Perform analytical testing within expected timelines. Provide peer review of data obtained for compliance in accordance with specifications and report abnormalities to supervision. Assist with laboratory investigations.
Root cause analysis of a wide variety of failures related to issues arising in development, manufacturing or use of products in a variety of industries including consumer products, medical device, pharmaceuticals, and other markets.
Schedule, prepare and analyze samples based on method requirements within turnaround time (TAT) established by Department Manager, Team Leader or Lab Coordinator. Inform Team Leader or Lab Coordinator if issues arise that effect the TAT.
Perform routine analytical tests of pharmaceutical raw materials, in-process samples, blends, finished products, and stability samples using instrumentation such as HPLC, UPLC, GC, UV/VIS, FTIR, dissolution apparatus, particle size analyze, etc.
Candidate will develop and validate analytical methods, maintain and calibrate all analytical lab equipments, write and review Standard Operating Analytical Test Methods, SOP, and validation protocols.
Support test method transfer and validation of assays such as UV-VIS Spectrometry, SDS Page, Wet chemical analysis, utility testing (e.g. TOC, conductivity, and gas testing) and more complex assays including GC solvent analysis, various HPLC methodologies (e.g. peptide map and carbohydrate analysis,) ELISAs, qPCR and bioassay.
Conducts research, analysis, synthesis, and experimentation on raw materials, finished products, competitive products, and field samples. Results are reported in a clear, accurate, concise manner, in written and electronic formats.