Senior Manager / Senior Scientist Upstream Process Development (Non Lab) (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.

  • 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
  • Strategically define the technical corridor for analytical similarity to be achieved when developing biosimilar products
  • Review and approve external protocols / reports and other documents
  • Assume a leading role in the planning and execution of USP tech transfer activities for handover and scale up of projects to external GMP manufacturing sites
  • 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
  • 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
  • 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
  • Represent Upstream Process Development at cross functional meetings
  • Coach, mentor and provide technical guidance to scientists and technicians

EDUCATION & LANGUAGES

  • Masters in Science or Engineering, or BSc with added experience
  • Fluency in English essential, French and/or German would be an asset

PROFESSIONAL SKILLS & EXPERIENCE

  • Minimum 5 years’ experience in Pharma/Biotech/Biosimilars Industry with demonstrated track record in Upstream processing for biologics (specifically mammalian cell culture)
  • Strong technical and scientific expertise across the Upstream development spectrum including process development, scale up, tech transfer, process characterization and large scale manufacturing
  • Experience in evaluation and implementation of new technologies are desirable but not essential

 PERSONAL SKILLS & COMPETENCIES

  • Technical leadership and influencing skills
  • 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 and flexibility to switch between projects if necessary
  • Entrepreneurial spirit and action / result driven
  • Cultivates innovation
  • Willingness to travel 25% of time
  • Karrierelevel:
  • Berufserfahrene
  • Einsatzbereich:
  • Forschung
  • 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: 38640

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.

Senior Manager / Senior Scientist Upstream Process Development (Non Lab) (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

  • 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
  • Strategically define the technical corridor for analytical similarity to be achieved when developing biosimilar products
  • Review and approve external protocols / reports and other documents
  • Assume a leading role in the planning and execution of USP tech transfer activities for handover and scale up of projects to external GMP manufacturing sites
  • 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
  • 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
  • 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
  • Represent Upstream Process Development at cross functional meetings
  • Coach, mentor and provide technical guidance to scientists and technicians

Your profile

EDUCATION & LANGUAGES

  • Masters in Science or Engineering, or BSc with added experience
  • Fluency in English essential, French and/or German would be an asset

PROFESSIONAL SKILLS & EXPERIENCE

  • Minimum 5 years’ experience in Pharma/Biotech/Biosimilars Industry with demonstrated track record in Upstream processing for biologics (specifically mammalian cell culture)
  • Strong technical and scientific expertise across the Upstream development spectrum including process development, scale up, tech transfer, process characterization and large scale manufacturing
  • Experience in evaluation and implementation of new technologies are desirable but not essential

 PERSONAL SKILLS & COMPETENCIES

  • Technical leadership and influencing skills
  • 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 and flexibility to switch between projects if necessary
  • Entrepreneurial spirit and action / result driven
  • Cultivates innovation
  • Willingness to travel 25% of time

Ihr Kontakt

Svenja Reith
Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH
Ref. number: 38640

Karrierelevel
Berufserfahrene
Einsatzbereich
Forschung
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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