Job Summary

A company that researches food allergies has an open position for a Remote Food Allergies Analytical Development Principal Scientist.

Must be able to:

• Manage the development of analytical methods and subsequent validations with CTLs and CMOs
• Oversee quality control and stability testing of the product at CTLs and/or CMOs
• Provide content and author for sections related to analytical methods, product specifications, etc

Qualifications Include:

• B.S. degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field
• 15 years relevant experience in analytical development and/or quality control in pharmaceutical setting
• Experience in the development and validation of enzyme activity assays for oral biologics
• Knowledge and hands-on experience with GxP dissolution method development and testing.
• Familiarity with USP [General Chapter ⟨711⟩], EP, US FDA, and SUPAC guidelines
• Ability to design and perform in-vitro comparative dissolution experiments