CMC Lead – Neurotoxins & Biologics

Join Our AwardWinning Team at Ipsen Wrexham

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 Ipsens 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!

Role Summary

As CMC Lead Neurotoxins & Biologics you will play a pivotal leadership role in advancing Ipsens Neurotoxin Franchise and broader biologics portfolio. Reporting to the Senior Director Neurotoxins CMC Leadership & Strategy you will provide endtoend CMC leadership across assigned development programmes ensuring highquality execution robust CMC strategy and seamless crossfunctional alignment.

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

In This Role You Will:

• Lead CMC strategy and delivery for assigned neurotoxin and biologics programmes ensuring robust planning execution risk management and crossfunctional 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 franchiselevel decisionmaking.
• Drive crossfunctional 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.

Requirements

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 crossfunctional 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

Preferred

• Previous experience as a CMC Lead for complex biological or neurotoxin products
• Experience operating across portfoliolevel CMC governance
• Project management accreditation
• Knowledge of structured problemsolving methodologies
• French language skills

Why Join Ipsen Wrexham

• 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 sciencedriven and peoplefocused environment
• Benefit from Ipsens hybrid working model strong development culture and commitment to excellence

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