The VP, Biologics Process Development will be responsible for leading the Biologics Process Development (BPD) organization at IPSEN. To deliver the Biologics Process Development (BPD) strategy and operational requirements, as part of the global Pharmaceutical Development (PharmDev) organization. Leading the CMC drug substance process development of all novel Biologics products; including toxins, monoclonal antibodies, antibody drug conjugates, enzymes and other Biologics products developed and in-licensed by IPSEN, from candidature selection to commercialization and life-cycle programs. Managing the teams across Biologics Process and Analytical Development groups, acting as Sponsor for Biologics CMC projects, working effectively with global PharmDev and R&D/TechOps Stakeholders & External partners (CDMOs), to ensure successful global product development and regulatory approvals.
Main Responsibilities & Technical Competencies
Accountable for defining and delivering a coordinated, comprehensive and strategic CMC process development program for novel toxins, antibodies and other biologics developed/in-licensed by Ipsen across therapeutic areas. Lead the design, development, validation and industrialization of bioprocesses through all stages of development from pre-clinical, clinical to launch and lifecycle; ensuring that robust drug substance processes, analytics, specifications, regulatory documents are delivered for all product development plans; ensuring a science-based approach to ensure effective product - process understanding in line with regulatory requirements; achieve first time regulatory approvals and effective tech
Vice President, Biologics Process Development in London employer: Ipsen
Ipsen Biopharm Ltd is an exceptional employer that prioritises a human-centric workplace culture, fostering collaboration and excellence. With a commitment to employee growth, Ipsen offers opportunities for continuous improvement and innovation in the biopharmaceutical field, particularly in vibrant locations like Paris and London. Employees are empowered to thrive, making a meaningful impact on patients and society while enjoying a supportive environment that values diverse perspectives.
