Analytical Expert (m/f)

REFERENZNUMMER:

342223/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

R&D scientist