Senior Manager / Senior Scientist Physicochemical CMC Development

  • Fresenius Kabi
  • Eysins, VD, Switzerland
  • 13/05/2020
Full time Data Science Data Analytics Big Data Statistics

Job Description

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.

Your assignments

  • Provide guidance across biosimilar projects on scientific and quality strategy applicable to analytics
  • Oversee CQA assessment and establishment of analytical similarity corridor (Quality Target Product Profile) using state of the art analytical assays
  • Interpret complex physicochemical data and assess their relevance at the functional level
  • Develop with scientists within Fresenius-Kabi Analytical Team and/or CROs stage-adapted analytical toolbox for manufacturing clone selection, process development, demonstration of analytical similarity at large scale and assessment of comparability.
  • Create and maintain detailed, ambitious yet realistic analytical testing plans ensuring rigorous and timely decision making that maintains rapid project progression
  • Manage direct/indirect interaction with Fresenius-Kabi Analytical Teams and external CROs/CMOs respectively, including setting expectations and monitoring progress
  • Prepare statistical analysis plans and similarity assessments with CMC Statistics
  • Work with project managers to review submissions including Briefing Book, IND, IMPD etc. prior to regulatory consultations
  • Understand project strategy and highlight risks and issues, propose mitigation
  • Represent Fresenius-Kabi SwissBioSim at regulatory authority meetings and at internal review committees
  • Build and maintain scientific excellence in analytical research
  • Remain abreast of new developments in the Biosimilar field, and contribute to building business insight and knowledge within the Biosimilars team

Your profile

Education & Languages

  • Advanced scientific degree: PhD or equivalent with degree in biochemistry, bioanalytics and post grad training in respective fields
  • Fluency in English essential, both oral and written; additional languages (German or French) are an asset

Professional skills and Experience

  • Minimum of 10 years experience in R&D in biopharma/biotech industry
  • Specific experience of either of the following will be considered an advantage:
    • streamlining phase specific method development and validation (including method transfer) utilizing QbD and DoE principles
    • Significant exposure to biotech manufacturing operations and related analytics with responsibility for establishing pharmacopeial compliant DS and DP analytical control strategies
  • Demonstrated successful track record in analytical sciences of biologics, preferably in the field of biosimilars
  • Proven experience in regulatory consultations for biosimilar products and/or New Biological Entities in the EU/US
  • Demonstrated success operating in a global matrix organization with the full breadth of functions contributing to drug development

Personal skills & competences

  • Excellent analytical and strategic skills
  • Leadership competencies (proactive problem solving, influencing and decision making skills)
  • Ability to work accurately with attention to detail, motivated and focused on delivery to product objectives to challenging timelines
  • Excellent communication skills, both oral and written
  • Strong interpersonal, networking and relationship skills required, including team work and listening skills

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 290.000 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.