Senior Scientist

3 days ago

United Kingdom SRG Full time

Key Responsibilities:

  • Current proven experience in leading the analytical development activities to support development and supply of drug product during the early clinical phases.
  • Current proven experience in Identifying and developing the analytical methodologies that support project progression through early development.
  • Current proven experience in Conducting 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.
  • Current proven experience in Interpreting analytical data and draw reliable conclusions and recommendations to influence project progression.
  • Current proven experience in developing the risk assessments and stability and control strategies that ensure our patients receive a safe and efficacious drug product.
  • Author the relevant sections of regulatory submissions and prepare responses to regulatory questions.
  • Work as a member of cross-functional teams, representing EPDM or an area of your expertise.
  • Current proven experience in Compliance with appropriate Safety, Health & Environment (SHE) and Quality (e.g. Good Manufacturing Practice , GMP standards.)

Essential Skills and Capabilities :

  • 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.
  • Excellent practical experimental skills.
  • An ability to apply scientific principles to problem solving.
  • An ability to develop new skills and learn new analytical techniques to support development activities.
  • A systematic approach to work and delivering to deadlines.
  • The ability to work with and through others.

Desired Skills and Capabilities :

  • Current proven experience in the pharmaceutical or similar research or manufacturing industry.
  • Skills and experience in key analytical techniques relevant to drug product analysis.
  • Current proven experience in the use of pharmacopeia dissolution systems, both automated (fully- and/or semi-automated) and manual, and in development of dissolution methods and their validation
  • Current proven experience in the use of UPLC systems and in the development of methods and their validation.
  • Pharmaceutical development project leadership, including planning of analytical activities.
  • Current proven experience in leading analytical activities to support manufacturing campaigns for drug product for internal and outsourced manufactures.
  • Scientific leadership skills with the ability to deliver robust scientific contributions to projects and demonstration of utilising risk based approaches for successful delivery.
  • Knowledge of and practical experience of implementing control strategies (quality by design or equivalent) to define the requirements for ensuring the quality of drug products.
  • Current proven experience of authoring CMC content for the analytical aspects of drug product regulatory filings.
  • Knowledge of and practical experience of quality and regulatory requirements (e.g. GMP and ICH), technology transfers and method validation.
  • Excellent communication skills with the ability to discuss complex ideas in a simple, easy to understand manner.

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