Senior MS&T Specialist

Titre :

Senior MS&T Specialist

Société:

Ipsen Biopharm Ltd

A propos d'Ipsen:

Ipsen est un groupe biopharmaceutique mondial de taille moyenne, spécialisé dans les médicaments transformateurs dans trois aires thérapeutiques : l'oncologie, les maladies rares et les neurosciences. Forts de près de 100 ans d'expérience en développement, avec des Hubs mondiaux aux États-Unis, en France et au Royaume-Uni, nous focalisons nos efforts là où les besoins médicaux non satisfaits sont importants, grâce à la recherche et à l'innovation.

Nos équipes passionnées, présentes dans plus de 40 pays, se concentrent sur l'essentiel et s'efforcent chaque jour d'apporter des médicaments aux patients dans 88 pays. Nous construisons un environnement de travail qui met en avant un leadership centré sur l'humain et favorise une culture de collaboration, d'excellence et d'impact. Au sein d’Ipsen, chaque individu est encouragé à être soi-même, à grandir et à s’épanouir aux côtés du succès de l'entreprise. Rejoignez-nous dans notre démarche vers une croissance durable, en créant un impact réel sur les patients et la société.

Pour plus d'informations, visitez notre site web à l'adresse https://www.ipsen.com et suivez nos dernières actualités sur LinkedIn et Instagram.

Description de l'emploi :

We are looking for an experienced MS&T Senior Specialist/Drug Substance Expert to provide technical leadership and subject matter expertise across small molecule drug substance manufacturing.

This is an opportunity to work across the full product lifecycle, supporting development, scale-up, technology transfer, validation, commercial manufacturing and lifecycle management. You’ll collaborate across R&D, Quality, Regulatory Affairs, Manufacturing and Supply Chain, while building strong technical partnerships with CMOs and external partners globally.

What you’ll be doing

• 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.

What you’ll bring

Essential:

• 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.

Desirable:

• Experience working with or within a CMO/CDMO environment.
• Experience with biological drug substance and/or Antibody-Drug Conjugates (ADCs).
• PhD-level qualification in natural science, chemistry or a related discipline.
• An understanding of French would be beneficial.

Why Ipsen?

At Ipsen, you’ll have the opportunity to bring deep technical expertise to complex challenges, collaborate across functions and external partners, and contribute across the lifecycle of products that can make a real difference for patients.

If you’re passionate about drug substance manufacturing, enjoy solving complex technical challenges and want to use your expertise in a collaborative, international environment, we’d love to hear from you.

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We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.