- This contractor will execute multiple projects and priorities at the same time. Examples of activities include:
- performing risk assessments for raw material changes and managing implementation of changes to suppliers,
- revise master manufacturing instructions,
- design changes to the manufacturing process,
- author and implement change controls to manufacturing processes,
- provide general support and troubleshooting for resolution of manufacturing process and technology issues, and author technical reports.
- There is some potential to support cleaning validation processes.
- We need the following qualifications and experience:
- BS degree in Science, Pharmacy, Engineering or related discipline, with a minimum of 5 years’ experience in cGMP production manufacturing
- experience in implementing changes to raw materials
- experience in developing and implementing changes to commercial manufacturing processes (dry powder and/or sachet packaging is ideal)