Job Description
Job DescriptionĀ
Provide support for new product formulation, process development, transfers into manufacturing, and continuous improvement of existing processes.
Area Of Responsibility
ā¢ Manage tasks at independent level and contribute to cross-functional project management teams
ā¢ Design experiments using Quality by Design principles, execute and author reports in support of:
ā¢ Formulation, aseptic filling and lyophilization development of new products
ā¢ Continuous improvement, troubleshooting and investigations of existing processes and products
ā¢ Process transfers into manufacturing
ā¢ Perform analytical testing in support of product development studies
ā¢ Prepare cGMP documents such as SOPs, batch records and protocols
ā¢ Design, execute and write technical reports to support FDA filings
ā¢ May direct the work of junior Process Development staff
ā¢ Other duties as assigned
Work Conditions:
ā¢ Office
ā¢ Lab