Director Analytical Lifecycle Strategy

vor 3 Wochen

Eysins, Schweiz FRESENIUS_KABI Vollzeit

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 assignments

Functional Goal:

Provide strategic leadership and oversight of analytical lifecycle management for commercial biosimilar products.

Main Tasks:

Strategic oversight: Develop and implement strategies to ensure analytical methods remain compliant with MAAs / BLAs and with evolving regulatory requirements. Ensure cross-product deployment of strategy. Collaborate with interdisciplinary teams to provide strategic analytical direction and guidance; Management: Coordinate a group of subject matter experts in charge of product-specific analytical lifecycle management. Mentor and develop staff in their career path.
Represent the group, work with peers and manager to ensure delivery on the objectives and smooth interactions within the Biopharmaceutical Product Development function; Method transfer: Oversee the effective and compliant transfer of analytical methods for release and stability testing between laboratories or sites; Routine maintenance and monitoring:
In conjunction with QA / QC departments at site ensure oversight of trending, review and assessment of the performance of established analytical methods across the DS/DP manufacturing chain.
Ensure implementation of necessary adaptations based on product, process or method changes.
Identify method gap and risk associated with existing / modification of existing methods and towards implementation of new analytical methods; Technical troubleshooting: Provide expertise in resolving technical issues related to analytical methods, instruments or processes; Regulatory and Quality compliance:
Stay updated with regulatory guidelines and industry best practices. Ensure all analytical methodologies meet current pharmacopeial and regulatory requirements. Support filing of dossier variations / updates. Draft / review response to queries and observation from Health Authorities.
Provide support during inspections and audits.
Participate in analytical deviation and OOx investigation, root cause identification, appropriate CAPA, and CAPA effectiveness check
Participate in review of change control and associated risk and impact assessment; Documentation and reporting:
Ensure maintenance of comprehensive documentation of method development, validation, transfer and monitoring activities.
Review / approve technical studies at internal and various external laboratories. Review / approve stability and comparability protocols and reports; Cross-functional collaboration:
Build and sustain strong interface with CROs and CMOs critical to the success of product maintenance. Manage project activities, supervise and co-ordinate various sponsored / external laboratories.
Collaborate with quality and regulatory teams to ensure a holistic approach to product life cycle management.
Provide expertise and assistance to Technical Operations.
Collaborate with Regulatory Affairs to ensure alignment with global regulatory expectations.

Other Tasks:  

May serve as a member of CMC and/or TT team(s); Represent Analytics in various technical forums within and outside organization.

Your profile

Education

Master’s degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field. PhD degree is a plus.

Languages

Fluency in English essential, both oral and written to a high professional standard; additional languages (French, German, Spanish) are an asset.

Work experience

Minimum of 10 years experience in pharmaceutical analytical development or a related field in the biopharma industry, essential within the biotherapeutic field including antibodies; Demonstrated experience in analytical method development, validation, tech transfer and troubleshooting in QC environment. In depth experience in analytical sciences applied to proteins / mAbs and familiar with state of the art biochemical and biophysical analytical methods; People management experience and/or competencies required; Strong understanding of global pharmaceutical regulations, ICH guidelines and GMP requirements; Significant exposure to / understanding of cross-functional CMC development of biotherapeutics; Track record of successful interactions with Health Authorities in highly regulated markets; Demonstrated success operating in a global matrix organization with the full breadth of functions contributing to drug development.

  • Dsp Director

    vor 4 Wochen

    Eysins, Schweiz BioTalent Vollzeit

    BioTalent are partnering with a globally leading pharmaceutical company based in the Vaud region of Switzerland, to support the hire of a Director of Downstream Processing with expertise in the development and manufacture of biosimilars from mammalian cell systems. This role will offer you - The opportunity to lead and direct an exciting DSP division,...

  • Director Clinical Operations

    Vor 2 Tagen

    Eysins, Schweiz Fresenius Kabi Vollzeit

    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...

