Fresenius Kabi Austria, with headquarters in Graz and a further production site in Linz, is a subsidiary of Fresenius Kabi AG, a world leading manufacturer of infusion therapy and clinical nutrition products. Fresenius Kabi Austria has 1600 employees and ranges among the top enterprises of the region.

Shortfacts

Einsatzort
Graz

Ausmaß
Vollzeit

Eintrittsdatum
ab sofort

Anstellungsverhältnis
unbefristet

We are caring for our employees

• verlässlicher Arbeitgeber
• starkes globales Wachstum
• internationale Karrieremöglichkeiten
• umfassende Aus- und Weiterbildung
• aktive Gesundheitsförderung
• Gratis Parkplatz
• Kantine
• gemeinsame Firmenevents

Ihre Ansprechpartnerin:

Fresenius Kabi Austria GmbH
Mag. Celina Gößler, MA
Hafnerstraße 36
8055 Graz

Analytical Science & Technology (AS&T) Lead (m/f/d)

Ihr Aufgabengebiet

• Serve as the global technical owner for analytical methods for commercial biosimilar products (drug substance and drug product)
• Own and maintain analytical technical documentation (e.g., Analytical Control Strategy, Method Lifecycle Plans, Product Quality Risk Assessments, Product Technical Summary, Product Stability Plans)
• Ensure continued alignment between biosimilar analytical profile and reference product (biosimilarity and comparability)
• Lead global analytical performance reviews and ensure consistency across all manufacturing and testing sites, including CMOs and external laboratories. Proactively acts to reduce risks and improve performance
• Ensure ongoing method performance monitoring and trend analysis in accordance with continued process verification (CPV) and method lifecycle principles (ICH Q14/Q2)
• Drive technical investigations related to OOS/OOT, atypical results, assay variability, and method-related deviations
• Act as the primary analytical SME and global method owner for assigned external testing laboratories and CMOs
• Provide analytical technical content and review for regulatory submissions, variations, health authority responses, and post-approval changes
• Identify and execute studies to support product strategy and drive commercial, quality and delivery excellence

Wir erwarten

• M.S. or Ph.D. in Analytical Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related life science field
• 8+ years of experience in biologics analytical development, QC, or MS&T supporting commercial monoclonal antibody or biosimilar products
• Demonstrated experience with analytical method validation, transfer, and lifecycle management for commercial products
• Experience supporting regulatory submissions and health authority inspections
• Strong understanding of biologics characterization techniques (e.g., HPLC/UPLC, CE, mass spectrometry, bioassays, glycan analysis)
• Proficiency in statistical tools (e.g., JMP, Minitab, SIMCA, Spotfire) and data trending platforms
• Deep understanding of QbD principles, specification setting, and analytical control strategy development
• Familiarity with global regulatory expectations for biologics (FDA, EMA, PMDA, ICH Q2/Q6B/Q8-Q14)
• Strong analytical thinking and structured problem-solving capability
• Effective communicator capable of translating complex analytical topics for diverse audiences
• Excellent communication skills in English, both written and oral

Wir bieten

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

JETZT BEWERBEN