Director Downstream Process Development - Eysins, Schweiz - Fresenius Kabi

Beschreibung

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.

Fresenius Kabi SwissBiosim has also been certified as an Equal Pay Employer.
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 predefined 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
• Works with the appropriate teams to ensure effective onboarding 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

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

• Auf einen Blick

• Standort:
• InternationalEysins
• Karrierelevel:
• Berufserfahrene
• Arbeitsverhältnis:
• UnbefristetVollzeit
• Unternehmen:
• Fresenius Kabi
• Referenznummer:

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