Job Description:
We are seeking a highly skilled Chemist to join our team in Limerick.
Main Responsibilities:
1. Maintain expertise in FDA, US Pharmacopeia and/or European Pharmacopeia and ICH guidelines related to CMC regulatory topics.
2. Develop CMC strategies to support global regulatory strategy and submissions.
3. Review data and reports for accuracy and consistency with regulator's expectations.
4. Collaborate with stakeholders to identify contract manufacturers, API vendor selection, qualification, and support audits of same.
5. Lead or participate in engineering projects serving as subject matter expert within the field of CMC and test method development.
6. Provide input on new product introduction and assessing proposed manufacturing changes.
7. Support the Investigation / Root Cause Analysis of OOS API results.
8. Collaborate with other Post Market / Manufacturing Engineering Teams to ensure effective completion of all activities associated with Post Market Engineering projects / objectives.
Requirements:
* 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.
* Proven analytical and problem-solving skills.
* Strong interpersonal skills and the ability to communicate across functions.