Vice President, Biologics Process Development

Overview

In this role you lead Ipsen’s Biologics Process Development organization, shaping the strategy and execution of CMC development for novel biologics from candidate to commercialization. You will manage global teams, collaborate with PharmDev, R&D/TechOps, and external partners to deliver robust biologics processes and regulatory-ready submissions. You drive tech transfer, lifecycle programs, and site leadership at Wrexham, delivering high-impact patient outcomes. This is a chance to influence the biologics pipeline and convert scientific advances into approved therapies.

Responsibilities

• Define and execute a coordinated CMC process development program for toxins, antibodies, ADCs, enzymes and other Ipsen biologics across development stages
• Lead design, development, validation and industrialization of bioprocesses; ensure robust drug substance processes, analytics and regulatory documents
• Recruit and develop the BPD team, set priorities, and manage leadership meetings
• Manage external partnerships (CDMOs) and cross-functional governance with global PharmDev, R&D/TechOps, Quality, and CMC leadership
• Guide technology strategy, capabilities, and succession planning aligned with Ipsen’s ways of working
• Build global collaboration with Research, External Innovation, Early Development and Clinical Development; coordinate with TechOps for end-to-end development and manufacturing
• Oversee external asset due diligence, integration activities, and external partnering initiatives
• Lead continuous improvement, benchmarking, and budget/capital investment planning for BPD

Key requirements

• Extensive biologics CMC development experience and leadership in a pharmaceutical regulatory environment
• Significant leadership experience in global Pharmaceutical Development and CMC with a track record of moving programs from early development to commercialization
• Broad expertise across CMC disciplines (DS, DP, Analytics) and regulatory awareness including Module 3 submissions
• Strong budget, staffing management, and cross-cultural leadership skills
• Excellent communication and stakeholder management abilities across diverse teams

• Collaborative and influential leadership
• Strategic thinking with results orientation
• Effective communication across functions and geographies
• CMC process development for biologics (toxins, antibodies, ADCs, enzymes)
• Process development from preclinical to launch and lifecycle
• Regulatory writing and submissions (Module 3)

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