- Our company is a young and dynamic company, specialized in contract activities servicing the chemical, pharmaceutical and biotech industries.
- The core activities of our European facility consist of process research & development combined with integrated analytical development and solid state activities, scale- up and small scale manufacture in a GMP quality environment.
- For the Analytical Chemistry Department , we are currently looking for an Analyst II (m/f).
- The Analytical Chemistry department is responsible for analytical method development and –validation, testing of raw materials, In-Process Controls, Intermediates and Active Pharmaceutical Ingredients (APIs), and stability testing
- The Analytical Chemistry department is equipped with state-to-the art analytical techniques like GC (MS), (u)HPLC (MS-MS), ICP (MS), NMR, IC, wet chemistry, FT-IR.
- The Analyst develops analytical methods (appropriate for the clinical phase the project is running into) to support the development of process routes and to support demo batches and/or pilot plant campaigns.
- The development may start from scratch or based on a technical package delivered by the customer.
- Beside of method development the analyst performs all related tasks needed to set up an analytical method, as (but not limited to): creation of specification sheets, qualification of reference standards, forced degradation studies, analytical method validation, and the development of stability indicating methods for stability studies.
- Participate directly with external parties to address and resolve problems identified during the analytical-R&D.
- Assist with the compilation of reports (progress reports, GMP-documentation and so on).
- Finally the analyst is involved in testing of the project specific raw materials, in-process controls, intermediates and Active Pharmaceutical Ingredient.
- At least bachelor’s degree in the field of analytical chemistry, with a minimum of 3-5 years’ experience in a similar job.
- Experienced in analytical method development and analytical method validation.
- Experience in LC-MS and LC-prep is a pre.
Other preferred qualifications:
- Good organizational skills and high attention to detail.
- Strong understanding of cGMP and regulatory requirements as they relate to laboratory practices.
- Strong data handling skills and an understanding of the importance of data integrity.
- An ability to analyze qualitative and quantitative information to draw conclusions and make recommendations, based on clear scientific rationale.
- Excellent problem solving aptitude, communication and multi-tasking skills.