Amanda Smith Email & Phone Number

Mississauga, Ontario, Canada

Mississauga, Ontario, Canada

Mississauga, Ontario

• Responsible for the development, validation and transfer of analytical procedures used to analyze drug substances and drug products
• Lead Scientist for Amino Acid Analysis for the determination of Ninhydrin-positive substances and Ammonium using post-column Ninhydrin derivatization (Onyx PCX instrument)
• Provide project management support including scheduling, preparation, and execution of work along with communicating with clients
• Write and review validation protocols, methods and reports for the R&D department and clients
• Evaluate, optimize and troubleshoot methods as required by clients
• Coordinate method transfers between clients, R&D group, and Raw Material/Finished Product groups

Oakville, Ontario

• Supported Project Managers by managing analytical science related activities with external contract organizations to support the development of injectable pharmaceutical products
• Ensured all method development, validation and method transfer activities were executed as per regulatory and compliance expectations
• Reviewed and approved method development reports and method validation protocols/reports
• Assisted with troubleshooting of analytical method related problems with external labs
• Provided technical support to the Regulatory team for drug submissions to US-FDA and Health Canada
• Performed technical reviews of Drug Master Files (DMFs) from API manufacturers

Brantford, Ontario

• Performed analytical method development on raw materials and finished products for active pharmaceutical ingredients
• Tested and analyzed results for samples using analytical instrumentation and techniques including HPLC, UPLC, GC, IR, UV, ICP-OES, IC, LC-MS, GC-MS, and ICP-MS
• Executed analytical method validation to ensure compliance with cGMP and regulatory requirements
• Generated cGMP documentation such as Validation reports, SOPs, deviations and CAPA’s
• Reported all testing results, deviations and investigational activities encountered during testing
• Strong analytical, investigative and technical report writing skills

Ancaster, Ontario

• Manufactured and tested immune-depleted plasmas for hemostasis research and diagnostics
• Performed clotting assays on coagulation instruments and ELISA to determine specific analytes
• Prepared antibody and protein purification using Affinity Chromatography techniques
• Manufactured in vitro diagnostic ELISA kit components
• Maintained material resources including laboratory chemicals and in-house reagents

Hamilton, Ontario

• Assisted Medical Laboratory Technologists in the Environmental Bacteriology department by conducting bacteriological testing on drinking water, beach water, swimming pool water, sewage, and spas/hot tubs using membrane.

Waterloo, Ontario

• Provided instruction and demonstrations to undergraduate students and taught basic principles and techniques used in the Microbiology lab.