With our corporate philosophy of “caring for life”, we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face.
In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients.
- Responsible for CMC Data Management and for statistical support of activities conducted and supervised by RDMS
- Develop and implement an approach to CMC data management and integrate CMC data analysis across the RDMS organization
- Strengthen and build cross-organizational partnerships with Fresenius Kabi SwissBioSim laboratories, QA and IT groups to enable compliant CMC data management, integration, and analysis
- Strengthen core CMC statistical capability consisting of data management, programming, and reporting
- Support statistical approach to CMC data (e.g. similarity assessments, establishment of specifications, bridging of analytical methods, bridging of reference standards, method performance monitoring DoE-assisted developments, etc), both internally in process development and analytical development labs and externally at CRO/CMOs
- Ensure applicability and compliance of statistical tools used for data analysis to enable CMC development and submission of biosimilar applications in highly regulated markets
- Drive implementation, maintenance and upgrade of integrated CMC data analysis platforms to enable phase appropriate analyses
- Analyze internal operations and identify areas of improvement
- Advanced scientific degree: PhD with degree in statistics or MSc with post grad training in respective fields
- Minimum of 10 years+ experience in the biopharmaceutical industry
- Demonstrated successful track record in CMC statistical sciences of biologics. Command of statistical data analysis softwares e.g. SAS, JMP, etc
- Sound knowledge in GLP/GMP, ability to interpret guidelines and to implement compliant data analysis packages in highly regulated markets
- Proven experience in regulatory consultations for biosimilar products (preferably) and/or New Biological Entities in the EU/US
- Thorough understanding of some aspect of CMC operations; interest and demonstrated ability to learn across several disciplines (technical development manufacturing, analytics, tech transfer, quality, regulatory, etc)
- Demonstrated success operating in a global matrix organization with the full breadth of functions contributing to drug development and product supply chain
JOB SPECIFIC COMPETENCIES & SKILLS
- Excellent analytical and organizational skills
- Leadership competencies (proactive problem solving, influencing and decision making)
- Ability to work accurately with attention to detail, motivated and focused on delivery to product objectives
- Excellent communication skills, both oral and written
- Strong interpersonal, networking and relationship skills required, including team work and listening skills
- Fluency in English essential, both oral and written; additional languages (German or French) are an asset
Offen für Individualität und Vielfalt
Fresenius begrüßt Bewerbungen aller Menschen, unabhängig von Geschlecht, Alter, Herkunft, Nationalität, Religion, Behinderung, sexueller Identität und Orientierung oder sonstigen Merkmalen.
Sämtliche Personenbezeichnungen in dieser Stellenausschreibung gelten für alle Geschlechter gleichermaßen (männlich, weiblich, divers).
Karriere mit Sinn
Mehr als 300.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmensbereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden