Director Analytical Lifecycle Strategy

vor 1 Woche

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 crossproduct deployment of strategy. Collaborate with interdisciplinary teams to provide strategic analytical direction and guidance;
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;

  • Crossfunctional 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.

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 crossfunctional 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.


 Auf einen Blick
  • Standort:


InternationalEysins
  • Karrierelevel

  • Director Analytical Lifecycle Strategy

    Vor 5 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 Senior Marketing Director, Infusion Consumables

    vor 1 Woche

    Eysins, Schweiz Becton Dickinson AG Vollzeit

    Global Senior Marketing Director, Infusion ConsumablesJob 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 healthTM 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...

  • Marketing Director

    vor 2 Wochen

    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...

  • Dsp Director

    vor 2 Monaten

    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,...

  • Commercial Excellence Director Mds Emea

    vor 1 Woche

    Eysins, Schweiz BD Vollzeit

    Job Description Summary: Reporting to the VP/GM MDS EMEA, and as a member of the MDS EMEA Leadership Team, the Commercial Excellence Director provides strategic leadership in MDS' transformation to a customer-centric solution provider. This role is responsible for initiating, driving and recommending strategic insights and direction with regards to future...

  • Commercial Excellence Director Mds Emea

    vor 2 Monaten

    Eysins, Schweiz BD Vollzeit

    **Job Description Summary**: Reporting to the VP/GM MDS EMEA, and as a member of the MDS EMEA Leadership Team, the Commercial Excellence Director provides strategic leadership in MDS’ transformation to a customer-centric solution provider. This role is responsible for initiating, driving and recommending strategic insights and direction with regards to...

  • Commercial Excellence Director Mds Emea

    vor 4 Wochen

    Eysins, Schweiz BD Vollzeit

    **Job Description Summary**: Reporting to the VP/GM MDS EMEA, and as a member of the MDS EMEA Leadership Team, the Commercial Excellence Director provides strategic leadership in MDS’ transformation to a customer-centric solution provider. This role is responsible for initiating, driving and recommending strategic insights and direction with regards to...

  • Operations Director

    vor 4 Wochen

    Eysins, Schweiz IMI Precision Engineering Vollzeit

    **IMI plc** We are a global specialist engineering company that creates breakthrough solutions. We are curious and like to solve problems, partnering with our customers to solve the demands of today and prepare for the challenges of tomorrow. We embrace innovation and care about outcomes that are good for business, everyday life and making a better world -...

  • Operations Director

    Vor 2 Tagen

    Eysins, Schweiz IMI Precision Engineering Vollzeit

    **IMI plc** We are a global specialist engineering company that creates breakthrough solutions. We are curious and like to solve problems, partnering with our customers to solve the demands of today and prepare for the challenges of tomorrow. We embrace innovation and care about outcomes that are good for business, everyday life and making a better world -...

  • (Senior) Manager CMC Analytical Life Cycle

    vor 1 Monat

    Eysins, Schweiz FRESENIUS_KABI Vollzeit

    At Fresenius Kabi Biosimilars, we want to make a difference. With our principle "we care for excellence" we relentlessly strive to provide easier access to high-quality, affordable medicines to more patients around the world. Being part of Fresenius Kabi, we are a global company with strong growth opportunities and a unique expertise in healthcare, which...

  • (Senior) Manager CMC Analytical Life Cycle

    vor 4 Wochen

    Eysins, Schweiz FRESENIUS_KABI Vollzeit

    At Fresenius Kabi Biosimilars, we want to make a difference. With our principle "we care for excellence" we relentlessly strive to provide easier access to high-quality, affordable medicines to more patients around the world. Being part of Fresenius Kabi, we are a global company with strong growth opportunities and a unique expertise in healthcare, which...

  • Operations Director

    vor 1 Woche

    Eysins, Schweiz IMI Precision Engineering Vollzeit

    IMI plcWe are a global specialist engineering company that creates breakthrough solutions. We are curious and like to solve problems, partnering with our customers to solve the demands of today and prepare for the challenges of tomorrow. We embrace innovation and care about outcomes that are good for business, everyday life and making a better world -...

  • Operations and Supply Chain Director

    Vor 4 Tagen

    Eysins, Schweiz IMI Precision Engineering Vollzeit

    **IMI plc** We are a global specialist engineering company that creates breakthrough solutions. We are curious and like to solve problems, partnering with our customers to solve the demands of today and prepare for the challenges of tomorrow. We embrace innovation and care about outcomes that are good for business, everyday life and making a better world -...

  • Regulatory Affairs Director

    vor 3 Wochen

    Eysins, Schweiz BD Philippines Vollzeit

    **Be part of something bigger at BD.** Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning...

  • Associate Director Connected Medication Management

    vor 3 Wochen

    Eysins, Schweiz BD Vollzeit

    **Job Description Summary**: === ABOUT THIS BUSINESS PLATFORM: === The Worldwide Infusion Preparation and Delivery/International Infusion is a global $1.4B platform, focused on enabling safe, efficient, and effective preparation and delivery of infusion therapies across the continuum of care settings around the world. **We are the makers of possible**: BD...

  • Associate Director Connected Medication Management

    vor 3 Wochen

    Eysins, Schweiz BD Philippines Vollzeit

    **JOB ID** R-477607 **DATE POSTED** 10/29/2023 **Job Description Summary**: === ABOUT THIS BUSINESS PLATFORM: === The Worldwide Infusion Preparation and Delivery/International Infusion is a global $1.4B platform, focused on enabling safe, efficient, and effective preparation and delivery of infusion therapies across the continuum of care settings around...

  • Global Operational Excellence Director

    vor 3 Wochen

    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...

  • Global Operational Excellence Director

    vor 1 Woche

    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 products per...

  • Director Pipeline Growth

    vor 1 Woche

    Eysins, Schweiz Merck KGaA Darmstadt Germany Vollzeit

    Work Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...

  • Director Downstream Process Development

    vor 1 Woche

    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...