Director Downstream Process 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

• Strategically define the technical corridor for analytical similarity to be achieved when developing biosimilar products
• Oversee and guide insourced (DSP laboratory) and outsourced (CDO, CMO) downstream activities around the technical development of a Biosimilar; including, downstream process development and generation of drug substance, technology transfer, clinical trial manufacturing, process characterization and validation, submission of CMC documents and Life Cycle Management activities for licensed products
• Define technical development that follows the principles of Quality by Design (QbD) and specify activities, timelines, milestones and costs in collaboration with other functions (e.g. Supply)
• Drive issue resolution in order to achieve Biosimilarity within the pre-defined analytical similarity corridor
• Review results and interpretation of the package developed to demonstrate in vitro analytical similarity and achievement of the biosimilar corridor and make recommendation on the way forward with the Biosimilar Product Teams
• Provide scientific and technical operational guidance for the downstream process development activities to the Biosimilars Product Teams and the Biosimilar Leadership Teams
• Provide technical and scientific oversight of licensed products
• As required, support Business Development and Alliance Management by providing technical operations input into the assessment of candidate in-licensing products, and ensuring collaboration with partners
• Works with the appropriate teams to ensure effective on-boarding of new compounds
• Prepare and review (when appropriate) the CMC section of the regulatory dossier
• Serve as a technical/operational downstream expert for regulatory consultations/interactions; including briefing book and dossier creation and question response
• Coach and develop the DSP team by providing an environment that encourages personal and professional growth
• Manage and ensure the setting of realistic personal development goals for the DSP team and provide regularly scheduled feedback throughout the year
• Ensure the DSP team receive appropriate knowledge, skill development, and growth opportunities

Your profile

Education:

• Phd or BSc in relevant scientific / technical discipline and extensive experience with demonstrated track record in a biopharm/biotech company, or equivalent organisation

Languages:

• Fluency in English, French would be an asset

Work experience:

• Experience: >10 years in either academic/pharmaceutical/biotech company
• Previous experience working with biosimilars would be an advantage

Job Specific Competencies & Skills:

• Strong leadership and influencing skills
• Able to deal with uncertainty and work outside of scientific comfort zone.
• Proven ability to lead major and complex programs in area of scientific expertise.
• Ability to critically evaluate scientific data obtained at different stages of development
• Innovative
• Strong analytical skills to drive teams to deliver
• Ability to work on multiple projects concurrently
• Flexibility to switch between projects if necessary
• Entrepreneurial spirit and action/results driven