CK Group are recruiting for an experienced Analytical Development 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.
Your Background:
* 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 HPLC/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.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 120 653 in all correspondence.
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