Senior Chemist

We are seeking a skilled Process Development Specialist to join our team in Limerick. This role focuses on process and problem-solving, with opportunities for flexible working arrangements.

• Develop and maintain expertise in regulatory guidelines related to chemistry, manufacturing, and controls (CMC) topics.
• Promote the development of CMC strategies to support global regulatory submissions and provide technical review of 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 audit support.
• Lead or participate in engineering projects as a subject matter expert within the field of CMC and test method development.

• Evaluate proposed manufacturing changes and provide guidance during implementation.
• Support the investigation/root cause analysis of out-of-specification (OOS) API results ensuring consistency in methodology and regulatory expectations.
• Collaborate with Post Market/Manufacturing Engineering Teams to ensure effective completion of activities associated with Post Market Engineering projects/objectives.

Qualifications / Requirements:
A bachelor's degree, master's, or PhD in engineering/science or a related field.
Minimum 3 years' experience with CMC, knowledge of medical device quality standards, and familiarity with FDA, US Pharmacopeia, and/or European Pharmacopeia and ICH CMC regulatory topics.