Your key responsibilities:
Your responsibilities include, but are not limited to:
You will lead and coordinate the analytical tasks and represent analytics in the project team of assigned projects.
You are accountable for managing all analytic related activities of Drug Product development incl. release and stability-testing, characterization of the API, method-development, -transfer and -validation, specification setting, know-how transfer etc.
You will need to communicate effectively across organizational interfaces i.e. project-/program-management; line functions etc.
You will proactively identify scientific, technological and GMP issues, propose creative solutions and communicate key issues to the appropriate management level.
You are responsible for high quality analytical registration documents for HA submissions and you will interact with authorities, acting as a technical expert in audits, inspections etc.
You are responsible for resource planning.
What you’ll bring to the role:
PhD with 3 years relevant experience in product development or MSc with 6 years relevant experience in product development or BSc or equivalent technical education with 12 years relevant experience in product development.
Previous experience in analytical areas in drug development in an industrial setting.
Proven leader with experience in managing multiple tasks.
Demonstrated excellent communication, presentation and management skills.
Excellent understanding of regulatory expectations and requirements.
Worked 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), skills in German are welcome.
Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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