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

Fresenius Kabi Austria; Graz; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

Homeoffice

Jobticket

Canteen

Free parking space

Bikeleasing

Corporate events

Zusammenfassung

Fresenius Kabi Austria in Graz is seeking a senior professional to serve as the global technical owner for analytical methods for biosimilar products. You will own critical documentation, ensure biosimilarity with reference products, and lead global performance reviews across sites, including CMOs and external labs.

The role requires deep expertise in analytical methods, lifecycle management, and regulatory interactions.

Qualifikationen

• MS/PhD 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 (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.
• Excellent communication skills in English, both written and oral.

Aufgaben

• 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.

Kenntnisse

Analytical thinking

Communication

English fluency

Problem solving

Ausbildung

MS/PhD in Analytical Chemistry or related life sciences

Tools

JMP

Minitab

SIMCA

Spotfire

Jobbeschreibung

• 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
• 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

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

• Reliable employer
• Strong global growth
• International career opportunities
• Comprehensive education and training
• Homeoffice
• Jobticket
• Active health promotion
• Free parking space
• Bikeleasing
• Canteen
• Joint company events

Fresenius Kabi Austria

Mag. Celina Gößler, MA

Hafnerstraße 36

8055 Graz