Advanced Chemical Process Specialist

5 days ago


Limerick, Limerick, Ireland beBeeProcessChemist Full time €60,000 - €100,000
Process Chemist

We are seeking a skilled Process Chemist to join our team in a strategic role focused on process and problem-solving.

Main Responsibilities:
  • Maintain expertise in FDA, US Pharmacopeia, and ICH guidelines related to CMC regulatory topics.
  • Develop and review data and reports for accuracy and consistency with regulator's expectations.
  • Provide CMC expertise and collaborate with stakeholders to identify contract manufacturers and API vendors.
  • Lead or participate in engineering projects serving as subject matter expert within the field of CMC and test method development.
  • Support the Investigation / Root Cause Analysis of OOS API results ensuring consistency in terms of methodology and regulatory expectations.
  • Collaborate with Post Market / Manufacturing Engineering Teams to ensure effective completion of activities associated with Post Market Engineering projects / objectives.
Key Qualifications:
  • Bachelor's degree, Masters or PhD is required, preferably in engineering/science or a related field.
  • Minimum of 3 years' relevant experience with CMC.
  • Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP, GLP or similar regulated industry standards.
  • Familiarity with FDA, US Pharmacopeia and/or European Pharmacopeia and ICH CMC regulatory topics.


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