Elaine Siu Email & Phone Number

Vancouver, British Columbia, Canada

Vancouver, British Columbia, Canada

- Develop and validate HPLC assays to quantitate small molecules in various matrices and media used in stem cell research.- Collaborate with various RND teams to determine analytical needs and support new product development by setting up experiments that include determining content, monitoring stability, and assessing impact of exposure to stress conditions. - Assist Process Development in assessing scale-up procedures from RND to Manufacturing.- Support product releases in Quality Control by testing performances of final products.- Introduce and implement systems to track, manage, and store analytical methods and experimental data.- Trained on sterile techniques and on maintaining stem cell lines through media feeds and cell passages.- Assist with maintaining lab functioning.

- Drafted and executed validation protocols to determine analytical parameters of various point-of-care assays. Critically analyzed data using various statistical software including Analysis ToolPak and Analyse-it.- Set-up and carried out real-time stability studies, accelerated stability studies, and transport simulation studies to determine product shelf lives.- Created and updated various technical documents including Standard Operating Procedures, Work Instructions, Investigation Reports, Stability Reports, and Package Inserts.- Updated design control documentations including Product Design Specifications and Design History Files.- Collaborated with external statisticians to design experiments and set up models for method comparison studies and to set target ranges for new calibration and verification controls.- Supported development of new point-of-care assay through feasibility studies.- Supported Manufacturing department though troubleshooting and experimental investigations into non-conforming raw materials, in-process products, and final product.- Restructured Manufacturing Records and Bill of Materials to help increase efficiencies in the planning, production, and manufacturing processes. - Acted as Study Coordinator for in-house, WIRB-approved blood donation program. Tasks included assessing each department’s weekly blood requirements, consenting blood donors, and scheduling times for blood donations.- Served as an internal auditor to assess the effectiveness of established quality system polices and ensure conformance with Health Canada, FDA, European, and Japanese regulations.

- Developed, validated, and wrote up analytical methods for assessing the identity and quality of newly synthesized compounds by HPLC and UPLC-MS/MS.- Identified and troubleshot technical and experimental problems and implements solutions using professional concepts and company procedures.- Successfully trained to carry out GLP and non-GLP compliant bioanalytical assays in plasma, tissue, and fecal samples.- Maintained GLP and non-GLP laboratory equipments and their logs.- Tabulated, summarized, and reviewed research data and relayed results within and across functionalities through reports and presentations.- Monitored laboratory supply needs, placed weekly supply orders, and kept departmentalinvoice database up-to-date.

- Developed, validated, authored, and implemented analytical methods for testing of raw materials, production intermediates, and final drug/medical device products.- Operated a wide range of analytical instruments including HPLC, GC/MS, FT-IR spectrometer, FT-IR microscope, DSC, moisture analyzer, viscometer, osmometer, and particle size analyzer.- Transferred various analytical methods from R&D to Quality Control department.- Supported Engineering and Manufacturing departments during the transition of methods from mock-up equipment in R&D to commercial scale equipment by analyzing samples in a timely manner and providing statistical analyses of data using JMP. - Coordinated and executed numerous in-vitro drug release analyses while simultaneously supporting various stability time points.- Led other members of R&D group to deliver high throughput, high quality, and well-documented analyses to allow projects to progress.

- Prepared standards and operated HPLC to analyze various drug-coated medical devices for total content and impurities analyses.- Characterized and qualified drugs for use as a secondary reference standards.- Drafted technical reports to summarize routine analyses and extensive long-term studies.

- Prepared and carried out routine analyses on water, soil, and tissue samples in a cost-effective and timely manner by hydride generation atomic absorption spectrometry and cold vapour atomic fluorescence spectrometry.- Operated, calibrated, and troubleshot laboratory instruments and equipments. - Carried out quality control procedures and kept detailed logs of reagents, standards, stock solutions, and instrument maintenances.- Assisted in maintaining a safe laboratory environment by carrying out monthly safety inspections of the Trace Metals department.