Your tasks

• Provide analytical expertise and know how in the field of m Abs/protein analytics to deliver industry leading analytical packages in support of Fresenius Kabi Biosimilar Product development of the required standard for adherence to Global Health Authorities (in particular US and EU) requirements
• Collaborate with CMC Development teams, Regulatory Affairs and Quality functions to coordinate and deliver analytical packages against the project objectives
• Work with subject matter experts to write and review analytical relevant sections of Health Authority submissions including BLA and MAA and post-approval variations
• Drive best practice to ensure efficient and timely response to regulatory questions from within Analytical Development
• Liaise with functional heads and Regulatory CMC to develop a portfolio of topic specific templates based on HA guidance documents and / or standard HA information request answers
• Represent physchem analytics at Life Cycle Activities Committee
• Manage direct/indirect interaction with Fresenius-Kabi Analytical Teams

Our expectations

• Advanced degree in biochemistry, bioanalytics and post grad training in respective fields
• Minimum 7 years experience in R&D in biopharma/biotech industry specializing in m Abs/protein analytics
• Proven ability to rapidly understand experimental procedures, data, and concepts related to analytical development of biotherapeutics
• Sound knowledge in GLP/GMP, ability to interpret guidelines and to implement compliant analytical packages in highly regulated markets, Familiarity with BLA/MAA filing and ICH guidelines required
• Proven experience representing analytical development in regulatory consultations for biosimilar products (preferably) and/or New Biological Entities in the EU/US
• Significant exposure to and related analytics from Phase iii development to licensed Biopharmaceuticals including product life cycle management and product maintenance biotech manufacturing operations
• Fluency in English essential, both oral and written; additional languages (German or French) are an asset

We offer

• International challenges in a dynamic corporate environment
• Corporate social events
• Attractive performance-related salary package (annual gross salary starting at € 65.000,-, overpayment depending on occupational skills and experience)