Your new company

Your new role

• You will be the first point of contact for the analytical aspects of development and supply of drug products for use is early clinical studies.
• You will work with other skill areas such as formulation and solid state to ensure the appropriate characterisation is performed to influence the development of drug products.
• You will ensure high quality methodology is in place to characterise drug products and generate the high quality analytical data we need to progress projects.
• You will have the opportunity to work with scientists in other functions to drive science and innovation within drug projects; this will include collaboration with scientists at our Cambridge, Boston & Gothenburg sites.

What you'll need to succeed

• Lead the analytical development activities to support development and supply of drug product during the early clinical phases.
• Identify and develop the analytical methodologies that support project progression through early development.
• Conduct lab-based experimental work to generate data to support progression of your own and other projects.
• This will include compliance with Good Manufacturing Practice where appropriate.
• Interpret analytical data and draw reliable conclusions and recommendations to influence project progression.
• Develop the risk assessments and stability and control strategies that ensure our patients receive a safe and efficacious drug product.
• Author the relevant sections of regulatory submissions and prepare responses to regulatory questions.
• Work as a member of cross-functional teams, representing EPDM or an area of your expertise.
• Compliance with appropriate Safety, Health & Environment (SHE) and Quality (e.g. Good Manufacturing Practice , GMP)