Group Leader Formulation and Production.
Ardena is a leading contract development organization for the pharmaceutical industry. They assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. They 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.
They 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 them by becoming their next colleague? Then we might have the right opportunity for you!
- Translate the input from the Project Managers to tasks on the work-floor
- Review Technical Quality Agreement and drafts the internal instructions
- Draft and train Master Batch Record Documentation and Batch Record Documentation templates and ensure their strict use
- Coordinate the purchase and the availability of starting materials prior to start of GMP Production
- Plan and follow up the GMP Production activities, areas and equipment
- Assist the Associate scientists in documenting non-conformances to guarantee the quality and compliancy
- Communicate with QA for follow up and strategy to be followed for non-conformances
- Responsible for resolving and discussing quality related issues with QA/QP
- Write the GMP manufacturing reports
- Assist in meeting with Contract Givers
- You report to the Director Formulation and Production
Profiel van de kandidaat.
- You have a master or a PhD with scientific orientation (Pharmaceutical Sciences, Bioscience-Engineering, Science or Chemical Engineering, …) or equivalent by experience
- You have hands-on experience with the preparation of different galenic forms (oral and/or parenteral dosage forms) and knowledge of the process to produce different galenic forms
- Experience in a GMP environment is mandatory
- Experience in aseptic fill and finish activities is preferred
- Experience in formulation development is an asset
- You have strong coordination and organization skills
- You are able to coach and motivate the operators/scientists executing the work
- You have strong 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)
- 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