Scientific Leader in CMC Development

2 weeks ago

Limerick, Limerick, Ireland beBeeProcessChemist Full time €65,432 - €123,456

Role Overview:

As a Process Chemist, you will play a critical role in leading and participating in projects focused on developing strategies with respect to chemistry, manufacturing, and controls (CMC) of combination drug devices.

Key Responsibilities:
  • Lead or participate in engineering projects serving as subject matter expert within the field of CMC and test method development.
  • Provide oversight in the development of CMC strategies to support global regulatory strategy and submissions.
  • Technically review data and reports for accuracy and consistency with regulator's expectations.
  • Collaborate with stakeholders to identify contract manufacturers, API vendor selection, qualification and support audits of same.
  • Support the Investigation / Root Cause Analysis of OOS API results ensuring consistency in terms of methodology and regulatory expectations.

For this position, we require a Bachelor's degree, Masters or PhD in engineering/science or a related field, with minimum 3 years' relevant experience with CMC. Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP, GLP or similar regulated industry standards is also required.

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