Senior Manager Life Cycle Project Management (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.

  • Manage Life Cycle and Insourcing activities for the FKSBS Biosimilar portfolio:
    • Manage LCM and Insourcing meetings
    • Ensure visibility of plans and changes of all LCM and Insourcing activities
    • Ensure detailed timelines and budgets are established and respected through negotiation with project stakeholders.
    • Coordinate with functions leads (RDMS, Quality, Regulatory Affairs, IP, Sites functions) to ensure timely execution of work packages
    • Establish & manage LCM and insourcing documentation (work-package reports, minutes of internal and external meetings, risk assessments)
  • Act as point of contact for Insourcing & LCM activities
  • Support the organization in the setup of LCM activities with external partners (SoWs, budgets, SME review).
  • Support functions in defining the LCM and insourcing strategy and related stakeholder management
  • Manage LCM budget (actuals, accruals, forecast, short & long term planning):
    • work in close collaboration with the controller
    • Provide LCM and Insourcing teams with early warnings on possible budget variances. In case of major variations inform team according to established governance guidelines.
    • Challenge team members on their functional project activities to ensure efficient and cost conscientious development.
  • Create state-of-the-art project management tools for LCM and insourcing activities (budget, KPIs and resource mapping)
  • Other relevant activities as required

Qualification profile:

  • BSc, MSc, PhD or equivalent in biochemical engineering, biochemistry, biology, pharmacy or related discipline.
  • Minimum 7 years of relevant biologics R&D and/or CMC experience in a Pharma/Biotech industrial setting.
  • Experience in biosimilar development and/or commercialization is a plus
  • Strong project management skills and master state-of-the-art multi-projects & program management tools & techniques.
  • Competencies: excellent planning and organizational skills, excellent communication skills, customer orientation, problem analysis and solving, results-oriented, teamwork-oriented
  • Familiarity with current GMP guidelines
  • Some knowledge and/or exposure to regulatory requirements and submissions (IMPD/IND/BLA) and quality requirements from the industry (GMP; FDA; ICH)
  • Experience with managing and overseeing a budget
  • Practical experience or theoretical knowledge in some of these fields would be a strong asset: process development, analytics, technology transfer, process scale up, process validation, GMP manufacturing in the Biotech industry.
  • Fluent English is required; French is an asset
  • Karrierelevel:
  • Berufserfahrene
  • Einsatzbereich:
  • Projektmanagement
  • Arbeitsverhältnis:
  • Unbefristet / Teilzeit
  • 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: 43165

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 Life Cycle Project Management (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

  • Manage Life Cycle and Insourcing activities for the FKSBS Biosimilar portfolio:
    • Manage LCM and Insourcing meetings
    • Ensure visibility of plans and changes of all LCM and Insourcing activities
    • Ensure detailed timelines and budgets are established and respected through negotiation with project stakeholders.
    • Coordinate with functions leads (RDMS, Quality, Regulatory Affairs, IP, Sites functions) to ensure timely execution of work packages
    • Establish & manage LCM and insourcing documentation (work-package reports, minutes of internal and external meetings, risk assessments)
  • Act as point of contact for Insourcing & LCM activities
  • Support the organization in the setup of LCM activities with external partners (SoWs, budgets, SME review).
  • Support functions in defining the LCM and insourcing strategy and related stakeholder management
  • Manage LCM budget (actuals, accruals, forecast, short & long term planning):
    • work in close collaboration with the controller
    • Provide LCM and Insourcing teams with early warnings on possible budget variances. In case of major variations inform team according to established governance guidelines.
    • Challenge team members on their functional project activities to ensure efficient and cost conscientious development.
  • Create state-of-the-art project management tools for LCM and insourcing activities (budget, KPIs and resource mapping)
  • Other relevant activities as required

Your profile

Qualification profile:

  • BSc, MSc, PhD or equivalent in biochemical engineering, biochemistry, biology, pharmacy or related discipline.
  • Minimum 7 years of relevant biologics R&D and/or CMC experience in a Pharma/Biotech industrial setting.
  • Experience in biosimilar development and/or commercialization is a plus
  • Strong project management skills and master state-of-the-art multi-projects & program management tools & techniques.
  • Competencies: excellent planning and organizational skills, excellent communication skills, customer orientation, problem analysis and solving, results-oriented, teamwork-oriented
  • Familiarity with current GMP guidelines
  • Some knowledge and/or exposure to regulatory requirements and submissions (IMPD/IND/BLA) and quality requirements from the industry (GMP; FDA; ICH)
  • Experience with managing and overseeing a budget
  • Practical experience or theoretical knowledge in some of these fields would be a strong asset: process development, analytics, technology transfer, process scale up, process validation, GMP manufacturing in the Biotech industry.
  • Fluent English is required; French is an asset

Ihr Kontakt

Svenja Reith
Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH
Ref. number: 43165

Karrierelevel
Berufserfahrene
Einsatzbereich
Projektmanagement
Arbeitsverhältnis
Unbefristet / Teilzeit
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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