Job Title: Chemist
We are seeking a highly skilled Chemist to join our team in Limerick.
This is a strategic, desk-based role with a strong focus on process and problem-solving. You will be responsible for leading and participating in projects focused on developing strategy with respect to chemistry, manufacturing, and controls (CMC) of combination drug devices.
Key Responsibilities:
* Maintain high-level 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.
* Provide CMC expertise and 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 and provide guidance during implementation of product changes.
* Suport the Investigation / Root Cause Analysis of OOS API results ensuring consistency in terms of methodology and regulatory expectations.
* Collaborate with other Post Market / Manufacturing Engineering Teams to ensure the effective completion of all activities associated with Post Market Engineering projects / objectives.
* Collaborate and interact effectively with other internal companies and global functions within the organisation to develop and implement CMC strategies.
* Ensure effective reporting to the Post Market Engineering management team.
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.
* Ability to work on multiple projects, organize, and prioritize within time constraints.
* Familiarity with Microsoft Office software.
* High self-motivation.
* Willingsness and availability to travel on company business.