Job Summary
This is a strategic role focused on process and problem solving, with a high level of expertise in FDA, US Pharmacopeia, and ICH guidelines related to Chemistry, Manufacturing, and Controls (CMC) regulatory topics. The Chemist will lead and/or participate in projects developing CMC strategies to support global regulatory strategy and submissions.
Main Responsibilities:
* Maintain high level of expertise in FDA, US Pharmacopeia, and European Pharmacopeia, and ICH guidelines related to CMC regulatory topics.
* Develop and provide oversight in CMC strategies to support global regulatory strategy and submissions.
* Review data and reports for accuracy and consistency with regulators' 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 as a subject matter expert within the field of CMC and test method development.
* Assess proposed manufacturing changes and provide guidance during implementation of product changes.
* Support 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 effective completion of all activities associated with Post-Market Engineering projects/objectives.
* Interact effectively with internal companies and global functions within the organisation to develop and implement CMC strategies.
Requirements:
* Bachelor's degree, Masters, or PhD in engineering/science or 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.
* Familiarity with FDA, US Pharmacopeia, and/or European Pharmacopeia and ICH CMC regulatory topics.
* Proven analytical and problem-solving skills.
* Strong interpersonal skills and 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.