Director - Analytical Lifecycle Strategy
vor 3 Wochen
For our client specialized in Life Science industry and based in Vaud canton, we're looking for a Director - Analytical Lifecycle Strategy
Mains tasks
Development and implementation 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 strategicanalytical direction and guidance.Coordination of 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 BPD.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.Provide expertise in resolving technical issues related to analytical methods, instruments or processes.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 checkParticipate in review of change control and associated risk and impact assessmentEnsure 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.Build and sustain strong interface with CROs and CMOs critical to the success of product maintenance. Manage project activities, supervise and coordinate 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. Travel (up to 10%) may occur between the different sitesEducation 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 methodsPeople management experience and/or competencies requiredStrong understanding of global pharmaceutical regulations, ICH guidelines and GMP requirementsSignificant exposure to / understanding of cross-functional CMC development of biotherapeuticsTrack record of successful interactions with Health Authorities in highly regulated marketsDemonstrated success operating in a global matrix organization with the full breadth of functions contributing to drug development
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