Overview
As a Senior MS&T Specialist/Drug Substance Expert, you will provide technical leadership for small molecule drug substance manufacturing across the product lifecycle. You will collaborate with R&D, Quality, Regulatory, Manufacturing, and Supply Chain, as well as external CMOs, to ensure readiness, compliance, and reliable supply. You will lead technology transfer, validation, and complex projects that impact scale-up and lifecycle activities. This role offers meaningful impact by shaping manufacturing strategies in a global, cross-functional environment.
Responsibilities
- Act as subject matter expert for small molecule drug substance manufacturing across products and projects
- Lead external manufacturing activities for drug substance and drug product manufacture and testing
- Drive technology transfer and validation, including protocol development and delivery against quality, cost, and timelines
- Support transition from Phase III to commercial launch, ensuring readiness, regulatory compliance, and supply continuity
- Partner with Regulatory Affairs on drug substance sections and regulatory submissions
- Lead technical issue resolution, risk analysis, troubleshooting, and continuous improvement with external 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 priorities and mentoring team members
Key requirements
- Strong knowledge and hands-on experience in small molecule drug substance manufacturing processes
- Experience in technology transfer
- Degree or higher in natural science, chemistry or related discipline
- Professional-level English
- Ability to lead cross-functional teams, manage stakeholders, and make independent, risk-based decisions aligned with Ipsen strategy
- Cross-functional collaboration
- Stakeholder management
- Analytical thinking
- Small molecule drug substance manufacturing
- Technology transfer
- Validation activities
Senior MS&T Specialist in Wrexham employer: Ipsen
Ipsen Biopharm Ltd is an exceptional employer that prioritises a human-centric workplace culture, fostering collaboration and excellence. With a commitment to employee growth, Ipsen offers opportunities for continuous improvement and innovation in the biopharmaceutical field, particularly in vibrant locations like Paris and London. Employees are empowered to thrive, making a meaningful impact on patients and society while enjoying a supportive environment that values diverse perspectives.
