Chemical Process Developer

5 days ago


Limerick, Limerick, Ireland beBeeProcess Full time €85,000 - €125,000

Chemical Process Development Specialist

We are seeking an accomplished specialist to lead projects focused on strategy and execution of chemical manufacturing processes. The role requires providing oversight in method development and validation, specification/acceptance criterion development, stability testing, out-of-specification investigation, post-approval manufacturing changes, and verification of active pharmaceutical ingredient components.

This strategic role involves working closely with internal stakeholders to develop and implement comprehensive chemical process strategies. Key responsibilities include maintaining high-level expertise in relevant regulatory guidelines, reviewing data and reports for accuracy and consistency, and collaborating with contract manufacturers to ensure compliance.

Beyond these technical responsibilities, this position plays a vital role in driving organizational success through effective communication, collaboration, and problem-solving skills. The successful candidate will have the opportunity to work in a dynamic environment where they can apply their expertise and creativity to drive innovation and excellence.

  • Maintain high level of expertise in FDA, US Pharmacopeia and/or European Pharmacopeia and ICH guidelines related to CMC regulatory topics.
  • Develop and execute comprehensive chemical process strategies.
  • Provide technical review and oversight of data and reports.
  • Collaborate with contract manufacturers to ensure compliance.
  • Drive organizational success through effective communication, collaboration, and problem-solving skills.


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