- 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.
- May serve as a member of CMC and/or TT team(s);
- Represent Analytics in various technical forums within and outside organization.
- Master's degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field. PhD degree is a plus.
- Fluency in English essential, both oral and written to a high professional standard; additional languages (French, German, Spanish) are an asset.
- 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.
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Director Analytical Lifecycle Strategy - Eysins, Schweiz - FRESENIUS_KABI
vor 1 Woche
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:
Other Tasks:
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