Senior MS&T Lead - Drug Substance

Ipsen Biopharm Ltd; Greater London; Ibrido; GBP 80.000 - 110.000; Tempo pieno

Descrizione del lavoro

Ipsen Biopharm Ltd in the United Kingdom is seeking an experienced MS&T Senior Specialist/Drug Substance Expert to provide technical leadership across small molecule drug substance manufacturing.

You will support development, scale-up, technology transfer, validation and lifecycle management while collaborating with R&D, Quality, Regulatory Affairs, Manufacturing and Supply Chain, and building strong partnerships with CMOs.

Competenze

• Strong knowledge and hands-on experience in small molecule drug substance manufacturing processes.
• Experience in technology transfer.
• A degree or higher qualification in natural science, chemistry or a related discipline.
• Professional-level English.
• The ability to lead cross-functional teams, manage stakeholders and make independent, risk-based decisions aligned with Ipsen strategy.

Mansioni

• Act as a Subject Matter Expert for small molecule drug substance manufacturing, providing technical leadership across assigned products and projects.
• Provide technical leadership for external manufacturing products, covering drug substance and drug product manufacture and testing.
• Lead technology transfer and validation activities, including protocol development and delivery against quality, cost and timeline expectations.
• Support the transition of products from Phase III clinical development through to commercial launch, helping ensure manufacturing readiness, regulatory compliance and supply continuity.
• Partner with Regulatory Affairs on drug substance sections and responses for regulatory submissions.
• Lead technical issue resolution, risk analysis, troubleshooting and continuous improvement with external manufacturing partners.
• Analyse and trend process and analytical data to support technical and regulatory activities.
• Build strong relationships with CMOs and cross-functional stakeholders.
• Lead complex technical projects, balancing multiple priorities while coaching and supporting other team members.

Conoscenze

Small molecule drug substance

Technology transfer

Cross-functional leadership

English proficiency

Formazione

Natural science/chemistry degree

Descrizione del lavoro

Ipsen Biopharm Ltd in the United Kingdom is seeking an experienced MS&T Senior Specialist/Drug Substance Expert to provide technical leadership across small molecule drug substance manufacturing.

You will support development, scale-up, technology transfer, validation and lifecycle management while collaborating with R&D, Quality, Regulatory Affairs, Manufacturing and Supply Chain, and building strong partnerships with CMOs.