- Pharmaceutical Senior Business Analyst, Project Manager, and SME in Research Informatics, Research IT, Data Management and Operations supporting drug discovery research and medical device development
- 3+ years of industry experience as a Project Manager and Business Analyst
- Educational background in Biomedical Sciences, Engineering, Computer Science, and Management
- Information engineering, data management, process automation, robotic systems and analytics
- Research and development (R&D) systems: Laboratory Information Management System (LIMS), Electronic Laboratory Notebook (ELN), Chromatography Data System (CDS), Scientific Data Management System (SDMS), Clinical Trial Management System (CTMS), Adverse Event Reporting System (AERS), etc.
- Cloud - based (AWS) and on-premise solutions
- Scientific applications such as Benchling, IDBS, Biovia, Scilligence, Labvantage, Labware, Empower, Nugenesis, Watson, Scilligence, Genedata Screener, ActivityBase, Pipeline Pilot, D360, Vortex, Dotmatics, Nonmem, WinNonlin, Tableau, Nugenesis, Empower, OpenLab, Oracle Siebel, Argus Safety
- Project Management (PMBoK) and SDLC
- Data flow analysis, taxonomy and ontology development, data dictionary development, etc.
- GxP regulations (21 CFR, ICH, EudraLex, MHRA, etc.), ER/ES (21 CFR Part 11, EU Annex 11), Computer System Validation, and risk-based methodologies (e.g., GAMP5)
- Six Sigma, FMEA, Gap analysis, Remediation, etc.
Principal Business Analyst and Project Manager
- Research data curation, ontology management, data mining, analytics, and automation solutions for drug discovery research business processes (such as molecular biology, antibody engineering, compound management, bioassays, HTS, structural biology, computational biology, computational chemistry, medicinal chemistry, genomics, etc.) and their integration with ELN and LIMS
- Business analysis, UAT, user training, system operation, etc.