Group Leader Formulation
Il y a 5 mois
**About us**
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 **Drug Product Development and Manufacturing (DDM)** team based in Gent (Belgium), we are looking for a
**GROUP LEADER FORMULATION AND PRODUCTION**
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.) will be expanded with aseptic fill and finish 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 production.
The main tasks of the Group Leader Formulation and Production are the planning, preparation and follow up of projects, from Formulation Development up to GMP Production. The Group Leader Formulation and Production is responsible for the day to day management, planning and support of Scientists performing Formulation Development activities, and 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
**YOUR KEY RESPONSIBILITIES**
- Translates the input from the Project Managers to tasks on the work-floor, both in Development and in GMP Production
- Review Technical Quality Agreement and drafts the internal instructions
- Provide technical expertise/scientific input on formulation development strategies
- Assist to client meetings to present scientific data in a clear manner
- Write or review scientific reports for clients, e.g. formulation development reports
- Monitor scientists and their experiments (e.g. process development, implementation of new formulation techniques) and ensuring complex data are interpreted in a scientifically correct way
- Identify potential stability and performance issues with prototype formulations
- Streamline the activities associated with a wide variety of formulation technologies to shorten Formulation Lab turnaround times and improve the quality of formulations being delivered
- 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, including packaging and labelling activities
- 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 or review the GMP manufacturing reports
- Assist in meeting with Contract Givers
- You manage a small team of Scientists working in Development and/or Associate Scientists working in GMP Production
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