Christopher Samperi Email & Phone Number

Boston, Ma, Us

Merrimack, Nh

Gothenburg, Se

Develop and manage Controlled Environment, Microbiology, and Sterility Assurance programs for terminally sterilized medical devices to ensure compliance with ISO 13485. Design, develop and manage new controlled environment installations and associated validations. Manage compliance assessments for and ensure conformance to relevant microbiology / sterilization standards and guidance documents.

Gothenburg, Se

Burlington, Ma, Us

Work with both Terminally Sterilized and Non-Terminally Sterilized products. Perform Bioburden, LAL and Environmental testing. In charge of the Clean Room Gowning Program and Training. Responsible for leading a group of Quality Control Inspectors working with Bovine Tissue. Continually develop and redesign SOP. Initiate Gap Analysis of Quality documentation.

Paris, France, Fr

Billerica, Ma, Us

Bedford, Ma, Us

Lawrence Township, Nj, Us

-Directly involved with QC Microbiology start up operations at the new Devens site-Collected Water for Injection, High Purity Lab Water, Soft Water and Clean Steam aseptically as a part of a system sampling program in a team based setting-Gowned regularly in ISO 8- ISO 5 classified areas to perform various tasks including monitoring and obtaining samples aseptically-Tested various samples for Coliforms, Bacillus Bacteria, and Endotoxin-Took part in creating a site wide Water for Injection sampling program involved in synthesizing the pharmaceutical Orencia-Designed Environmental Monitoring Placement Diagrams for future Sampling Protocol-Used Kinetic Chromogenic Assay for Endotoxin testing of Water, Clean Steam, and In-Process Samples-Analyzed and tested Biological Indicators for specific Thermophile growth for start up production of Bristol-Myers Squibb site wide campus Vessels-Worked extensively with Biological Safety Cabinets and used routine Environmental Monitoring procedures-Investigated, worked intricately with and continually revised and data and documentation programs such as Smartlab, LIMS, Maximo.

- Work with searchlight imaging and micro-array technology.- Use and create an excess of biomarkers for immunoassays to determine the concentration of specific proteins in supernatant, whole blood, and plasma.- Check for cross reactivity between analytes in order to allow up to a 16-plex per well micro-array test that is fast and accurate.- Use serial dilutions of compiled analytes and standards to use as comparisons to the serial diluted tests.

Abingdon, Oxfordshire, Gb

Perform T cell assay for advance Tuberculosis testing. Using white blood cells and antigen binding to test for Tuberculosis. This method allows for the prevention of false positives due to BCG vaccine or exposure to Mycobacterium.

Alexandria, Virginia, Us

-Worked with companies to assess management and teamwork abilities-Provided validated 360 degree assessments as well as providing Hogan Personality Profiles through our partnership-Customized reports for specific client purposes-These assessments also included our custom individual debriefing

Bachelors Of Science, Biology

Bachelor Of Science (Bs), Psychology