director - analytical lifecycle strategy.

• 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 check
• Participate in review of change control and associated risk and impact assessment
• 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.
• 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 sites
 

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