WebGyrolab™ xP control software is 21 CFR part 11 compliant and the manufacture validates instrument perfor-mance at install. Additionally, annual and routine preventive … WebPrior work with quantitative LC/MS-based bioanalysis of therapeutic peptides, small molecules, ADCs, and proteins. Experience with scientific publications and presentations at scientific meetings. Knowledge of the drug development process. Proficiency in various databases and data processing software including Sciex Analyst ©, and Watson ©.
Holly Stefl - Chief Commercial Officer - Agilex Biolabs Pty Ltd
WebDiscovery and Nonregulated Solutions for DMPK. Inotiv offers a broad scope of expertise for drug metabolism and pharmacokinetics (DMPK) studies at all stages of R&D, from lead optimization through new drug application (NDA). Benefit from our long and impeccable regulatory history, world-class team of scientists, and 40+ year track record of ... WebApr 11, 2024 · To run on a day to day basis and report, studies of various types and complexity.As a Lead Scientist Bioanalysis your main responsibilities will be:Direct the successful commencement, running, completion, and reporting of studies assigned to youLiaise with internal and external customers to ensure prompt and proper action on all … sas framont boufferet
Regulated Bioanalytical Laboratories - Google Books
WebNov 16, 2010 · Readers learn how to develop and implement strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process. The book also gives guidelines on qualification of certified standards and in-house reference material as well as on people qualification. WebAccomplished Scientist and industry leader with end-to-end knowledge of the drug discovery and development process, from lead generation to preclinical, early phase clinical and late phase clinical trials. Over the past 25 years I have worked across Biotechnology, Molecular and Cellular Biology, Immunology and Regulated Bioanalysis. My experience extends … WebReaders learn how to develop and implement strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process. The book also gives guidelines on qualification of certified standards and in-house reference material as well as on people qualification. sas francklin-aspireflex