Client needs a Senior Level Analytical Method Validation consultant with 10 – 15 years of experience to help the client get protocols and reports written to File a Gene Therapy BLA by the end of 2024. Will be working on optimizing their report templates, writing the Method Validation protocols, then gathering data as needed, and writing the Method Validation reports. The consultant will need to travel out to the CMO for the first 1-2 weeks, but the work can be done remotely after that, with the possibility of short term travel every month or so for a couple days.
- 10-15 years Analytical Method Validation
- Protocol & Report Writing expert
- Be able to do this work independently with no oversight
- In order: Gene Therapy (HUGE PLUS), Cell Therapy, Vaccines, Biologics
- Degree in Chemistry or similar field
Remote: QC/Analytical Method Validation (223932)