CK Group are recruiting for an Analytical Scientist, to join a Contract Research & Development and Manufacturing Organisation (CRDMO), working with innovator biotech and pharmaceutical companies globally, who are based in Macclesfield, on a permanent basis.Company: This company is well established and growing with R&D facilities globally.Location: The role is based on site in Macclesfield, Cheshire.Role:

• Support chemistry projects, through analytical lab-based work, develop, validate and carry out technical transfer of analytical methods and release analysis (GMP and non-GMP).
• Developing, troubleshooting and validating analytical methods.
• Planning and executing analytical work to meet project timelines with minimal supervision.
• Working within multi-functional project teams operating to tight deadlines.
• Able to work effectively to GMP quality standards.
• Opportunity to lead the analytical aspects of projects and lead a team of analysts to plan, supervise and execute analytical work to meet project timelines.

• Educated to degree level or above in Chemistry, Analytical Chemistry or a related field.
• A background in Analytical Chemistry combined with demonstrated in-depth, hands-on expertise in LC/GC and experience of other analytical methodologies utilised to characterise APIs, intermediates and raw materials.
• Experience in other analytical methodologies such as techniques for identity or form determination (e.g. NMR, MS, IR, XRD).
• Understanding of GMP quality standards.
• Demonstrated analytical expertise supporting early, mid or late-phase route and process development of APIs, intermediates and raw materials.
• Experience in contracting analytical testing with third parties and leading communications with customers.
• Experience in regulatory requirements for the development and validation of LC/GC methods for content and the separation of impurities and degradation products in APIs including trace level analysis.
• Experience in out of specification and atypical result investigations.