Senior Manager / Senior Scientist Physicochemical CMC Development (m/f/d), Eysins

Fresenius Kabi ist ein weltweit tätiges Gesundheitsunternehmen, das Medikamente und Medizinprodukte zur Infusion, Transfusion und klinischen Ernährung anbietet. Unsere Produkte und Dienstleistungen werden in der Therapie und Versorgung von kritisch und chronisch kranken Patienten eingesetzt.

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
• Ensure that biosimilar “mindset” and specific requirements are communicated and adhered to by the dedicated internal and external resources
• 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
• Understand Fresenius Kabi’s corporate quality standards and ensure they are adhered to in the area of Biosimilars

Your profile

Education & Languages:

• Advanced scientific degree: Degree in biochemistry or similar, PhD or equivalent post-graduate training with analytics in respective fields
• Fluency in English essential, both oral and written to professional standard; additional languages (German or French) are an asset

Professional skills and Experience:

• Minimum of 7 years experience in R&D in biopharma/biotech industry
• Demonstrated successful track record in analytical sciences of biologics, preferably in the field of biosimilars but essential to have knowledge of antibody or biotherapeutic protein drug development
• Hands on experience or demonstrated know-how of protein characterisation
• 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
• Proven experience in support of 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