Job Description:
Our client is currently looking to bring on a QC analytical consultant to help with qualifying analytical methods. The client is working on gene editing and needs someone with a QC and analytical method validation background who understands what a method qualification needs to entail in order for it to be successful. All testing is done by the team and this resource will be acting as the QC analyst. The client is pre-clinical and wants someone to have phase appropriate analytical method experience. The average day will consist of meeting with the analytical method development SME to understand how their methods are preformed. After that they will review the test methods with the SME, seek regulatory guidance to help design the method qualification and meet with the SME’s and team to evaluate accuracy. They will then author the protocol, send it for review and once it approved the analytical development team will execute the method. This resource will need to then assist in the data review to summarize it together in the qualification report, review the final test method and ensure it meets quality control standards. There are approximately 40 methods that currently need to be qualified by December.
Techniques:
Candidate must have experience in at least 3 of the following
qPCR, ddPCR or NGS
HPLC or LC-MS/MS
Bioassays or ELISA
Skills:
Quality Control
Analytical Method Validation
Plus:
Early phase and commercial experience
Stability experience
mRNA and Lipid Nanoparticle experience
Experience:
Bachelors degree and 7+ years of experience required
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