Principal Scientist

Key responsibilities:

• Lead and coordinate pre-formulation, formulation and process development tasks and represent pharmaceutical development in the project team
• Accountable for managing all pharmaceutical development related activities of Drug Product development incl. pre-formulation, Quality by Design formulation and process development, technology transfers
• Design, plan, perform and documentation as well as statistical analysis and interpretation of scientific experiments to drive development of final drug product and manufacturing process for solid and liquid dosage forms applying QbD principles with special focus on rigorous DoE
• Communicate effectively across organizational interfaces i.e. project-/program management, line functions etc.
• Proactively identify scientific, technological and GMP issues, propose creative solutions and communicate key issues to the appropriate management level
• Responsible for high quality documentation for regulatory submissions and interact with authorities, act as a technical expert in audits, inspections etc.

Your profile:

• 3-5 years of hands-on industry experience in formulation, pre-formulation, de-formulation and manufacturing process development
• Proficient in using statistical tools like Minitab, Design Expert etc.
• Excellent understanding of regulatory expectations and requirements including EMA, US FDA, ANVISA, PMDA
• Expert understanding of Data Integrity, cGMP, ICH guidelines and regulatory requirements
• Experience working in interdisciplinary teams with excellent theoretical and scientific knowledge of product development
• Proven track record of creativity, problem solving and productivity
• Proficient scientific/technical writing skills
• Languages: Fluent in English (oral and written), basic German skills an advantage