Senior Small Molecule DS Expert & Tech Transfer Lead

Ipsen; England; Híbrido; GBP 85.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work model

Descripción de la vacante

Ipsen is seeking an experienced MS&T Senior Specialist/Drug Substance Expert to provide technical leadership across small molecule drug substance manufacturing. You will work across the full product lifecycle, coordinating with R&D, QA, Regulatory Affairs, Manufacturing and Supply Chain while partnering with CMOs globally.

The role requires leading tech transfer, validation, and lifecycle management, with emphasis on regulatory compliance and supply continuity in a hybrid environment.

Formación

• Strong hands-on knowledge of small molecule drug substance manufacturing processes.
• Experience leading technology transfer activities.
• Ability to lead cross-functional teams and manage stakeholders.

Responsabilidades

• Act as SME for small molecule drug substance manufacturing across projects.
• Provide technical leadership for external manufacturing of drug substance and drug product.
• Lead technology transfer and validation activities with protocol development and timelines.
• Support transition from Phase III to commercial launch, ensuring readiness and regulatory compliance.
• Collaborate with Regulatory Affairs on drug substance sections for submissions.
• Lead issue resolution, risk analysis, and continuous improvement with CMOs.
• Analyze process/analytical data to support regulatory activities.
• Build relationships with CMOs and cross-functional stakeholders.
• Lead complex projects while coaching team members.

Conocimientos

Small molecule manufacturing

Technology transfer

Leadership

Educación

Degree in natural science/chemistry or related

Descripción del empleo

Ipsen is seeking an experienced MS&T Senior Specialist/Drug Substance Expert to provide technical leadership across small molecule drug substance manufacturing. You will work across the full product lifecycle, coordinating with R&D, QA, Regulatory Affairs, Manufacturing and Supply Chain while partnering with CMOs globally.

The role requires leading tech transfer, validation, and lifecycle management, with emphasis on regulatory compliance and supply continuity in a hybrid environment.