Director Analytical Lifecycle Strategy - Eysins, Schweiz - Fresenius Kabi
Beschreibung
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;
- 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.
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:
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:
Review / approve technical studies at internal and various external laboratories. Review / approve stability and comparability protocols and reports;
- Crossfunctional collaboration:
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
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