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• Lead/assist in failure investigations and prepare deviation reports and corrective/preventative actions • Write and review technical data, documents, SOPs and proposals from clients• Communicate with clients to provide technical explanations and suggestions on analytical results• Provide guidance, train and mentor analysts within the Analytical Operations department• Knowledgeable in all regulatory guides - ICH, FDA and pharmacopeias (USP, EP, BP)Additional Responsibilities:Certified Co-chair - Joint Health and Safety Committee (Worker representative)• Work closely with the JHSC to identify, eliminate or mitigate workplace health and safety hazards• Conduct monthly inspections to identify actual and potential hazards in the workplace• Perform risk assessments to identify potential hazards and provide action plans to control the hazards• Organize, prepare and chair monthly meetings• Recommend health and safety improvements in the workplace

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• Provided support in specialized testing for extractables/leachables and in-use compatibility studies• Worked closely with the Quality team to resolve issues relating to OOS, investigations and deviations

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• Provided training to staff members on usage of laboratory equipment and software• Subject Matter Expert for Empower 3 software and ICP-OES• Performed internal audits as a member of the internal audit team• Promotions: 2013 (Associate II), 2015 (Associate III), 2018 (Chemist)

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 filtration, streak plating and spread plating to detect the presence of E. coli and other coliform bacteria.

Waterloo, Ontario

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