Chemical Process Lead

6 days ago


Limerick, Limerick, Ireland Cook Ireland Ltd Full time

Job Description

We are seeking an experienced Chemical Process Lead to join our team in Limerick. As a key member of our Post-Market Engineering team, you will be responsible for providing expert guidance on chemistry, manufacturing, and controls (CMC) strategies to support global regulatory submissions.

Responsibilities

  1. Lead and participate in engineering projects as a subject matter expert within the field of CMC and test method development.
  2. Provide technical review of data and reports for accuracy and consistency with regulator's expectations.
  3. Collaborate with stakeholders to identify contract manufacturers, API vendor selection, qualification, and support audits of same.
  4. Develop and implement CMC strategies to ensure compliance with FDA, US Pharmacopeia, and/or European Pharmacopeia and ICH guidelines.
  5. Maintain high level of expertise in relevant regulatory topics.


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