Senior Manager / Senior Scientist Downstream 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:

  • Oversee and guide outsourced (CDO, CMO) downstream activities around the technical development of a Biosimilar; including, downstream process development and manufacture of drug substance, clinical trial supply, process characterization and validation, Cost of Goods optimization, and submission of CMC documents
  • Assume a leading role in the planning and execution of DSP tech transfer activities for handover and scale up of projects to external GMP manufacturing sites
  • Review and approve external protocols / reports and other 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; design and guide process characterization and process validation support activities.
  • Provide support to the analytics team to define the technical corridor for analytical similarity to be achieved when developing biosimilar products
  • Drive issue resolution for Downstream process in order to achieve analytical similarity within the pre-defined analytical similarity corridor; drive and support downstream troubleshooting and root-cause investigation activities at the CMO during development, GMP, PPQ and commercial campaigns
  • Provide scientific and technical guidance for the downstream process development activities for the in-house development labs and to the Biosimilars Development Teams and the Biosimilar Leadership Team
  • Provide technical and scientific oversight of licensed downstream processes to ensure consistency of supply
  • Prepare and review the CMC section of the regulatory dossier
  • Serve as the technical operational downstream expert for regulatory consultations/interactions; including briefing book and dossier creation and question response
  • Represent Downstream Process Development at cross functional meetings
  • Build strong relationships and a collaborative network with cross functional teams

Qualification 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 7 years’ experience in Biotech/Biosimilars Industry with demonstrated track record in Downstream processing for biologics (specifically mammalian cell culture downstream)
  • Strong technical expertise across the Downstream development spectrum including process development, scale up, tech transfer, large scale manufacturing and process characterization
  • Experience in evaluation and implementation of new technologies are desirable but not essential

 PERSONAL SKILLS & COMPETENCIES

  • Technical leadership and influencing skills to drive teams to deliver
  • Strong analytical skills and ability to critically evaluate scientific data obtained at different stages of development
  • 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 up to 20% of the time based on business needs
  • 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: 42977

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 Downstream 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:

  • Oversee and guide outsourced (CDO, CMO) downstream activities around the technical development of a Biosimilar; including, downstream process development and manufacture of drug substance, clinical trial supply, process characterization and validation, Cost of Goods optimization, and submission of CMC documents
  • Assume a leading role in the planning and execution of DSP tech transfer activities for handover and scale up of projects to external GMP manufacturing sites
  • Review and approve external protocols / reports and other 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; design and guide process characterization and process validation support activities.
  • Provide support to the analytics team to define the technical corridor for analytical similarity to be achieved when developing biosimilar products
  • Drive issue resolution for Downstream process in order to achieve analytical similarity within the pre-defined analytical similarity corridor; drive and support downstream troubleshooting and root-cause investigation activities at the CMO during development, GMP, PPQ and commercial campaigns
  • Provide scientific and technical guidance for the downstream process development activities for the in-house development labs and to the Biosimilars Development Teams and the Biosimilar Leadership Team
  • Provide technical and scientific oversight of licensed downstream processes to ensure consistency of supply
  • Prepare and review the CMC section of the regulatory dossier
  • Serve as the technical operational downstream expert for regulatory consultations/interactions; including briefing book and dossier creation and question response
  • Represent Downstream Process Development at cross functional meetings
  • Build strong relationships and a collaborative network with cross functional teams

Your profile

Qualification 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 7 years’ experience in Biotech/Biosimilars Industry with demonstrated track record in Downstream processing for biologics (specifically mammalian cell culture downstream)
  • Strong technical expertise across the Downstream development spectrum including process development, scale up, tech transfer, large scale manufacturing and process characterization
  • Experience in evaluation and implementation of new technologies are desirable but not essential

 PERSONAL SKILLS & COMPETENCIES

  • Technical leadership and influencing skills to drive teams to deliver
  • Strong analytical skills and ability to critically evaluate scientific data obtained at different stages of development
  • 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 up to 20% of the time based on business needs

Ihr Kontakt

Svenja Reith
Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH
Ref. number: 42977

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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