Proven Assay Development Associate Scientist with a robust background, excelling in assay development and scientific writing. Demonstrated expertise in enhancing data accuracy and project monitoring, coupled with exceptional attention to detail and time management skills. Achieved significant advancements in research methodologies, contributing to groundbreaking scientific discoveries. Talented individual educated in safety procedures, processes and regulations. Leverages exceptional knowledge to perform complex assays and testing. Accomplished with 3 years of experience performing and documenting regulatory document collection, Diligent in performing studies aligned with good clinical practices, study-specific requirements. In-depth knowledge of company procedures, regulatory requirements and quality standards.
• Maintaining different cell lines in our cell culture department including cell passage, counting and viability assessment.
• Contributing to protein expression using transient transfection technology.
• Using Baculovirus expression to express proteins in in insect susceptible cells.
• Participating in the production of PseudoParticles (PPs) as potent viral surrogates used in vaccine clinical testing.
• Expanding plasmidic DNA in E.coli strains to obtain high quality low endotoxin products.
• Evaluates validity of analytical results against the algorithms displayed by the lab computer system.
• Identifies and documents potential performance errors or otherwise unusual results and escalate to senior lab personnel.
• Responsible for preparation of buffers and solutions for analysis, as required.
• May perform secondary review of analytical results when signed-off as competent to do so for applicable instrument(s) and/or data type(s).
• Responsible for post analysis sample and reagent storage.
• Assists in the development and writing of new laboratory procedures and techniques.
• Assists in good housekeeping of the lab environment, consistent with 5S standards.
• Notifies appropriate staff of supply shortages.
• Responsible for clear, accurate, and timely communications with cross functional stakeholders.
• Participates in continuing education through self-study, attending in-services and lectures and meetings.
• Supports safety, quality, and 5S requirements and initiatives.
• Complies with company's procedures and applicable regulatory requirements
· Conducting pharmaceutical preclinical drug development research as per ICH E-6 guidelines and as per Health Canada Food and Drug regulations;
· Work in line with Good Laboratory Practices (GLP); Good clinical practices (GCP); and Good Documentation practices (GDP)
· Responsible for data entry and operating a computer terminal. Keep accurate study records that are legible and organized.
· Review study protocols and perform experiments for clients belonging to large- and small-scale pharmaceutical companies.
· Analyzed data, identified trends, reviewed and prepared data tables for study reports.
· Maintaining the studies from start up to close out phase including presenting the statistical data of the studies using Provantis software
· Monitor ongoing clinical studies to verify compliance with protocol, regulatory requirements, and GCP guidelines
· Collect and evaluate research data for correctness and completeness. Assist with preparing research materials and coordinating with sponsors and investigators to address any difficulties or concerns during the trial.
· In compliance with acceptable animal care principles, performs technical responsibilities in the performance of in vivo research studies or support services. In accordance with relevant regulations and SOPs, prepares, gathers, and records research data and specimens.
· Handle disease induced and transgenic laboratory animals while adhering to the Institutional Animal Care and Use Committee (IACUC) regulations on animal welfare
· Animal health monitoring and data recording with Provantis 10, as well as managing general vivarium maintenance in numerous studies
· Communicate with the team leader and colleagues on a daily basis to guarantee efficiency and correctness.