We are seeking a Process Development Scientist 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.
1. Maintain high level of expertise in FDA, US Pharmacopeia and/or European Pharmacopeia and ICH guidelines related to CMC regulatory topics.
2. Provide oversight in the development of CMC strategies to support global regulatory strategy and submissions.
3. Technically review data and reports for accuracy and consistency with regulator's expectations.
4. Provide CMC expertise and collaborate with stakeholders to identify contract manufacturers and 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 and provide guidance during implementation of product changes.
7. Support the Investigation / Root Cause Analysis of OOS API results ensuring consistency in terms of methodology and regulatory expectations.
8. Collaborate with other Post Market / Manufacturing Engineering Teams to ensure the effective completion of all activities associated with Post Market Engineering projects / objectives.
The ideal candidate will have a Bachelor's degree in engineering/science or a related field, 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.
This role offers good flexibility in terms of onsite requirement due to our hybrid working model.