Chemistry Expert for Pharmaceutical Development
Our company is seeking a Chemistry Expert to join their team in Limerick. The role will involve leading and participating in projects focused on developing strategy with respect to chemistry, manufacturing, and controls (CMC) of combination drug devices.
Key Responsibilities:
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 and Support submissions pertinent to CMC for global regulators.
3. Technically review data and reports for accuracy and consistency with regulator's expectations including stability data and lot release data such as HPLC Particulate Dissolution.
4. Provide CMC expertise and 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 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.
9. Collaborate and interact effectively with other internal companies and global functions within the organisation e.g Regulatory Affairs Engineering Operations (Manufacturing) and Quality to develop and implement CMC strategies.
10. Ensure effective reporting to the Post Market Engineering management team.
The ideal candidate will have a Bachelor's degree Master's or PhD in engineering/science or a related field with at least 3 years' relevant experience in CMC.
This is an exciting opportunity to work with a highly skilled team and contribute to the development of innovative products that improve people's lives.