Senior Manager / Senior Scientist Physicochemical CMC Development (m/f/d)
Fresenius Kabi SwissBioSim GmbH
Eysins, Deutschland
vor 3 Tg.
source : 1a-stellenmarkt-ppc

About Fresenius / CAREER WITH A PURPOSE / Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition.

Our products and services are used to help care for critically and chronically ill patients.Senior Manager / Senior Scientist Physicochemical CMC 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.Fresenius Kabi SwissBiosim has also been certified as an Equal Pay Employer.
  • Your assignmentsProvide guidance across biosimilar projects on scientific and quality strategy applicable to analyticsOversee CQA assessment and establishment of analytical similarity corridor (Quality Target Product Profile) using state of the art analytical assays Interpret complex physicochemical data and assess their relevance at the functional levelDevelop with scientists within Fresenius

  • Kabi Analytical Team and / or CROs stage
  • adapted analytical toolbox for manufacturing clone selection, process development, demonstration of analytical similarity at large scale and assessment of comparabilityCreate and maintain detailed, ambitious yet realistic analytical testing plans ensuring rigorous and timely decision making that maintains rapid project progressionManage direct / indirect interaction with Fresenius
  • Kabi Analytical Teams and external CROs / CMOs respectively, including setting expectations and monitoring progressPrepare statistical analysis plans and similarity assessments with CMC StatisticsWork with project managers to review submissions including Briefing Book, IND, IMPD etc.
  • prior to regulatory consultationsUnderstand project strategy and highlight risks and issues, propose mitigationRepresent Fresenius

  • Kabi SwissBioSim at regulatory authority meetings and at internal review committeesEnsure that biosimilar mindset and specific requirements are communicated and adhered to by the dedicated internal and external resourcesBuild and maintain scientific excellence in analytical researchRemain abreast of new developments in the Biosimilar field, and contribute to building business insight and knowledge within the Biosimilars teamUnderstand Fresenius Kabis corporate quality standards and ensure they are adhered to in the area of BiosimilarsYour profileEducation & LanguagesAdvanced scientific degree : Degree in biochemistry or similar, PhD or equivalent post
  • graduate training with analytics in respective fieldsFluency in English essential, both oral and written to professional standard;
  • additional languages (German or French) are an assetProfessional skills and ExperienceMinimum of 7 years experience in R&D in biopharma / biotech industryDemonstrated successful track record in analytical sciences of biologics, preferably in the field of biosimilars but essential to have knowledge of antibody or biotherapeutic protein drug developmentHands on experience or demonstrated know

  • how of protein characterisationSpecific experience of either of the following will be considered an advantage : streamlining phase specific method development and validation (including method transfer) utilizing QbD and DoE principlesSignificant exposure to biotech manufacturing operations and related analytics with responsibility for establishing pharmacopeial compliant DS and DP analytical control strategiesProven experience in support of regulatory consultations for biosimilar products and / or New Biological Entities in the EU / USDemonstrated success operating in a global matrix organization with the full breadth of functions contributing to drug developmentPersonal skills & competencesExcellent analytical and strategic skillsLeadership competencies (proactive problem solving, influencing and decision making skills)Ability to work accurately with attention to detail, motivated and focused on delivery to product objectives to challenging timelinesExcellent communication skills, both oral and writtenStrong interpersonal, networking and relationship skills required, including team work and listening skillsApply now Share by email Print this pageYour ContactAmélie CurchodFresenius Kabi SwissBioSim GmbHRef. number : 52447>
  • fresenius

  • kabi.comAt a glanceCareer level : Professional ExperiencedJob category : Research & DevelopmentWorking condition : Permanent / Full
  • timeBusiness segment : Fresenius KabiLocation : Eysins / InternationalClosing date for applications : none
  • we look forward to your applicationAbout FreseniusOver 300,000 people across the globe work at Fresenius to provide better medicine for more people.
  • Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector.

    We offer you the opportunity to make a difference with your career

  • and to become part of our impressive growth story.>

    fresenius.comOne of Fresenius strengths : our corporate culture for "entrepreneurs in an enterprise" where you can quickly take on responsibility.

    The benefits we offer : Profit

  • sharing, long
  • term accounts for your future plans and other benefits which meet individual needs.>
  • More reasons>

    More benefitsFresenius Kabi SwissBioSim GmbH https : / / / kcenter

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  • 18740 / logo google kabi.png2022
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