Senior MS&T Lead — Small Molecule Drug Substance

Ipsen; Paris; On-site; EUR 70,000 - 110,000; Full time

Job summary

Ipsen Biopharm Ltd is seeking an experienced MS&T Senior Specialist to provide technical leadership across small molecule drug substance manufacturing. You will collaborate across R&D, Quality, Regulatory Affairs, Manufacturing and Supply Chain with CMOs and external partners globally.

The role covers development, scale-up, technology transfer, validation and lifecycle management, influencing manufacturing readiness and regulatory compliance from Phase III to launch.

Qualifications

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

Responsibilities

• Act as a SME 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 development through to commercial launch, ensuring manufacturing readiness and regulatory compliance.
• 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 relationships with CMOs and cross-functional stakeholders.
• Lead complex technical projects, balancing priorities while coaching and supporting others.

Skills

Small molecule DSM

Technology transfer

Cross-functional leadership

Risk-based decisions

English proficiency

Education

Degree in natural science/chemistry

Job description

Ipsen Biopharm Ltd is seeking an experienced MS&T Senior Specialist to provide technical leadership across small molecule drug substance manufacturing. You will collaborate across R&D, Quality, Regulatory Affairs, Manufacturing and Supply Chain with CMOs and external partners globally.

The role covers development, scale-up, technology transfer, validation and lifecycle management, influencing manufacturing readiness and regulatory compliance from Phase III to launch.