Lead Analytical Expert for Biopharma Development
vor 2 Wochen
We are seeking a highly skilled Lead Analytical Expert to join our team at Fresenius Kabi Austria GmbH.
About UsFresenius Kabi Austria, a subsidiary of Fresenius Kabi AG, is a leading manufacturer of infusion therapy and clinical nutrition products. As a top enterprise in the region, we care for our employees with a reliable work environment, strong global growth, international career opportunities, comprehensive training, active health promotion, free parking, and company events.
Job Details- Location: Graz, Austria
- Full-time position
- Unrestricted job type
- Provide analytical expertise in mAb/protein analytics to deliver industry-leading analytical packages for biosimilar product development.
- Collaborate with CMC Development teams, Regulatory Affairs, and Quality functions to coordinate and deliver analytical packages.
- Work with subject matter experts to write and review analytical sections of Health Authority submissions.
- Drive best practices to ensure efficient and timely response to regulatory questions.
- Liaise with functional heads to develop templates based on HA guidance documents.
- Represent physchem analytics at Life Cycle Activities Committee.
- Advanced degree in biochemistry and post-grad training in respective fields.
- Minimum 7 years of experience in R&D in biopharma/biotech industry specializing in mAbs/protein analytics.
- Ability to rapidly understand experimental procedures, data, and concepts related to analytical development.
- Familiarity with BLA/MAA filing and ICH guidelines.
- Proven experience representing analytical development in regulatory consultations.
- Fluency in English, both oral and written; additional languages (German or French) are an asset.
- International challenges in a dynamic corporate environment.
- Corporate social events.
- An attractive performance-related salary package with an annual gross salary starting at EUR 65,000,-.
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