A new experienced chemist with working in a drug/biotherapeutics industry. Well-versed in Current Good Manufacturing Practice (CGMP), standard operating procedures of pharmaceutical staging, U.S. Food and Drug Administration policy and public health maintenance. Determined research professional with a bachelor’s degree in Chemistry. With regards to strengths, emphasizing the ability to collaborate efficiently with a team through consistent communication, carefully analyze figures, detect root causes of design flaws and devise a plan to rectify them. With creating realistic goals then prioritize them to ensure a steady workflow, wherein veracity, diligence and a drive to improve lives are held in the highest regard. Preferably seeking employment in a research and development or analytical setting in the pharmaceutical industry.
· Aid in development of new chemical entities (NCEs), involving pilot scale purification of plasma derived glycoprotein for pre-clinical toxicity and GMP Phase 1-3 first-in-human clinical trials via ÄKTAprocess systems and corresponding UNICORN software
· Execute required assays, via compliant methods, of in-process intermediates, raw reagents and column volume stability tests (ELISA, Bradford, SoloVPE slope spectroscopy)
· Interpret results of desired final eluate from mechanisms such as hydrophobic interaction, immobilized metal affinity and ion-exchange, as well as depth filtration, tangential flow filtration and ultra-filtration/diafiltration, in addition to troubleshooting. Application of fast protein liquid chromatography to separate macromolecules based on size, ensuring preservation of complex structure
· Maintain accurate, complete, legible and concurrent directory of approved framework performed in GMP, GLP and GSP environment. Enforcement of data adhesion with LIMS
· Author department methods and edit MPRs for phrasing and formatting consistency
· Support Quality Assurance with deviation investigations, as well as Process Development with downscaling and filter integrity studies
· Proficient in bioburden and endotoxin sampling and conducting limulus amebocyte lysate (LAL) assessments and with VireSolve Pro Solution