Address
Form of workTo support the methods development and validation to test new products manufactured at the site.
- Participate in the transfer of analytical technology to the commercial laboratories.
- Perform compendial test verifications under minimum supervision and prepare summaries of experimental trials.
- Interpret results obtained during method development and troubleshoot tests as needed. Prepared and Execute analytical and cleaning methods validation protocols and summarize results validation report.
Requirements
- 10 years or more of experience in a cGMP regulated Analytical Laboratory, and previous participation in method development, validation execution and analytical technology transfer is required.
- Knowledge in FDA,WHO, USP and ICH guidelines for method development and validation is required.
- BS in Chemistry or higher is required.
