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. We strongly believe that our multidisciplinary approach can accelerate the drug development and approval process. By seamlessly integrating our services, we’re able to better mitigate development risks and ultimately reduce time-to clinic.
Ardena is a rapidly growing international orientated organization in the industry, with 6 company sites in 4 countries. (Belgium, the Netherlands, Latvia and Sweden). In the past 3 years we have taken over several other organizations which are complementary to each other and created One Ardena Group. We currently have 300 people working for us and an annual revenue of 44 million euro (2020) and have realized an average growth of 15% on annual basis over the past 3 years and we have the ambition to continue this growth.
The Ardena site in Oss, The Netherlands, is specialized in chemical process and analytical development and cGMP manufacture of Active Pharmaceutical Ingredients (API) and nanomedicines.
For this Business Unit, we are looking for a
Team Lead QC for development, Analytical sciences (fulltime)
WHAT WILL YOU WORK ON
You will work, with your team, on the release and stability analyses of a number of our late-stage projects related to API and nanomedicines. Furthermore, you and your 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
- Build and lead the newly formed QC team (6-8 people);
- Further develop the way of working of the QC team, e.g. by developing/writing procedures;
- Keep up-to-date with the latest insights in GMP and Pharmacopeia’s. Implement pharmacopeial changes in the organization;
- Manage the stability facilities and outsourcing activities;
- Take charge in Quality Documentation, like deviations, out of specifications, change controls and CAPA’s for your QC-team;
- You will report to the Director of the Analytical Sciences department (37 people).
YOUR PROFILE LOOKS LIKE/ RESEMBLES
- You have >8 years of experience in Quality Control of API’s or Pharmaceutical Products in development;
- You have >4 years of experience as a manager of a QC group;
- You have good knowledge of cGMP guidelines and Pharmacopeia’s;
- You are experienced in translating these guidelines into workable SOP’s;
- You are recognized for your pragmatic approach towards GMP;
- You like to share and transfer your knowledge;
- You feel comfortable in a dynamic and changing environment;
- You like to learn and develop yourself;
- 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 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 love creative thinking and pro-activeness;
- We are true to our values.
Next to that we also offer of course:
- An attractive remuneration package;
- Flexible working hours;
- 28 days holiday a year;
- Fruit & Fitness possibilities;
- The office is easy to reach by public transport.
If you like to have more information about the role, please do not hesitate to contact Paul van Tilborg, email: Paul.vanTilborg@ardena.com, Tel: +31 412 846 075
Ready to apply? send us your cv and motivation letter via our website ardena.com/careers or email at email@example.com
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 Netherlands) will not be given a status update.