MS&T Analytical Manager

at  Ipsen Biopharm Ltd

Ipsen is a fast-growing biopharmaceutical group specialising in the development of innovative medicines in oncology, neuroscience, and rare diseases. Our goal is to improve the quality of life of patients through the search for new solutions to targeted disabling diseases.
The External Manufacturing network has become a critically important part of Ipsen’s specialty care business due to a number of recent strategic acquisitions where products are supplied from Contract Manufacturing Organisations (CMOs).
The MS&T Analytical Manager will be responsible for ensuring timely delivery of end-to-end analytical activities related to oral solid dose products, this encompasses method development, validation, transfer, statistical analysis, and data visualisation aligning with global regulatory guidelines for product submission and GMP requirements for routine commercial manufacture.
The role involves close collaboration with cross-functional teams, including R&D, Quality, and regulatory affairs. Additionally, the individual must establish and maintain strong technical relationships with CMOs worldwide. Coaching team members with limited analytical knowledge and managing a diverse range of projects as well as managing own projects is required and therefore strong prioritization and project management skills is expected.
Whilst the analytical expertise is the core requirement, the scope of role may extend to manage all technical activities including drug substance and drug product manufacture for a given product/project.

EDUCATION / CERTIFICATIONS:

• Degree level (or higher) in natural science or similar

EXPERIENCE REQUIRED:

• Oral Solid Dose (OSD) product development and manufacture phases including phase 3 and launch to market
• Understanding of regulatory dossier requirement and ability to respond to questions.
• Project management and technical leadership
• Ability to lead cross functional groups as well as being a team member
• Quality by design
• Technology transfer, new product introduction

EXPERIENCE PREFERRED:

• Experience working with or at a CMO or CDMO
• Broad knowledge of OSD Formulation/process Development