Job Opportunity:
This position involves leading or participating in projects focused on developing strategies for the chemistry, manufacturing, and controls (CMC) of combination drug devices.
Responsibilities include maintaining expertise in FDA, USP, and/or EP guidelines related to CMC regulatory topics, providing oversight in the development of CMC strategies, reviewing data and reports for accuracy and consistency, and collaborating with stakeholders to identify contract manufacturers and API vendors.
The ideal candidate will have a Bachelor's degree, Master's or PhD in engineering/science or a related field, a minimum of three years' experience in CMC, strong knowledge of medical device quality standards ISO13485/FDA practices and GMP, GLP or similar regulated industry standards, and familiarity with statistical methods and analysis.
Key Responsibilities
* Maintaining high level of expertise in FDA, USP and/or EP guidelines related to CMC regulatory topics.
* Providing oversight in the development of CMC strategies.
* Technically reviewing data and reports for accuracy and consistency.
* Collaborating with stakeholders to identify contract manufacturers and API vendors.
Qualifications
* Bachelor's degree, Master's or PhD in engineering/science or a related field.
* A minimum of three years' experience in CMC.
* Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP, GLP or similar regulated industry standards.
* Familiarity with statistical methods and analysis.
We are looking for an individual who is highly knowledgeable in CMC regulatory topics and has strong leadership skills. The ideal candidate will be able to work effectively in a team environment and communicate complex information clearly.