Senior Scientist, Drug Product

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!

We’re currently seeking a Senior Scientist to join the team on a 12-month fixed-term contract. This position allows you to lead and execute process optimization projects, driving improvements in manufacturing process performance and efficiency. By utilizing your scientific expertise and knowledge, you will develop strategies for capacity and yield maximization, ensuring the successful technology transfer and new product introduction from development to commercial manufacturing.

If you are passionate about advancing drug product manufacturing processes, eager to work on cutting-edge studies and investigations, and excited to collaborate with various departments on exciting projects, then this position could be perfect for you!

Responsibilities

• To lead and execute process optimisation projects to improve manufacturing process performance.
• To utilise scientific principles, process, and product knowledge to drive and develop strategies for capacity and yield maximisation within production areas.
• Responsible for the Technology transfer and New product introduction of Drug product process from Development into commercial manufacturing facilities.
• Design and execution of process optimisation, Scalability, Investigation studies within manufacturing areas to increase process efficiency in Formulation, Filling, Lyophilisation, Capping, Sterile Filtration, Isolator technology etc.
• Have a broad understanding of CMC activities, understand risks and be able to link actions to Manufacturing Science and Technology
• Understands and independently leads activities related to departmental/site objectives and project milestones. Presenting the ideas and project plans to stake holders including Site Leadership team and global MS&T team
• Able to perform technical/critical review of data from sterile manufacturing process including Lyophilisation, formulation, VHP etc.
• Lead and execute E&L Studies, Filter adsorption studies, TSE/BSE Assessment, single use compatibility studies, Container closure integrity studies etc.
• Lead process monitoring and data gathering & analysis of the Production facility (including execution of the CPV programme). Proactively and reactively looking for areas of improvement.
• Train, coach and mentor production staff during project implementation and root cause investigations.
• Work with wider production department to prepare, review and edit relevant documentation – SOPs, Training Packages, Protocols, Reports etc.
• To develop as a SME in Drug Product manufacturing process, Lyophilisation, VHP, Sterilisation, Aseptic Techniques, Isolators, Media simulation etc. and lead these processes and the development of new methods to support process improvement activities.
• Supervise and mentor industrial placements, interns and work experience students.
• Actively assess emerging techniques in the field of formulation either internally or via external collaboration.
  
  

GMP / EHS Requirements

• To perform assigned tasks in accordance with current GxP requirements
• Report any compliance concerns to your line-manager or Quality Assurance Compliance.
• Independently leads safety initiatives and improvements
• To always work in a safe manner and raise any Health and Safety concerns to your line-manager or the Health and Safety team.
• Ensure appropriately trained in the most up to date policy/procedure prior to carrying out any task
• Ensure all training is kept up to date and documented by adhering to training plan requirements.
  
  

Essential Requirements

• Degree level qualified in scientific, pharmaceutical or engineering discipline
• Proven industry experience within a pharmaceutical or sterile manufacturing environment
• Good knowledge and understanding in Sterile Manufacturing of medicinal Drug products
• Good knowledge in Data analysis of production data, Data visualisation, utilisation of statistical tools such as JMP, Minitab etc.
• Good knowledge in Lyophilisation, Aseptic filling, Isolator technology, Process simulations/Media fills, drug product formulation and sterilisation techniques (Moist heat, Dry heat etc.)
• Good understanding of biologics process development, stability studies, product hold times, filtration studies, scaleup studies, Extractable & Leachable etc.
• Good knowledge in Technology transfer, New product Introduction, Facility fit, Gap analysis,
• Equipment compatibility assessment, engineering studies etc.
• Leading of technical projects, managing stake holders, conflict resolution etc.
  
  

Preferred

• MSc or PhD in Scientific, Pharmaceutical or Engineering discipline
• Good Knowledge in Biologics process development and Production is essential. Understanding in Toxin development and manufacturing is desirable.
• Working knowledge in performing Product impact assessment, Risk assessment, FMEAs etc. Understanding of supplier management, for example, lead time and change notifications.