Analytical Scientist

2 weeks ago


Cork, Cork, Ireland beBee Careers Full time
Technical Expertise - Scientist Role

The ideal candidate will have a strong understanding of analytical techniques and be able to apply this knowledge to support the development and implementation of phase-appropriate analytical control strategies.

  • Lead the development of control system strategies for new and existing products, ensuring compliance with Health Authority and pharmacopeia requirements.
  • Accountable for product characterization strategy, responsible for sampling & testing plans aligned with analytical control strategy, and oversight of the control system strategy.
  • Collaborate with key stakeholders in the review of proposed stability plans, data sets, etc. for filings to ensure consistency and identify trends that drive method requirements.
  • Author documentation summarizing reportable changes to analytical methods, supporting the authoring and review of the CTD Module 3 DS and DP sections for INDs, IMPDs, BLAs, MAAs etc.


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