A BDN client is looking for a consultant who is experienced in method development and validation for gene therapy product release assays. These would require residual DNA measurement using quantitative PCR, residual protein and total protein measurement by ELISA, and several other assays. This candidate needs to have a Viral Vector, DNA, Cell Development experience with ELISA Assay experience for doing the method development and Validation. He/she will need to design the testing, identify detection limits, feasibility, etc. They will also be writing the protocols for testing and validation. They will have to have some experience in Instrument Qualification to be able to Validate the methods. The individual must be senior level and is able to come in and drive the Method Development and Validation.
