
Agency calls will not be appreciated.