Senior MS&T Specialist

Ipsen Biopharmaceuticals Inc.; Greater London; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

Ipsen Biopharm Ltd in the United Kingdom is seeking a Senior MS&T Specialist to provide technical leadership across small molecule drug substance manufacturing. The role spans development, scale-up, tech transfer, validation, and lifecycle management, collaborating with R&D, Quality, Regulatory Affairs, Manufacturing and Supply Chain.

You will lead external manufacturing partnerships, oversee technology transfer, and drive regulatory readiness while ensuring supply continuity and quality across

Qualifications

• Strong knowledge and hands-on experience in small molecule drug substance manufacturing.
• Experience in technology transfer and scaling processes.
• Professional-level English for global collaboration.
• Ability to lead cross-functional teams and manage stakeholders.

Responsibilities

• Act as a Subject Matter Expert for small molecule drug substance manufacturing across products and projects.
• Provide technical leadership for external manufacturing, covering drug substance and drug product manufacture and testing.
• Lead technology transfer and validation activities with quality, cost, and timeline focus.
• Support transitions from Phase III to commercial launch ensuring readiness and supply continuity.
• Partner with Regulatory Affairs on drug substance sections for submissions.
• Lead technical issue resolution and risk analysis with external partners.
• Analyse and trend process and analytical data to support regulatory activities.
• Build strong relationships with CMOs and cross-functional stakeholders.

Skills

Small molecule manufacturing

Technology transfer

Cross-functional leadership

English proficiency

Education

Degree in natural science/chemistry or related

Job description

Title: Senior MS&T Specialist

Company: Ipsen Biopharm Ltd

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company's success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram .

Job Description:

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.