Beschreibung
We are looking for an
Analytical Expert (m/f)
Reference: -en
Start: 07/17
Duration: 12 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Design, plan, perform, interpret and report results of scientific experiments for the preparation and timely delivery of drug substances (DS) and drug products (DP)
- Responsible for analytical methods development, validation, stability and release testing and transfer activities of drug substance and formulated drug product
- Contribute to the overall analytical project strategy
- Write analytical documents (e.g. analytical methods, validation reports, stability reports)
- Ensure GMP compliance for all GMP relevant analytical activities of assigned projects in alignment regulations and network decisions
- Author, reviewer and approver of GMP relevant documents (e.g. analytical methods, raw data, SOPs, qualification reports for analytical instruments etc.)
- Review analytical batch records according to SOPs
- Support defining the analytical strategy of development projects (proposes specifications, re-test dates, storage conditions, and/or batch release decision according to analytical results, SOPs, and guidelines)
- Identify scientific, technological and GMP issues and propose solutions to relevant persons in the analytical project team
- Demonstrate cost awareness in all assigned projects and/or networks
Your qualifications
- PhD or Master in analytical chemistry or equivalent
- Profound experience in the pharmaceutical industry, preferably in analytical development
- Strong scientific knowledge in analytical development
- Fluency in English (oral and in writing)
- GMP knowledge (work history in cGMP environment) is of advantage
Skills:
- R&D scientist