Job Summary

A health information management company is filling a position for a Virtual Analytical Sciences Director.

Must be able to:

• Establish the approach to assay qualification and validation
• Provide oversight of analytical method development

Position Requirements Include:

• Has contributed as a SME to regulatory filings of parenteral BioPharmaceutical products
• Degree in science, with 15 years working in a BioPharmaceutical setting in an analytical environment at increasing levels of responsibility
• Experience of protein biochemistry and immuno-assays for the control of parenteral products either directly or by using CMO’s
• Experience of Regulatory inspection of contract testing facilities (preferably an FDA PLI)
• Proven ability to champion new approaches within a rapidly growing environment