Responsibilities:
1. Plan, interpret and report results of scientific experiments for timely supply of drug substances (DS) and drug products (DP).
2. 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.
3. Manage interactions with internal and external stakeholders, including outsourced activities to CROs by providing scientific and technical guidance whenever necessary.
4. Proactively identify scientific, technological and GMP challenges, propose creative solutions and communicate key issues to the Analytical Project Leader or respective technical project team.
5. Work according to appropriate SOPs, GMP, Quality Directives, Health and Safety & internal Company guidelines.
6. Provide valuable input to the analytical CMC documents and support regulatory submissions.
7. 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).
8. Provide scientific guidance to the cross-functional and global project teams and thereby scientifically drive our exciting RLT portfolio.
9. Display a collaborative and inspired attitude within project teams and our stakeholders and partners.
Qualifications:
1. Higher University Degree in Analytical Chemistry or related field.
2. Multiple experience in the pharmaceutical industry with a track record in GMP activities for development or marketed products.
3. Profound expertise in analytical raw data documentation, documentation writing (Stability Report, Validation, etc.).
4. Broad scientific knowledge in chemistry, pharmaceutical or analytical sciences, ability to perform in a highly dynamic environment.
5. Advanced knowledge of laboratory and/or technical tools (e.g., HPLC, LC-MS, Quality management systems, statistical evaluation tools).
6. Good scientific/technical writing skills.
7. Eager to develop new methods and assess new analytical techniques.
8. Proven leadership in guiding and mentoring colleagues, coming with excellent communication and role model skills.
9. Strong coordination skills, quality focus, collaborative spirit, self-driven attitude, high level of learning agility.
10. Fluent in English.
Company Overview:
International Environment within a renowned Pharmaceutical Company.
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