Scientist - Analytical Chemistry (m/f/d), 100%

• Plan, interpret and report results of scientific experiments for timely supply of drug substances (DS) and drug products (DP).
• Write & review analytical documents (e.g Analytical methods, Specifications, Validation reports, Stability reports, Batch records for stability and release testing) and align the corresponding activities within a global project team.
• Drive method development for peptide drug substances and RLT Drug product.
• Manage interactions with internal and external stakeholders, including outsourced activities to CROs by providing scientific and technical guidance whenever necessary.
• Proactively identify scientific, technological and GMP challenges, propose creative solutions and communicate key issues to the Analytical Project Leader or respective technical project team.
• Work according to appropriate SOPs, GMP, Quality Directives, Health and Safety guidelines.
• Provide valuable input to the analytical CMC documents and support regulatory submissions.
• Drive, lead, and manage analytical activities including impurity profiling related to the analytical development of RLTs compounds (e. g. method development, validation, stability, and release testing).

• PhD in analytical chemistry or equivalent
• At least 5 years experience in the pharmaceutical industry with a track record in GMP activities for development or marketed products.
• Profound expertise in documentation writing (Stability Report, Validation, IND IMPD modules etc)
• Broad scientific knowledge in chemistry, pharmaceutical or analytical sciences, ability to perform in a highly dynamic environment.
• Advanced knowledge of laboratory and/or technical tools (e.g. HPLC, LC-MS, Quality management systems, statistical evaluation tools ...)
• Good knowledge of commonly used software and computer tools.
• Excellent scientific/technical writing skills.
• Languages: Fluent in English, German as a plus

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