Senior Analytical Scientist
Macclesfield
Science & Technology
Annual
Permanent
CK Group are recruiting for a Senior Analytical Scientist, to join a company in the pharmaceutical industry, based in Macclesfield, on a contract basis for 12 months.Salary: Hourly: £26.00 PAYE or £50.68 Umbrella this role is inside IR35. Senior Analytical Scientist Role:
- 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.
- Author the relevant sections of regulatory submissions and prepare responses to regulatory questions.
- 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.
- A BSc, MSc, PhD or equivalent in Chemistry or Analytical Chemistry.
- An understanding of analytical science inputs into early phase drug product development and clinical supply (for example risk assessment, stability strategy, control strategy).
- An understanding of analytical techniques used to characterise drug products in early phase development and for clinical supply.
- Experience in the pharmaceutical or similar research or manufacturing industry.
- Experience of authoring CMC content for the analytical aspects of drug product regulatory filings (desirable).
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