Job Title: Chemist
Job Summary
We are seeking a skilled Chemist to join our team in Limerick. The primary function of this position is to lead and/or participate in projects focused on developing strategy with respect to chemistry, manufacturing, and controls (CMC) of combination drug devices.
Key Responsibilities:
* Maintain high level of expertise in FDA, US Pharmacopeia and/or European Pharmacopeia and ICH guidelines related to CMC regulatory topics.
* 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.
* Lead or participate in engineering projects serving as subject matter expert within the field of CMC and test method development.
* Provide input on new product introduction and assessing proposed manufacturing changes.
* Support the Investigation / Root Cause Analysis of OOS API results.
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.
* Familiarity with statistical methods, analysis, and interpretation.