Director, Upstream Process Development (m/f/d)

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.

Main Tasks

  • 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.

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: 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
  • 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
  • Karrierelevel:
  • Berufserfahrene
  • Einsatzbereich:
  • Sonstige
  • Arbeitsverhältnis:
  • Unbefristet / Vollzeit
  • Unternehmensbereich:
  • Fresenius Kabi
  • Standort:
  • International / Eysins
  • Bewerbungsfrist:
  • none - we look forward to your application
Svenja Reith
Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH
Ref. number: 44837

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 300.000 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.

Director, Upstream Process Development (m/f/d)

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

Main Tasks

  • 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.

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: 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
  • 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

Ihr Kontakt

Svenja Reith
Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH
Ref. number: 44837

Karrierelevel
Berufserfahrene
Einsatzbereich
Sonstige
Arbeitsverhältnis
Unbefristet / Vollzeit
Unternehmensbereich
Fresenius Kabi
Standort
International / Eysins
Bewerbungsfrist
none - we look forward to your application

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 300.000 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.

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