Analytical Services Group Leader

hace 4 semanas

Bilbao, España Ardena A tiempo completo

**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, logistics and bioanalytical services.

Ardena is a rapidly growing international orientated organization with a dedicated team of over 500 professionals operating from 7 sites in Belgium (Gent), The Netherlands (Amsterdam, Oss, Assen), Spain (Pamplona), Sweden (Sodertalje), and Latvia (Riga). Ardena has an open and transparent culture: team-spirit, an open mindset and ownership are important values in our company.

We are a dynamic drug developer offering exciting career opportunities to skilled and motivated people who want to work in a fast-growing market within the global pharmaceutical industry. Do you want to work in a challenging contract research and development environment, where experts come together to develop innovative drugs for unmet medical needs? Do you want to further develop Ardena and grow with us by becoming our next colleague? Then we might have the right opportunity for you.

For the Ardena Pamplona site, we are looking for an **ANALYTICAL SCIENTIST GROUP LEADER**

**WHAT YOU WILL WORK ON**

**YOUR KEY ROL**

Ardena Pamplona guides a worldwide portfolio of customers through the processes of formulation and analytical development, and the manufacturing and labeling of early and late phase 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 finished products, on incoming raw materials and on the finished clinical materials.

As Group Leader Analytical development, you act as technical expert with respect to analytical method development and GMP QC analysis. You are the first point of contact for all analytical challenges within the company.

**YOUR KEY RESPONSIBILITIES**

You are the technical expert in analytical method development and GMP quality control analysis:

- You translate customer project objectives into high quality analytical methods.
- You will be the analytical expert in meetings with your project team.
- You will function as the analytical problem solver on your team.
- You are responsible for the implementation of new analytical techniques in the laboratory.
- You will be in charge of monitoring the work of your team to ensure the achievement of objectives in time and effort.
- You are responsible for support of analytical scientists (associates) performing analytical development and GMP activities (method development, method installation, sample analysis, method validation, QC release testing, GMP stability studies).
- You will be the reviewer of the reports written by your team.
- Reporting to the Analytical Services Director.

**YOUR PROFILE LOOKS LIKE/ RESEMBLES**
- You have a PhD with scientific orientation (Pharmaceutical Sciences, Bioscience-Engineering, Biotechnology, Biochemistry,) or equivalent by experience.
- You have profound experience in development of chromatographic analytical methods, Reversed Phase chromatography and Ion Chromatography, SDS-PAGE, electrophoresis, ELISA, bioburden, sterility, endotoxins and spectroscopic techniques such as UV-Vis, FTIR. You have applied these techniques.
- Experience in CMC method development for large molecules is a plus
- Experience in a GMP environment is a plus.
- You are able to run development projects independently and to keep an eye on budget and timelines.
- You are able to motivate the scientists of the project team.
- You have a strong interest in drug research and development and the associated analytical development.
- You are familiar with MS Office (knowledge of Empower is an asset).
- You have strong analytical and 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).

**WHAT WE OFFER**
- An attractive and tailor-made compensation package that includes extra-legal benefits such as:

- Flexible working hours.
- Summer schedule.
- 27 vacation days per year
- Possibility to develop your skills in a fast-growing company with an international client portfolio.
- A dynamic working environment

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