Principle Scientist

We are excited to announce a new Principal Scientist position within our Biologics development team. This is a permanent position preferably based at our Wrexham site, however there is potential to be based at either our Paddington or Dublin offices, offering hybrid working.

As the successful candidate you’ll lead all aspects of Drug Substance development, tech transfer, validation, and regulatory submission for Biologics drug substance. You’ll provide strategic and technical input into drug substance development and manufacturing technologies and lead cross-functional teams responsible for delivering both CMC development programs and internal process improvement programs. Additionally, this position involves future-proofing Ipsen processes by incorporating a sustainability-by-design approach to manufacturing process development. The successful candidate you’ll help lead and implement these new processes to ensure Ipsen's continued success and innovation in the field of Biologics.

This is a fantastic opportunity for a seasoned professional to make a significant impact while working on an exciting and varied role!

Role Responsibilities

• Lead, design, and execute research activities within GxP and other applicable requirements aligned with the Research & Development pipeline.
• Demonstrate advanced knowledge of industry trends, practices, and standards.
• Plan and oversee complex experiments/series of experiments, collate and analyze data, and write comprehensive technical reports.Apply advanced process control testing strategies using Quality by Design/DoE approaches to improve understanding of process limits/design space within processes.ead and manage aspects of process transfer, validation, and process lifecycle management.
• Contribute to and review regulatory documentation.
• Ensure compliance with GxP/EHS requirements.
• Promote and support intra- and inter-site cross-functional interactions, including external contracts.
• Lead and contribute within cross-functional teams at the departmental and organizational levels to progress Ipsen’s biologics pipeline.
• Initiate and coordinate other site functions to support Ipsen’s biologics pipeline requirements.
• Initiate and manage collaborations with third parties to progress Biologics Development activities, including review of proposals, protocols, and reports.
• Provide expert guidance and troubleshoot complex technical issues and bottlenecks across all projects under scope.
• Train, mentor, and lead teams on new processes and technologies.

• Lead the design and optimization of biologics drug substance manufacturing processes to minimize environmental impact, including reducing waste, energy consumption, and the use of hazardous materials utilising Sustainability by Design principles.
• Implement Sustainability by Design frameworks to minimise environmental impacts.
• Develop tools to evaluate the impact of development decisions on product sustainability.
• Identify opportunities for circularity in Drug Substance manufacturing.
• Identify technologies that improve the sustainability of manufacturing processes – process intensification.
  

Knowledge & Experience (essential)

• Degree or equivalent qualification in relevant subject.
• Extensive experience in the development of mammalian expressed biologics.
• Experience in authoring regulatory documentation.
• Demonstrated breadth of understanding of all aspects of CMC development throughout product lifecycle
  
  

Knowledge & Experience (preferred)

• PhD or equivalent in relevant subject.
• Operational Excellence certification.
• Knowledge of applying Life Cycle Assessments to Biologics manufacturing processes.
• Knowledge and experience of applying Operational Excellence to development processes (Yellow/Green belt).
  
  

Join Our Award-Winning Team at Ipsen Wrexham

At Ipsen, we are committed to improving the lives of patients, with a special focus on advancing neuroscience therapies. Our Wrexham site is a vital part of this mission, delivering cutting-edge solutions in a dynamic and collaborative environment. We are proud to be Great Place to Work certified and a Shingo Bronze Medallion holder, reflecting our commitment to excellence, innovation, and continuous improvement.

With a recent £24 million investment in the site and a further £86.4 million expansion underway, there has never been a more exciting time to join us. If you are passionate about making an impact and want to be part of a team that values growth, innovation, and excellence, then Ipsen could be where you thrive!