Process Chemist
We are seeking a skilled Process Chemist to join our team in a strategic role focused on process and problem-solving.
Main Responsibilities:
* Maintain expertise in FDA, US Pharmacopeia, and ICH guidelines related to CMC regulatory topics.
* Develop and review data and reports for accuracy and consistency with regulator's expectations.
* Provide CMC expertise and collaborate with stakeholders to identify contract manufacturers and API vendors.
* Lead or participate in engineering projects serving as subject matter expert within the field of CMC and test method development.
* Support the Investigation / Root Cause Analysis of OOS API results ensuring consistency in terms of methodology and regulatory expectations.
* Collaborate with Post Market / Manufacturing Engineering Teams to ensure effective completion of activities associated with Post Market Engineering projects / objectives.
Key Qualifications:
* Bachelor's degree, Masters or PhD is required, preferably in engineering/science or a related field.
* Minimum of 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.