Your tasks
* Provide analytical expertise and know-how in the field of mAbs/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 mAbs/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)
We are caring for our employees
* Reliable employer
* Strong global growth
* International career opportunities
* Comprehensive education and training
* Home office
* Job ticket
* Active health promotion
* Free parking space
* Bike leasing
* Canteen
* Joint company events
Fresenius Kabi Austria
Frau Mag. Celina Gößler, MA
Hafnerstraße 36
8055 Graz
www.fresenius-kabi.at #J-18808-Ljbffr