Experience

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  Apotex inc.

  May 2015 - now

  • Formulating bioanalytical study sample analysis by LC-MS/MS in compliance with GLP documentation and guidelines.• Synchronizing with the team to develop & validate new analytical techniques for LC-MS/MS-based biological sample analysis.• Validating analytical methods for detecting and quantifying small molecules, biologics, vaccines, and biomarkers.• Defining the SOPs, and their limitations, coupled with a thorough explanation of the actions, including risk assessment and mitigation strategy• Calibrating instruments like Analytical balance, pH meter, Micropipette etc., ensuring the accuracy and determining the traceability of the measurement.• Spearheading the development and implementation within a technical development area (e.g. process and standards, innovation, training, etc.)• Serving as the Clinical Data Management Operations representative in Development Core Team and Clinical Trial Working Groups, as necessary• Contributing towards the development and implementation of methods to oversee CROs and vendors and manage/monitor outsourced data management activities• Incorporating expertise for developing data management and other clinical trial documents, including Clinical Data Management Plans, Protocols, Centralized Monitoring Plans, and Statistical Analysis Plans. • Ascertaining compliance with regulatory requirements and maintaining Data Management components of the Trial Master File (TMF).• Driving the team towards operational excellence by productively collaborating with cross-functional teams in operations, development, biostatistics, statistical programming, medication safety, project management, and regulation. • Facilitated strategic planning to enable the finest use of data management resources within the responsibility area.• Identified appropriate sample preparation and analytical techniques and optimized conditions to ensure reliable and accurate results.• Drafting of activities delivered as per ICH-GLP. Show less • Utilizing study-specific techniques to compile processed study documents in adherence with customer and study requirements.• Collaborating with a team of technicians to prepare samples, perform assays, and analyze data.• Ensured analytical methods were robust and reliable and results were reported accurately and effectively to support decision-making.• Using a project-tracking system, keep track of analytical columns, standards, and other laboratory necessities.• Oversees complete document processing activities like document receiving and review, scanning and indexing, quality assurance, copying, filing, sending or returning to clients or research teams, and archiving, among others. Show less

  • Research Scientist

    Jun 2017 - now

  • Research Assistant

    Jun 2016 - May 2017

  • Trainee

    May 2015 - May 2016