MS&T Analytical Manager

Title:

MS&T Analytical Manager

Company:

Ipsen Biopharm Ltd

Job Description:

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.

Key duties and role expectations include:

Method Development, Validation and transfer:

• Authoring and reviewing documentation related to analytical method development, validation, and transfer.

• Ensuring compliance with regulatory requirements for both products and raw materials.

Manufacturing Science and Technology-Analytical activities:

• Collaborating with R&D teams and external partners to ensure analytical methods are suitable for production.

• Troubleshooting and optimizing analytical processes to improve product quality and efficiency.

• Leading effective investigations

Regulatory Submissions:

• Coordinating with regulatory affairs teams to prepare and submit analytical sections for regulatory filings.

• Ensuring compliance with guidelines from regulatory agencies (such as the FDA, EMA, or MHRA).

Project Management:

• Leading analytical projects, coordinating timelines, and ensuring deliverables are met.

• Collaborating with cross-functional teams (such as R&D, manufacturing, and quality) to align analytical activities with project goals.

Prioritization:

• Assessing the urgency and importance of different tasks and projects

Coaching and Mentorship:

• Providing guidance and mentorship to other members of the team

• Fostering a positive work environment, encouraging skill development, and promoting professional growth

Statistical Analysis and Data Visualisation:

• Applying statistical methods to analyze analytical data, assess method performance, and ensure robustness.

• Conducting hypothesis testing, ANOVA, regression analysis, and other relevant statistical techniques.

• Creating clear and informative visual representations of analytical results.

Collaboration with External Partners:

• Coordinating activities with contract research organizations (CROs) or external testing facilities.

• Building technical relationship

Knowledge, abilities & experience

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

Languages:

• English at a professional level. Understanding of French would be beneficial

Key Technical Competencies Required

• Extensive knowledge and experience with method development and Interpretation of analytical data particular dissolution to define specifications, influence /shape formulation/process development and quality control, Extensive experience with assessing discriminatory power of dissolution method

• Strong leadership

• Oral Solid Dose analytical validation, transfer/new product introduction and investigations

• Ability to build strong technical relationships

• Working understanding of pharmaceutical quality regulations (cGMP)

• Risk Analysis & Troubleshooting

• Data interpretation & Statistics

If you can point to an appropriate qualification as well as relevant experience, we would be delighted to engage with your application.

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IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.