Senior Analytical Scientist

2 days ago

Macclesfield, United Kingdom CK Group Full time
Senior Analytical Scientist Role

We are seeking an experienced Senior Analytical Scientist to lead analytical development activities in support of drug product development and supply during early clinical phases.

  • Develop and implement analytical methodologies to drive project progression through early development.
  • Conduct lab-based experimental work to generate data for project progression, adhering to Good Manufacturing Practice where necessary.
  • Author relevant sections of regulatory submissions and prepare responses to regulatory inquiries.
  • Interpret analytical data to inform reliable conclusions and recommendations influencing project progression.
  • Establish risk assessments and stability/control strategies ensuring safe and efficacious drug product delivery.
Your Background
  • BSc, MSc, PhD, or equivalent degree in Chemistry or Analytical Chemistry.
  • Understanding of analytical science inputs into early phase drug product development and clinical supply.
  • Experience with analytical techniques used to characterise drug products in early phase development and for clinical supply.
  • Background in the pharmaceutical or similar research/manufacturing industry.
  • Experience authoring CMC content for analytical aspects of drug product regulatory filings (desired).
About the Company

Our client is a global research-based bio-pharmaceutical company committed to making a meaningful impact on people's lives with life-changing medicines.

Location

This role is based at our client's Macclesfield site.

Key Information
  • Salary: £26.00 per hour PAYE or £50.68 per hour Umbrella – inside IR35.
  • Contract length: 12 months.
  • Entitlement to work in the UK required.
  • Subject to basic Disclosure and Barring Service (DBS) check.

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