Analytical Scientist
Current• Everlasting and continuous endeavors for the advancement of GMP and Clinical grade SgRNA to match the FDA requirements through Mass Spectrometry method development.• HPLC method development with GMP validation protocol and integration parameters.• Leading the Analytical Chemistry meeting to discuss, share, and present various analytical chemistry problems and projects.• Bringing up all the analytical instruments in Factory 2, their installation, method validation, and release.• All responsibilities covered in the Mass Spectrometry Engineer role.• Collaborated closely with QC and QA teams to maintain instrument qualification from onboarding to every repair. Implemented developed methods in the GMP facility, involving the creation of SOPs, Change Control, URS, and various quality documents.• Engaged with customers as a subject matter expert in MS and HPLC, collaborated with the data and software team on diverse requirements, identified and resolved production-related issues for seamless factory operations, led discussions, and coordinated weekly analytical chemistry meetings. Worked closely with the QC team to ensure quality data and managed a team with one subordinate.