Senior Scientist - Crystallisation

Early Chemical Development (ECD) is a World-Class CMC department with responsibility for early phase Drug Substance. The department’s responsibilities span from early engagement with Discovery Chemistry groups to manufacture of Phase II Clinical material, and its key skill areas include Analytical Chemistry, Crystallisation, Isotope Chemistry, Large-Scale Laboratory (Kilo-Lab) Manufacturing, Process Chemistry, Process Design, Process Engineering, Route Design and Separation Science. 

In Early Chemical Development, an exciting opportunity has arisen for a Crystallisation Senior Scientist. 

You will be a key member of a team responsible for the delivery of drug substance of the right quality with a focus on physical attributes (solid form and particle properties) to clinical programs up to Phase II. You will bring a strong understanding of the design and development of robust drug substance crystallisation/precipitation  & isolation and drying processes. You will work collaboratively with multiple internal and external partners, including drug substance and drug product colleagues and Contract Development and Manufacturing Organisations (CDMOs). 

The role is based at the Macclesfield Campus, Cheshire. The role is primarily laboratory based and will involve working flexibly across the development and Large-Scale Laboratory for GMP manufacture of drug substance. It will also involve advising our development teams and our Contract Development and Manufacturing Organisations (CDMOs). 

• Develop new crystallisation (or precipitation), isolation and drying processes for active pharmaceutical ingredients (API), to meet specifications (e.g. chemical purity), solid form and particle property requirements. 
• Provide expert advice to drug substance process development scientists on development of crystallisation, isolation & drying processes as an integral part of synthetic route development. 
• Work collaboratively with colleagues in Drug Substance and Drug Product Development units to evaluate, influence and agree on solid form and particle properties for bioavailability and formulation activities. Represent own area of expertise with a large degree of independence with a view to influencing overall drug project direction.  
• Assess, review and report data from own work, with a clear understanding of its reliability, and interpret findings and draw authoritative conclusions and recommendations so that their significance can be appreciated.  
• Work collaboratively with internal and external manufacturing partners to ensure successful scale-up and scale-out of crystallisation processes. This will include overseeing the manufacturing of batches of pre-clinical or clinical material in internal or external manufacturing facilities.  
• Ensure own work is performed in accordance with appropriate Safety, Health & Environment (SHE), quality and compliance standards, e.g. Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP). 
• Drive the identification and implementation of new science and ways of working in own area of expertise.