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Director Analytical 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 **Drug Product Development and Manufacturing (DDM)**based in Ghent (Belgium), we are looking for a
**DIRECTOR ANALYTICAL DEVELOPMENT**
**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 analytical laboratory plays a key role in the development and validation of analytical methods to characterize drugs and to perform quality control testing on incoming raw materials and on the finished clinical materials. Historically, Ardena worked mainly on **small molecules**. However, with the expansion of our portfolio with aseptic fill and finish (F&F) capabilities, we are also **entering** the **large molecule and oligonucleotide market**.
As Director Analytical development, you have the full responsibility for the direction of all assigned analytical and quality control activities within the department. You also lead and coach a team of about 30 people and you forecast and plan the available resources in the most optimal way.
**YOUR KEY RESPONSIBILITIES**
- You are directing all analytical method development and GMP QC analysis for our large and small molecules projects.
- You plan the activities and organizes the department in such a way that you meet or exceed productivity, quality and capacity objectives.
- You are responsible for the implementation of new analytical techniques or software in the lab in close collaboration with the validation and maintenance department. Implementing these techniques, you aim for an expansion of the service portfolio or for process improvement and efficiency increase.
- You lead, assess, coach, and develop a team of Group Leaders and (Associate) Scientists. Therefore, you manage their performance; you ensure the team meets expectations and objectives.
- You guide the professional growth of team members by providing personal guidance and training relative to responsibilities.
- You interact with the other departments (formulation development, production, quality, project management office) to solve quality issues, to support in case of unexpected results or to define priorities. You translate the defined priorities to an action plan for your team.
- You provide critical technical feedback on client project proposals and propose a phase-appropriate set-up for analytics in line with the scope of the project.
- You are part of the local management team.
- You report to the Business Unit Director of the Drug Development and Manufacturing Business Unit.
**YOUR PROFILE**
- You have a PhD or a master’s degree with a scientific orientation (Pharmaceutical Sciences, Bioscience-Engineering, Biotechnology, Biochemistry,) with minimum 10+ years of related analytical development experience. Additionally, you have at least 2 years relevant managerial and leadership experience.
- You must have knowledge in CMC method development and relevant guidelines (ICH, EMA, WHO, FDA,...).
- You are quality oriented and have strong GMP knowledge.
- You are customer driven and run the extra mile to keep the project timelines and budgets on track.
- You show flexibility and you are open-minded and change oriented (always looking for ways to improve).
- You can deal with multiple projects and competing priorities.
- You have strong team building and collaboration skills with an ability to build consensus among both internal departments and customers.
- You are familiar with MS Office (knowledge of Empower is an asset).
**WHAT WE OFFER**
- A rapidly developing and growing international company with an at
