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 thedelivery of drug substanceof the right qualitywith 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 robustdrug substancecrystallisation/precipitation &isolation and dryingprocesses.Youwill workcollaborativelywith multiple internal and external partners,including drug substance and drug product colleagues andContract 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 acrossthe development and Large-Scale Laboratory for GMP manufacture of drug substance.Itwill also involveadvisingour development teams and our Contract Development and Manufacturing Organisations (CDMOs).

• Develop new crystallisation(or precipitation),isolationand dryingprocesses foractive pharmaceutical ingredients (API),to meet specifications(e.g.chemicalpurity),solidformand particle property requirements.
• Provideexpert advice to drug substanceprocessdevelopment scientistson development of crystallisation,isolation& dryingprocesses as an integralpart of synthetic route development.
• Work collaboratively with colleagues inDrug Substance andDrug Product Development units to evaluate, influence and agree on solid formand particle properties for bioavailability and formulation activities.Represent own area of expertise with a large degree of independencewith a view to influencingoverall drug project direction.
• Assess, review and report data from own work, with a clear understanding of its reliability,and interpret findings anddrawauthoritative 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 ofcrystallisation processes.This will include overseeing themanufacturing of batches of pre-clinical or clinical materialin internal or external manufacturing facilities. 
• Ensure own work is performedin accordance withappropriate Safety, Health & Environment (SHE),qualityand compliance standards, e.g. Good Laboratory Practice (GLP)or Good Manufacturing Practice (GMP).
• Drivethe identification and implementation ofnew science and ways of working in own area of expertise.