Ipsen seeks an experienced Senior MS&T Specialist to lead small molecule drug substance manufacturing across the product lifecycle. The role involves technical oversight of development, scale-up, technology transfer, and commercial manufacturing, with cross-functional collaboration across R&D, Quality, Regulatory Affairs, and external manufacturing partners.
Responsibilities
- Provide subject matter expertise and technical leadership for small molecule drug substance manufacturing across assigned products
- Lead technology transfer and validation activities, including protocol development and execution
- Support product transition from Phase III development through commercial launch, ensuring manufacturing readiness and regulatory compliance
- Lead technical issue resolution, risk analysis and continuous improvement initiatives with manufacturing partners
- Collaborate with Regulatory Affairs on drug substance sections and regulatory submission responses
Requirements
- Hands-on experience in small molecule drug substance manufacturing processes
- Demonstrated experience in technology transfer activities
- Degree or higher qualification in natural science, chemistry, or related discipline
- Professional-level English language proficiency
- Ability to lead cross-functional teams and make independent risk-based decisions
- CMO/CDMO environment experience (desirable)
- PhD-level qualification in chemistry or natural science (desirable)
Vacancy posted 9 days ago
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