  • Global Operational Excellence Director

    Vor 2 Tagen

    Eysins, Schweiz BD Vollzeit

    **Job Description Summary**: **We are the makers of possible**: BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech...

  • Director Global Project Manager

    vor 4 Wochen

    Eysins, Schweiz Fresenius Kabi Vollzeit

    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...

  • Commercial Support Executive Temp

    vor 2 Wochen

    Eysins, Schweiz PUIG, S.L. Vollzeit

    The Opportunity This temporary role reports to the Commercial Area Manager within EMAD (European, Mediterranean and African Distributors), providing operational support in overseeing the daily management of the Distributors markets, ensuring effective communication with all stakeholders. Additionally, this position involves assisting and maintaining a...

  • Commercial Support Executive Temp

    vor 2 Wochen

    Eysins, Schweiz PUIG, S.L. Vollzeit

    The OpportunityThis temporary role reports to the Commercial Area Manager within EMAD (European, Mediterranean and African Distributors), providing operational support in overseeing the daily management of the Distributors markets, ensuring effective communication with all stakeholders. Additionally, this position involves assisting and maintaining a...

  • EMAD Finance Controller

    vor 3 Wochen

    Eysins, Schweiz PUIG, S.L. Vollzeit

    The OpportunityWe are seeking a highly motivated Finance Controller to join our dynamic EMAD (European, Mediterranean and African Distributors) team. This position will start as a temporary role for 12 months with the high potential to transition into a permanent role. Your mission will be to support the EMAD Finance Director in budgeting, financial...

  • Director Regulatory Affairs Cmc

    vor 4 Wochen

    Eysins, Schweiz Fresenius Kabi Vollzeit

    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...

  • CRO MANAGER CDD 6 months

    vor 3 Wochen

    Eysins, Schweiz TAG Heuer, succursale de LVMH Swiss Manufactures SA Vollzeit

    CRO MANAGER CDD 6 months (H/F)Société : TAG Heuer Pays / Region : Suisse Ville : Eysins Secteur d'activités : Montres & Joaillerie Type de contrat : CDD Métier : Digital Expérience requise : Minimum 5 ans Référence : TAGH01694 Date de publication : PosteSince 1860, TAG Heuer has embodied the avant-garde, precision and bold style that have shaped the...

  • CRO MANAGER CDD 6 months

    Vor 6 Tagen

    Eysins, Schweiz TAG Heuer, succursale de LVMH Swiss Manufactures SA Vollzeit

    CRO MANAGER CDD 6 months (H/F) Société : TAG Heuer Pays / Region : Suisse Ville : Eysins Secteur d'activités : Montres & Joaillerie Type de contrat : CDD Métier : Digital Expérience requise : Minimum 5 ans Référence : TAGH01694 Date de publication : 17.04.2024 Poste Since 1860, TAG Heuer has embodied the avant-garde, precision and bold style that...

  • TR Education and Shoppers Experience Executive

    vor 3 Wochen

    Eysins, Schweiz Puig Vollzeit

    What you´ll get to do- Coordinate education department’s creative projects and retail tools, both digital and non-digital (including apps).- Builds and maintains a comprehensive information system for a variety of Education materials such as product knowledge, display concepts, sales techniques, promotion programs, and system/procedural requirements.-...

  • Commercial Intern

    vor 2 Wochen

    Eysins, Schweiz PUIG, S.L. Vollzeit

    The Opportunity We are looking for a Commercial Intern to join our EMED (European and Mediterranean Distributors) team in Eysins. In this role, you will be an integral part of our team, contributing to the company’s growth objectives and strategies. You will be providing operational support to the Europe Commercial team in the process of managing...

  • Commercial Intern

    vor 2 Wochen

    Eysins, Schweiz PUIG, S.L. Vollzeit

    The OpportunityWe are looking for a Commercial Intern to join our EMED (European and Mediterranean Distributors) team in Eysins. In this role, you will be an integral part of our team, contributing to the company's growth objectives and strategies. You will be providing operational support to the Europe Commercial team in the process of managing Distributors...