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Group Leader Formulation Development
il y a 2 semaines
As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, **Ardena** is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated portfolio covering drug substance and drug product development, manufacturing, logistics, and bioanalytical services.
With a rapidly growing international orientation, Ardena boasts a team of 500+ professionals operating across five strategically located sites. Our presence spans Belgium (Gent), The Netherlands (Oss and Assen), Spain (Pamplona), and Sweden (Södertälje). Embracing an open and transparent culture, we hold team spirit, an open mindset, and ownership as key values within our organization.
We are a dynamic force in drug development, offering compelling career opportunities to skilled and motivated individuals seeking to make their mark in the rapidly expanding global pharmaceutical industry. If you're looking to thrive in a challenging contract research and development environment, collaborating with experts to innovate drugs for unmet medical needs, Ardena could be the ideal workplace for you.
For the Ardena Business Unit **D**rug**P**roduct**D**evelopment and**M**anufacturing (DDM)** based in Mariakerke (Gent, Belgium), we are looking for a
**GROUP LEADER**FORMULATION DEVELOPMENT & MANUFACTURING**
The Ardena DDM Business unit located in Belgium provide clients with a full-service solution from formulation development, analytical method development and validation, demo batch production, stability studies, clinical GMP batch production, QC testing, labelling and randomization, QP release, storage and shipping through to regulatory support for molecules in the early phase of development. In 2022 our current drug product services in oral dosage forms (granules, capsules, tablets, solutions, etc.) expanded with aseptic fill and finish (F&F) capabilities for the development and clinical production of small and large molecule injectable formulations.
**YOUR KEY ROLE**
The Formulation and Production Team plays a key role in the development of formulations and transfer of the technology into GMP, for clinical material manufacturing.
The main task of the Group Leader Formulation and Production is the planning, preparation and follow up of the assigned GMP production projects. The Group Leader Formulation and Production is responsible for the day to day management, planning and support of the Associate Scientists performing GMP production activities with the aim of facilitating progression of the activities, troubleshooting on technical and GMP compliance 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 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 once the project enters the GMP manufacturing stage
**YOUR KEY RESPONSIBILITIES**
- Lead a team of Associate Scientists
- Translates the input from the Project Managers to executable 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
- Assist in the GMP Production area hands-on in case of capacity constraints
- Write the GMP manufacturing reports
- Assist in meetings 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 MSc in Pharmaceutical Sciences with GMP experience
- You have a strong understanding of the process and preparation of different galenic forms (oral and topical dosage forms)
- Experience in a GMP environment is a big plus
- 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 remuneratio
