Senior Manager - Principal Scientist Nonclinical Pharmacology Biosimilars (NPB) (m/f/d)

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition.

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:

  • Provide nonclinical pharmacology expertise to biosimilar development and knowledge on biological mechanisms of action of drugs in support of similarity and extrapolation of indications;
  • Support CMC analytical quality and nonclinical pharmacology from characterization of the originator drug to commercial stage using literature and nonclinical pharmacology data relative to structure-function relationship;
  • Design and implement CMC pharmacodynamics and nonclinical pharmacology study plans for biosimilars development projects, highlight risks and issues, and propose mitigation plans;
  • Provide scientific expertise and take actions from CMC, Nonclinical Pharmacology and Biosimilars Development Teams;
  • Follow international guidelines, necessary quality standards and data management needs to fulfill regulatory requirements;
  • Ensure sourcing of necessary resources and establish contracts at CRO/CMOs;
  • Coordinate and guide experimental work done internally or externally;
  • Oversee assay development and qualification activities, provide support to technology transfer and assay validation for GMP compliant batch release, comparability and stability studies;
  • Analyze, evaluate and interpret results, establish report templates, review and approve study protocols and CMC and nonclinical pharmacology result reports;
  • Support cQA assessment and QTPP establishment for biosimilars products;
  • Assess the overall similarity of the products’ biological activity;
  • Assess product analytical quality data for its relevance at functional level for potential impact on safety and efficacy in the clinic, propose and implement justification packages in support of similarity and extrapolation of indications;
  • Write and review CMC and nonclinical pharmacology sections for dossiers delivered to regulatory agencies.

Other Tasks:

  • Perform literature search, provide scientific support for assay/study development and execution of nonclinical pharmacology plans;
  • Scout for CROs and research collaborations, prepare contracts (CDA, MTA, MSA), write RfP,revise work orders and SoWs seek approval and release invoices for work done by external collaborators;
  • Organize meetings, take minutes, distribute/execute and follow up on actions following cost and timelines;
  • Establish and follow internal processes and guidelines;
  • Ensure that biosimilar “mindset” and specific requirements are communicated and adhered to by the resources;
  • Represent nonclinical pharmacology at CMC and Biosimilars Development Teams, internal review and regulatory authority meetings;
  • Build and maintain scientific excellence in nonclinical pharmacology research;
  • Remain abreast of new developments in the Biosimilar field, and contribute to building business insight and knowledge within the Biosimilars team;
  • Assert senior role by mentoring/coaching junior colleagues and presenting topics at different levels in the organization.

Education:

  • Scientific degree (PhD) in Biology, Immunology, Pharmacology or related field

 Languages:

  • Fluency in English essential, both oral and written

Work experience:

  • Industry and academic experience with in vitro, ex vivo and in vivo non-clinical pharmacology, auto-immunity and inflammation, and oncology, with a strong knowledge on the different mechanisms of action of biologics and their indications;
  • Minimum 10 years of relevant experience in R&D of biopharma/biotech industry, including at mid-management level.

Job Specific Competencies & Skills:

  • Excellent knowledge and experience (hands on and team lead) with in vitro binding and potency bioassays using recombinant and primary cells (e.g. Fab and Fc activities, relevant technologies such as SPR, FACS, ELISA, cell-based etc.), and ex vivo/in vivo models to evaluate structure-function relationship, disease specific mechanisms of actions and PD biomarkers of biologics;
  • Expertise in pharmacodynamic data analysis (dose-response, , parallel-curve analysis, sensorgrams, descriptive and statistical assessments…) with relevant softwares;
  • Good understanding of regulatory requirements for biopharmaceutical drugs development (preferably Biosimilars) in US/EU;
  • A successful track record with CRO/CMO management for CMC and nonclinical pharmacology, ideally for biosimilars. Experience in potency method validation, technology transfer at CMO and (GMP) QC release;
  • Good background or understanding of CMC analytical development, process development and manufacturing of biologics in general;
  • Ability to work in a small team and broad scope, cross-functional and cross-cultural teams;
  • Able to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful manner; responsible of delivery of functional contribution as per agreed time, cost and quality;

Additional competencies and personal skills required for this role include the following:

  • Leadership competencies: Able to guide other partners effectively. Achieve organizational focus on key priorities; demonstrate good judgment and business maturity to make sound decisions. Create a culture of high performance, team orientation; accountability and commitment;
  • Collaboration skills: Able to work effectively in a team-based organization, listen well, collaborate cross-functionally, influence peers and superiors, and readily build alignment. Achieve agreement on key priorities. Able to influence strategic partners to maximize opportunities;
  • Results orientation: Able to establish clear expectations and focus resources on key priorities. Continually monitor performance; consistently deliver expected results. Flexible and responsive to change; creative problem-solving skills. Decisive and action-oriented;
  • Communication skills: Ability to simplify and convey complex concepts and strategies, orally and in writing. Chair meetings effectively and ensure discussions are advanced appropriately. Strong presentation and negotiating skills. Seek broad input and feedback; apply effective follow-up. Able to represent R&D externally.
  • 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: 39807

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 - Principal Scientist Nonclinical Pharmacology Biosimilars (NPB) (m/f/d)

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition.

