CMC Lead – Neurotoxins & Biologics

At Ipsen, we are committed to improving the lives of patients through innovative medicines, with a strong focus on Neuroscience and biologics development. Our Wrexham site plays a critical role in advancing Ipsen’s neurotoxin and biologics portfolio and is recognised as a Great Place to Work® and a Shingo Bronze Medallion holder, reflecting our commitment to operational excellence, innovation, and continuous improvement.

With a recent £24 million investment in the site and a further £86.4 million expansion underway, there has never been a more exciting time to join us. If you are passionate about making an impact and want to be part of a team that values growth, innovation, and excellence, then Ipsen could be where you thrive!

As CMC Lead – Neurotoxins & Biologics, you will play a pivotal leadership role in advancing Ipsen’s Neurotoxin Franchise and broader biologics portfolio. Reporting to the Senior Director, Neurotoxins CMC Leadership & Strategy, you will provide end‑to‑end CMC leadership across assigned development programmes, ensuring high‑quality execution, robust CMC strategy, and seamless cross‑functional alignment.

You will act as the CMC representative on asset teams, leading cross‑functional CMC sub‑teams and ensuring CMC plans, risks, and timelines are clearly defined and delivered to support clinical progression, regulatory submissions, approvals, and lifecycle management.

• Lead CMC strategy and delivery for assigned neurotoxin and biologics programmes, ensuring robust planning, execution, risk management, and cross‑functional alignment across Drug Substance, Drug Product, Analytical, Quality, Regulatory CMC, Supply Chain, and Technical Operations.
• Represent CMC on asset teams, translating development objectives into clear, actionable CMC plans aligned with clinical and regulatory strategy.
• Contribute to therapy area and portfolio planning, ensuring CMC risks, opportunities, and future development needs are reflected in franchise‑level decision‑making.
• Drive cross‑functional collaboration with R&D, Pharmaceutical Development, Neuroscience TA, Neurotoxin Franchise, Clinical Operations, Early Development, and Technical Operations to ensure CMC readiness and programme progression.
• Support CMC governance, including risk tracking, KPI reporting, milestone management, and consistent application of CMC standards and ways of working.
• Engage with the Wrexham site leadership, aligning programme needs with site priorities and contributing to initiatives that strengthen operational excellence and technical capability.
• Ensure compliance with GxP, quality, EHS, and scientific integrity standards at all times.

Essential

• PhD in a relevant scientific discipline (or equivalent experience)
• Extensive experience (typically 7+ years) in CMC pharmaceutical development, ideally within biologics
• Proven track record in CMC strategy development and delivery for biological products
• Experience leading cross‑functional matrix teams
• Strong understanding of GMP, ICH guidelines, and regulatory expectations
• Excellent communication skills with the ability to present complex technical information clearly
• Demonstrated ability to manage technical complexity, risk, and interdependencies across programmes
• Fluent English

• Previous experience as a CMC Lead for complex biological or neurotoxin products
• Experience operating across portfolio‑level CMC governance
• Project management accreditation
• Knowledge of structured problem‑solving methodologies
• French language skills

• Be part of a flagship manufacturing and development site with major ongoing investment
• Play a critical role in advancing neurotoxin and biologics therapies that make a real difference for patients
• Work in a highly collaborative, science‑driven, and people‑focused environment
• Benefit from Ipsen’s hybrid working model, strong development culture, and commitment to excellence

#LI‑Hybrid #LI‑Onsite #LI‑Wrexham