Director, Upstream Process Development (m/f/d), Eysins
Fresenius Kabi Deutschland GmbH
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.
- Accountable for the upstream process development for biosimilars products
- Strategically define the technical corridor for biosimilarity to be achieved when developing biosimilar products
- Key member of the Biosimilars development team responsible for the upstream technical aspects of Biosimilars development e.g., upstream process development, process characterization, and validation of the upstream process and submission of CMC documents
- Provide technical and scientific oversight of licensed upstream processes to ensure consistency of DS/DP
- Management / oversight of USP laboratory in located in the Eysins Research and Development Centre
- Strategically define the technical corridor for analytical similarity to be achieved when developing biosimilar products
- Oversee and guide insourced (USP laboratory) and outsourced (CDO, CMO) upstream activities around the technical development of a Biosimilar; including, upstream process development and generation of drug product, clinical trial supply, process characterization and validation and submission of CMC documents
- Define technical development that follows the principles of Quality by Design (QbD) and specify activities, timelines, milestones and costs in collaboration with Global Manufacturing and 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 Development team
- Provide scientific and technical operational guidance for the upstream process development activities to the Biosimilars Development Teams and the Biosimilar Leadership Team
- Provide technical and scientific oversight of licensed upstream processes to ensure consistency of supply
- 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 Biosimilars development team to ensure effective on-boarding of new compounds
- Prepare and review (when appropriate) the CMC section of the regulatory dossier
- Serve as the technical operational upstream expert for regulatory consultations/interactions; including briefing book and dossier creation and question response
- Coach and develop USP laboratory staff by providing an environment that encourages personal and professional growth.
- Manage and ensure the setting of realistic personal development goals for USP laboratory staff and provide regularly scheduled feedback throughout the year.
- Ensure USP laboratory staff receive appropriate knowledge, skill development, and growth opportunities.
- Phd or BSc in relevant scientific / technical discipline and extensive experience with demonstrated track record in a biopharm/biotech company, or equivalent organisation
- Fluency in English, French would be an asset
- Experience: minimum 16 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
- 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