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:

  • Provide nonclinical pharmacology expertise to biosimilar development and knowledge on biological mechanisms of action of drugs in support of similarity and extrapolation of indications;
  • Support CMC analytical quality and nonclinical pharmacology from characterization of the originator drug to commercial stage using literature and nonclinical pharmacology data relative to structure-function relationship;
  • Design and implement CMC pharmacodynamics and nonclinical pharmacology study plans for biosimilars development projects, highlight risks and issues, and propose mitigation plans;
  • Provide scientific expertise and take actions from CMC, Nonclinical Pharmacology and Biosimilars Development Teams;
  • Follow international guidelines, necessary quality standards and data management needs to fulfill regulatory requirements;
  • Ensure sourcing of necessary resources and establish contracts at CRO/CMOs;
  • Coordinate and guide experimental work done internally or externally;
  • Oversee assay development and qualification activities, provide support to technology transfer and assay validation for GMP compliant batch release, comparability and stability studies;
  • Analyze, evaluate and interpret results, establish report templates, review and approve study protocols and CMC and nonclinical pharmacology result reports;
  • Support cQA assessment and QTPP establishment for biosimilars products;
  • Assess the overall similarity of the products’ biological activity;
  • Assess product analytical quality data for its relevance at functional level for potential impact on safety and efficacy in the clinic, propose and implement justification packages in support of similarity and extrapolation of indications;
  • Write and review CMC and nonclinical pharmacology sections for dossiers delivered to regulatory agencies.

Other Tasks:

  • Perform literature search, provide scientific support for assay/study development and execution of nonclinical pharmacology plans;
  • Scout for CROs and research collaborations, prepare contracts (CDA, MTA, MSA), write RfP,revise work orders and SoWs seek approval and release invoices for work done by external collaborators;
  • Organize meetings, take minutes, distribute/execute and follow up on actions following cost and timelines;
  • Establish and follow internal processes and guidelines;
  • Ensure that biosimilar “mindset” and specific requirements are communicated and adhered to by the resources;
  • Represent nonclinical pharmacology at CMC and Biosimilars Development Teams, internal review and regulatory authority meetings;
  • Build and maintain scientific excellence in nonclinical pharmacology research;
  • Remain abreast of new developments in the Biosimilar field, and contribute to building business insight and knowledge within the Biosimilars team;
  • Assert senior role by mentoring/coaching junior colleagues and presenting topics at different levels in the organization.

Your profile

Education:

  • Scientific degree (PhD) in Biology, Immunology, Pharmacology or related field

 Languages:

  • Fluency in English essential, both oral and written

Work experience:

  • Industry and academic experience with in vitro, ex vivo and in vivo non-clinical pharmacology, auto-immunity and inflammation, and oncology, with a strong knowledge on the different mechanisms of action of biologics and their indications;
  • Minimum 10 years of relevant experience in R&D of biopharma/biotech industry, including at mid-management level.

Job Specific Competencies & Skills:

  • Excellent knowledge and experience (hands on and team lead) with in vitro binding and potency bioassays using recombinant and primary cells (e.g. Fab and Fc activities, relevant technologies such as SPR, FACS, ELISA, cell-based etc.), and ex vivo/in vivo models to evaluate structure-function relationship, disease specific mechanisms of actions and PD biomarkers of biologics;
  • Expertise in pharmacodynamic data analysis (dose-response, , parallel-curve analysis, sensorgrams, descriptive and statistical assessments…) with relevant softwares;
  • Good understanding of regulatory requirements for biopharmaceutical drugs development (preferably Biosimilars) in US/EU;
  • A successful track record with CRO/CMO management for CMC and nonclinical pharmacology, ideally for biosimilars. Experience in potency method validation, technology transfer at CMO and (GMP) QC release;
  • Good background or understanding of CMC analytical development, process development and manufacturing of biologics in general;
  • Ability to work in a small team and broad scope, cross-functional and cross-cultural teams;
  • Able to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful manner; responsible of delivery of functional contribution as per agreed time, cost and quality;

Additional competencies and personal skills required for this role include the following:

  • Leadership competencies: Able to guide other partners effectively. Achieve organizational focus on key priorities; demonstrate good judgment and business maturity to make sound decisions. Create a culture of high performance, team orientation; accountability and commitment;
  • Collaboration skills: Able to work effectively in a team-based organization, listen well, collaborate cross-functionally, influence peers and superiors, and readily build alignment. Achieve agreement on key priorities. Able to influence strategic partners to maximize opportunities;
  • Results orientation: Able to establish clear expectations and focus resources on key priorities. Continually monitor performance; consistently deliver expected results. Flexible and responsive to change; creative problem-solving skills. Decisive and action-oriented;
  • Communication skills: Ability to simplify and convey complex concepts and strategies, orally and in writing. Chair meetings effectively and ensure discussions are advanced appropriately. Strong presentation and negotiating skills. Seek broad input and feedback; apply effective follow-up. Able to represent R&D externally.

Ihr Kontakt

Svenja Reith
Fresenius Kabi SwissBioSim GmbH
Fresenius Kabi SwissBioSim GmbH
Ref. number: 39807

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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