Your tasks

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

Our expectations

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

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)

Benefits

Fresenius Kabi Austria

Mag. Celina Gößler, MA

Hafnerstraße 36

8055 Graz

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

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