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 320 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 Business Unit based in Oss, we are looking for a Lead Analyst QC, Analytical sciences (fulltime)
WHAT YOU WILL WORK ON
You will work, as member of the QC team, on the release and stability analyses of a number of our late-stage projects related to API and nanomedicines. Furthermore, the QC team will provide analytical support for a range of projects. The analytical support consists of chemical-physical analytical techniques as well as chromatographic techniques.
YOUR KEY RESPONSIBILITIES
- Perform analyses and verification on behalf of the projects;
- Act as the primary contact of designated projects for all its analytical activities (study director);
- Prepare the team planning and sort-out priorities of the work in the QC-team to assist your colleagues in the performance of their work;
- Organize the day-to-day activities of the team;
- You will report to the Team Lead QC.
- Develop the way of working of the QC team, e.g. by developing/writing procedures in close collaboration with the Team Lead QC;
- Assist in the management of the stability facilities and outsourcing activities;
- Take charge in Quality Documentation, like deviations, out of specifications, change controls and CAPA’s;
YOUR PROFILE LOOKS LIKE/ RESEMBLES
- You have >10 years of experience in Quality Control of API’s or Pharmaceutical Products in development;
- You have good knowledge of cGMP guidelines and Pharmacopeia’s;
- You are experienced in translating these guidelines into workable SOP’s;
- You have a pragmatic approach towards GMP;
- You like to help/guide others;
- You feel comfortable in a dynamic and changing environment, you are the proverbial tower of strength;
- You have a great sense of ownership;
- 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 Dutch and 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 developing and growing international company with an attractive 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
- 28 days holiday a year
- Fruit & Fitness possibilities
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.