Vice President, Biologics Process Development

Vice President, Biologics Process Development

Company:
Ipsen Biopharm Ltd

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas:
Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries.

We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at  and follow our latest news on Linked In and Instagram.

The VP, Biologics Process Development will be responsible for leading the Biologics Process Development (BPD) organization  deliver the Biologics Process Development (BPD) strategy and operational requirements, as part of the global Pharmaceutical Development (Pharm Dev) 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 Pharm Dev and R&D/Tech Ops Stakeholders & External partners (CDMOs), to ensure successful global product development and regulatory approvals.

• 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 transfer to routine manufacture in-house/third party contractors.
• Lead the development groups within BPD; incorporating recruitment, empowerment, operational prioritization and development of managers and staff to ensure the group has the necessary skills, knowledge, motivation and leadership abilities to perform their roles effectively.
• Manage regular BPD leadership and Department meetings.
• Identify, implement and maintain fit-for-purpose functional technologies, capabilities and staff expertise to support biologics’ pipeline requirements; ensuring personal development, performance, talent management and succession management are integrated and aligned with IPSEN ways of working.
• Build strong collaborative global relationships and proactively engage with key stakeholders across and outside of the business to drive forward and support the Ipsen Biologics strategy.
• Provide proactive membership of the global Pharm Dev Leadership Team (PDLT), engaging and supporting global Pharm Dev initiatives, alignment and global practices working closely with the other PDLT members.
• Lead close…