Group Leader Formulation

il y a 4 semaines

Gent, Belgique Ardena Temps plein

**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
-

  • Group Leader Formulation Development

    il y a 2 semaines

    Gent, Flandre, Belgique Arcadis Temps plein

    Group Leader Formulation Development & ManufacturingThe 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...

  • Group Leader Formulation Development

    il y a 6 jours

    Gent, Flandre, Belgique Arcadis Temps plein

    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...

  • Group Leader Formulation Development

    il y a 11 heures

    Gent, Flandre, Belgique Arcadis Temps plein

    YOUR KEY ROLEThe 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...

  • Group Leader Formulation Development

    il y a 2 semaines

    Gent, Flandre, Belgique Ardena Careers Temps plein

    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...

  • Group Leader Formulation Development

    il y a 7 jours

    Gent, Flandre, Belgique Ardena Temps plein

    As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, Ardenais 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...

  • Group Leader Formulation Development

    il y a 15 heures

    Gent, Flandre, Belgique Ardena Temps plein

    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...

  • Group Leader Formulation Development

    il y a 4 semaines

    Gent, Belgique Ardena Temps plein

    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...

  • Formulation Development Team Lead

    il y a 2 jours

    Gent, Flandre, Belgique Arcadis Temps plein

    Job DescriptionThis role involves leading a team of Associate Scientists in the development and production of formulations, ensuring compliance with GMP regulations. Key responsibilities include planning and executing GMP projects, reviewing technical quality agreements, and drafting internal instructions.Main Responsibilities:Lead a team of Associate...

  • Formulation Scientist

    il y a 4 semaines

    Gent, Belgique Ardena Temps plein

    For the Ardena DDM Business Unit based in Ghent (Belgium), we are looking for a **FORMULATION SCIENTIST** **WHAT YOU WILL WORK ON** **Ardena Gent **guides a worldwide portfolio of customers through the processes of formulation and analytical development and the manufacturing and labeling of early-phase clinical materials according to GMP appropriate...

  • Formulation Scientist

    il y a 3 semaines

    Gent, Belgique Ardena Temps plein

    **About us** **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, manufacturing,...

  • Director Formulation Development and Production

    il y a 4 semaines

    Gent, Belgique Ardena Temps plein

    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...

  • Senior Formulation and Production Manager

    il y a 1 jour

    Gent, Flandre, Belgique Arcadis Temps plein

    About the RoleThe Formulation and Production Team plays a critical role in developing formulations and transferring technology into GMP for clinical material manufacturing. As a Group Leader, you will be responsible for planning, preparing, and following up on assigned GMP production projects.Main TasksPlan and prepare GMP production projectsManage...

  • Director Formulation Development and Production

    il y a 2 semaines

    Gent, Flandre, Belgique Ardena Careers Temps plein

    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...

  • Director Formulation Development and Production, East Flanders

    il y a 7 jours

    Gent, Flandre, Belgique TN Belgium Temps plein

    Social network you want to login/join with:Director Formulation Development and Production, East FlandersClient:Location:Job Category:OtherEU work permit required:YesJob Reference:ad0180e0fc10Job Views:14Posted:03.03.2025Expiry Date:17.04.2025Job Description:As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical...

  • Group Leader Analytical Development Large Molecules

    il y a 5 heures

    Gent, Belgique Ardena Temps plein

    **About us** **_ 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, manufacturing,...

  • Group Leader Chromatografie

    il y a 2 semaines

    Gent, Flandre, Belgique Anacura Temps plein

    anacura, een expertisecentrum in de gezondheidszorg met meer dan 250 werknemers én familiebedrijf gericht op groei, omvat drie onafhankelijke laboratoria: Labo Nuytinck, actief in medische analyses, en AnaBioTec en OHMX.bio, beide actief in geneesmiddelenontwikkeling. De laboratoria voeren hun belangrijkste activiteiten uit in een state-of-the-art gebouw in...

  • Lead Supply Chain, Lead Software Engineer

    il y a 2 semaines

    Gent, Flandre, Belgique Colruyt NV (Colruyt Group) Temps plein

    Over Colruyt Group Meer dan 33.000 mensen die samen dingen in beweging zetten. Als grote, duurzame Belgische retailer willen we écht iets betekenen voor onze medewerkers, klanten en partners. Reken maar dat we trots zijn op wat we vandaag doen We zoeken voortdurend naar opportuniteiten en duurzame samenwerkingen. Altijd toekomstgericht en vanuit de behoefte...

  • Group Maintenance Lead

    il y a 6 jours

    Gent, Flandre, Belgique Bakker & Partners Temps plein

    Ben jij een expert in maintenance en klaar om een sleutelrol te spelen in de verdere professionalisering van onderhoudsprocessen? Voor onze klant, Vandemoortele, zijn we op zoek naar een Maintenance Lead Europe. Vandemoortele is een internationaal voedingsbedrijf met Belgisch HQ (Gent), en Europees marktleider in 2 productgroepen: plant based food...

  • Group Maintenance Lead

    il y a 11 heures

    Gent, Flandre, Belgique Bakker & Partners Temps plein

    Ben jij een expert in maintenance en klaar om een sleutelrol te spelen in de verdere professionalisering van onderhoudsprocessen? Voor onze klant, Vandemoortele, zijn we op zoek naar een Maintenance Lead Europe. Vandemoortele is een internationaal voedingsbedrijf met Belgisch HQ (Gent), en Europees marktleider in 2 productgroepen: plant based food solutions...

  • Group Maintenance Lead

    il y a 15 heures

    Gent, Flandre, Belgique Bakker & Partners Temps plein

    Ben jij een expert in maintenance en klaar om een sleutelrol te spelen in de verdere professionalisering van onderhoudsprocessen? Voor onze klant, Vandemoortele, zijn we op zoek naar een Maintenance Lead Europe.Vandemoortele is een internationaal voedingsbedrijf met Belgisch HQ (Gent), en Europees marktleider in 2 productgroepen: plant based food solutions...