CMC Lead (Neurotoxins & Biologics)

TL;DR

CMC Lead (Neurotoxins & Biologics): Providing end-to-end CMC leadership for neurotoxin and biologics development programs with an accent on cross-functional strategy, regulatory compliance, and technical execution. Focus on driving asset team objectives, managing complex CMC risks, and ensuring seamless alignment across drug substance, analytical, and supply chain operations.

Location: Must be based in or able to work from Wrexham or London, UK (Hybrid/Onsite)

Company

hirify.global is a global biopharmaceutical company focused on transformative medicines in oncology, rare disease, and neuroscience, supported by nearly 100 years of development experience.

What you will do

• Lead CMC strategy and delivery for assigned neurotoxin and biologics programs.
• Represent CMC on asset teams, translating development objectives into actionable plans.
• Drive cross-functional collaboration across R&D, quality, regulatory, and technical operations.
• Support CMC governance, including risk tracking, KPI reporting, and milestone management.
• Ensure compliance with GxP, quality, EHS, and scientific integrity standards.
• Align program needs with Wrexham site leadership and operational excellence initiatives.

Requirements

• PhD in a relevant scientific discipline or equivalent experience.
• 7+ years of experience in CMC pharmaceutical development, specifically within biologics.
• Proven track record in CMC strategy development and delivery.
• Experience leading cross-functional matrix teams.
• Strong understanding of GMP and ICH guidelines.
• Fluent English required.

Nice to have

• 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.

Culture & Benefits

• Work at a flagship manufacturing and development site with significant ongoing investment.
• Collaborative, science-driven, and people-focused environment.
• Hybrid working model.
• Commitment to professional development and operational excellence.