Description:
•\tActive Pharmaceutical Sirolimus – active ingredient needs knowledge of regulatory landscape on this.
•\tThis person will be the go to for regulatory and chemistry questions for Sirolimus (really needs to know it vs going out to research it)
•\tSomeone who the FDA comes up, knows how to push back. Needs someone who can have answers within a few hours vs coming back a few days later
•\tKnow Stability testing
•\tIndividual will go through out of specification report (OOS) results and review them for content and make decisions as needed.
•\tWill help implement LIMS system
•\tAssisting in method transfer of developed methods in routine testing lab. Can provide help with this on the side.
•\tExperience with Deep domain sirolimus invitro experience - HPLC and Elution
Expert Level
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