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