Thomas Shipley Email & Phone Number

Drug development, QA, and RA services for the pharmaceutical, NHP and dietary supplement industry operating in North America, EU, UK and Australia.

Ottawa, Canada Area

Smiths Falls

Smiths Falls

- A/RPIC and Quality Assurance Person - Ensure compliance with Division 4, Division 5 and Part 6 of the MMPR. Ensure compliance with the Food and Drug Act - Provide guidance for compliance with other sections of the MMPR. - Ensure compliance with the Fertilizer Act/Regulations, Pest Control Products Act/Regulations, Plant Pathogens Act/Regulations, and the Human Pathogens and Toxins Act and its upcoming regulations. - Integrate Food and Drug Regulations, ICH, ISO, Pharmacopeia,… Show more - A/RPIC and Quality Assurance Person - Ensure compliance with Division 4, Division 5 and Part 6 of the MMPR. Ensure compliance with the Food and Drug Act - Provide guidance for compliance with other sections of the MMPR. - Ensure compliance with the Fertilizer Act/Regulations, Pest Control Products Act/Regulations, Plant Pathogens Act/Regulations, and the Human Pathogens and Toxins Act and its upcoming regulations. - Integrate Food and Drug Regulations, ICH, ISO, Pharmacopeia, and Health Canada guidelines into Tweeds quality management system. - Manage materials, equipment and staff of the quality assurance laboratory. - Lead cleaning validations and method validations. - Perform quality investigations and implement corrective and preventative action. - Perform internal audits.- Contribute to research and development activities. Show less

Ottawa

- Contribute to the planning and development of laboratory vaccine lot release operations and comply with safety regulations and procedures.- Ensure quality control procedures and maintenance of laboratory operations according to approved standard operating procedures and the directorate’s quality management system based on ISO 17025 requirements. - Interpret and provide guidance for development of laboratory vaccine lot release operations.- Prepare analysis, results and… Show more - Contribute to the planning and development of laboratory vaccine lot release operations and comply with safety regulations and procedures.- Ensure quality control procedures and maintenance of laboratory operations according to approved standard operating procedures and the directorate’s quality management system based on ISO 17025 requirements. - Interpret and provide guidance for development of laboratory vaccine lot release operations.- Prepare analysis, results and reports to be submitted to supervisors for approval including product trending reports.- Prepare for and participate in laboratory audits.- Participate as an employee occupational health and safety committee member according to the Canada labour code, part II. - Contribute to the development and maintenance of the directorate’s quality management system.- Perform laboratory operations according to approved standard operating procedures.- Review manufacturer’s product protocols and certificates of analysis for approved biologics to ensure compliance with Food and Drug Act/Regulations.- Perform SRID tests for influenza and rabies vaccines, record equipment use, methods/ procedures and analytical results.- Maintain mammalian cell cultures for use in lot release testing of viral and bacterial vaccines. - Perform plaque assays for yellow fever and rotavirus live attenuated viral vaccines in support of the directorate’s lot release program.- Generate data entry templates for analysis of results within the division.- Maintain a database of all analyses generated in the laboratory including inventory/quality control.- Purchase scientific equipment and other laboratory materials.- Operate, verify/calibrate and maintain scientific equipment and identify/resolve associated problems.- Develop and validate inhibitory hepatitis B ELISA for lot release testing of hepatitis B vaccines.- Develop and validate in vitro monocyte activation test for lot release testing of viral vaccines. Show less

Ottawa

- Extensive experience with SM-PCR. Training of Msc, PhD students and international collaborators in the SM-PCR technique- Produce reports on correlations between mutation rates in somatic and germ tissue of nanoparticle, air and cigarette exposed mice and rats- Give oral presentations at biweekly scientific meetings and defend findings- Give oral presentations on relevant toxicology papers during weekly journal clubs- Evaluate scientific data and provide… Show more - Extensive experience with SM-PCR. Training of Msc, PhD students and international collaborators in the SM-PCR technique- Produce reports on correlations between mutation rates in somatic and germ tissue of nanoparticle, air and cigarette exposed mice and rats- Give oral presentations at biweekly scientific meetings and defend findings- Give oral presentations on relevant toxicology papers during weekly journal clubs- Evaluate scientific data and provide advice/recommendations to supervisors based off experimental findings and scientific publications- Develop and optimize in-house SOP’s- Order and manage reagents and equipment for the lab, organize service contracts for equipment, coordinate graduate students and arrange laboratory meetings- Maintain equipment including electrophoresis units, Geiger counters, thermocyclers, freezers, cooled water pumps, vacuum pumps, pipettes and centrifuges-Radiation safety monitor for the Mechanistic Studies Division. Responsible for weekly contamination monitoring of radiation, radioactive purchases/ordering/disposal and safe-practices training of incoming staff working with radiation Show less

Ottawa

- Development and optimization of protocols used in experimental designs of expanded simple tandem repeat analysis- DNA extraction, restriction- Single molecule PCR, southern blotting- Measure polymorphisms of expanded simple tandem repeats to determine the mutagenicity of zero valent iron nanoparticles on somatic cells - Measure polymorphisms of expanded simple tandem repeats to determine the mutagenicity of sidestream cigarette smoke on germ cells-… Show more - Development and optimization of protocols used in experimental designs of expanded simple tandem repeat analysis- DNA extraction, restriction- Single molecule PCR, southern blotting- Measure polymorphisms of expanded simple tandem repeats to determine the mutagenicity of zero valent iron nanoparticles on somatic cells - Measure polymorphisms of expanded simple tandem repeats to determine the mutagenicity of sidestream cigarette smoke on germ cells- Give oral presentations on relevant toxicity papers during weekly journal clubs Show less