Group leader formulation and production

  • Ghent, BE
  • 4 months ago

 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.

The Ardena Group is operating from six sites in Europe. For the Ardena branch based in Mariakerke (Gent, Belgium), we are looking for a

Group leader formulation and production 

Your key role

Ardena Gent guides a worldwide portfolio of customers through the processes of formulation and analytical development, preparation of regulatory dossiers and the manufacturing and labeling of early-phase clinical materials according to GMP appropriate standards.

The Formulation and Production Team plays a key role in the development of API-tailored formulations and transfer the technology into GMP, for clinical material production.

The main task of the Group Leader Formulation and Production is the planning, preparation and follow up of the assigned formulation development and GMP production projects.  The Group Leader Formulation and Production is responsible for the day to day management, planning and support of the Formulation Scientists and Production Operator performing formulation development and GMP production activities with the aim of facilitating progression of the activities, troubleshooting on technical issues and guaranteeing that the deliverables are met within budget and time and in accordance of the requirements of the GMP Quality system.

In addition, you act as technical expert with respect to formulation development and GMP production activities:

  • You function as scientific and technical problem solver in the Formulation and Production department
  • You function as representative of the formulation and production team in project core meetings

Your key responsibilities

  • Translates 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 Production Operators 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
  • Support the Formulation Scientists in the execution of formulation projects
  • Assist in meeting with Contract Givers
  • You report to the Director Formulation and Production

Your profile

  • You have 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 (e.g. powder blending, encapsulation, etc.) and knowledge of the process to produce different galenic forms
  • Experience in formulation development is an asset
  • Experience in a GMP environment is preferred
  • You have strong coordination and organisation 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)

We offer

  • An attractive remuneration package with extra-legal benefits such as meal vouchers and group/hospitalization insurance and a bonus system
  • Ability to grow your skills in a rapidly growing company with international customer portfolio
  • A dynamic working environment

If interested, please contact us and send us your cv and motivation letter via our website ardena.com/careers or email at hr@ardena.com