Analyst from Genzyme in pharmaceutical analytical laboratory performing many analytical techniques with regard to natural materials, API along with completed product. Method verification, move and also validation.
Past practical experience when analyst for a chromatography group inside Analytical Services with Par Pharmaceuticals.
Past practical knowledge because analyst for just a chromatography class within Analytical Quality Sciences department at Wyeth along with eighteen years of experience.
Experience with: - cGMP analysis of pharmaceutical drug components by way of various chromatography strategies like GC, HPLC, GC/MS, dissolution, TLC, along with KF. Support of plans through pre-IND to help NDA submission. - Specifications and investigation of drug materials based on USP and ICH guidelines - Coordinating method qualification/validation projects regarding Regulatory Submissions. - Coordinating technique technical transfers to be able to bodily web sites plus contract laboratories.
Project team supervision to get in-house meds compound. Duties are to help stand for analytical at crew meetings, posting plus release associated with examples associated with this kind of project in addition to representing analytical data from inside project evaluate meetings.
SpecialtiesSpecialties pick up while in the preceding expertise in addition to goals section.
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