Lead Analytical Expert for Biopharma Development

vor 2 Wochen


Graz, Steiermark, Österreich Fresenius Kabi Austria GmbH Vollzeit

We are seeking a highly skilled Lead Analytical Expert to join our team at Fresenius Kabi Austria GmbH.

About Us

Fresenius 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
Responsibilities
  1. Provide analytical expertise in mAb/protein analytics to deliver industry-leading analytical packages for biosimilar product development.
  2. Collaborate with CMC Development teams, Regulatory Affairs, and Quality functions to coordinate and deliver analytical packages.
  3. Work with subject matter experts to write and review analytical sections of Health Authority submissions.
  4. Drive best practices to ensure efficient and timely response to regulatory questions.
  5. Liaise with functional heads to develop templates based on HA guidance documents.
  6. Represent physchem analytics at Life Cycle Activities Committee.
Requirements
  • 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.
What We Offer
  • 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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