Experienced Scientist Analytical Development

Locatie: Leiden, South Holland, Netherlands
Salaris: competitive
Sectoren: Life Sciences
Soort functie: Freelance
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Experienced Scientist Analytical Development

Department/Project:

The Analytical Development (AD) department is responsible for development and implementation of methods required for release and characterization of vaccine products from early to late product development stages. Within AD, the Analytical Assays (AA) group focuses on development of HPLC, electrophoretic, spectrophotometric, CE, DLS, MS and other physicochemical methods for the analysis of a wide range of virus-based products.

Job Description:

We are looking for an experienced scientist who enjoys working in a multidisciplinary team. Your main responsibilities will be to lead the development and validation of analytical methods in different clinical development phases, provide scientific input into IND/IMPD/MAA/BLA sections, represent the AA team within the organization, and implement new separation technologies. Connecting with experts and effectively leveraging knowledge of others will be critical to meeting project and budget expectations. In addition, with your expertise you will provide analytical input into vaccine projects, drive continuous improvements, as well as coach junior members of the team.

Minimum Qualifications:

a) PhD or equivalent experience in a relevant discipline such as analytical or physical chemistry, biochemistry or bio-pharmaceutical sciences.
b) At least 5 years experience with
1) analytical method development, qualification, validation and transfer for vaccine or other biological products,
2) regulatory filing at different clinical development phases up to and including phase III and registration, and
3) quality systems such as GMP.
c) Experience in techniques such as LC, CE, FFF-MALS, DLS, and AUC
d) Good network in the pharmaceutical product development industry for method development and product characterization.

Competences:

The candidate fit for the job should have demonstrated people management and coaching skills, be result-oriented, pragmatic and able to cope with changes. Good communication and documentation skills and an attitude focused on team performance are needed for this position.

For more information, and to apply, please send me your recent CV + Cover letter to: j.vanbaalen(@)progressive-nl.com

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