Bachelor of Science (BS) @
University of Rochester
Director of Quality Assurance @ From April 2014 to Present (1 year 7 months) Cambridge, MAAssociate Director, QA @ From June 2012 to April 2014 (1 year 11 months) Cambridge, MADirector of Technical Operations @ Since joining Progenika, I have enabled the laboratory to successfully deliver high quality results with high customer satisfaction, improved the validation and
Director of Quality Assurance @ From April 2014 to Present (1 year 7 months) Cambridge, MAAssociate Director, QA @ From June 2012 to April 2014 (1 year 11 months) Cambridge, MADirector of Technical Operations @ Since joining Progenika, I have enabled the laboratory to successfully deliver high quality results with high customer satisfaction, improved the validation and implementation process for new assays and have implemented policies and procedures to meet College of American Pathologists (CAP) accreditation requirements.
1. Directed clinical testing laboratory (sequencing, MLPA, genotype arrays, ELISA)
• Ensure all testing completed meets CLIA and CAP regulations as well as those specifically applicable to individual state licenses held by Progenika (MA, CA, FL, MD, RI, PA). Successfully guided lab through MA State/CLIA and CAP inspections.
• Supervised all lab operations including hiring, training and scheduling of staff.
• Validate and document transition of new tests and technology into clinical laboratory.
• Responsible for establishing and implementing QA/QC policies.
• Established billing relationships with patient health insurance companies
• Provided detailed cost analysis for tests performed to COO to enable informed pricing strategy
• HIPPA and Laboratory Safety Officer.
2. Directed US efforts to market and install Progenika Biopharma developed assays at client sites.
• Managed Application Scientist responsible for platform installation and client training
• Wrote and reviewed package inserts, user guides, IQOQPQ document and other commercial documents
• Directed troubleshooting activities From November 2009 to June 2012 (2 years 8 months) Greater Boston AreaDirector of Laboratory Operations @ I improved laboratory structure, adherence to SOPs and proper documentation and implemented QC practices which
1. Ensure that all testing completed meets CLIA regulations as well as regulations specifically applicable to individual states
• Successfully prepared and guided laboratory through MA State/CLIA, NY State and CAP regulatory inspections
• Wrote, reviewed and revised SOPs and monitored technician compliance
• National Credentialing Agency for Laboratory Personnel (NCA) Certified Laboratory Specialist in Molecular Biology (CLSp(MB))
2. Managed all staff involved with sample testing including laboratory testing technicians, data analysts, and administrative personnel
• Scheduled daily work for laboratory technicians and prioritized patient tests
• Hired and trained personnel, maintained detailed training records and completed competency reviews
• Responsible for laboratory safety policies and technician adherence
• Reviewed data and test results before submission to laboratory medical directors for release to patients From April 2008 to October 2009 (1 year 7 months) Associate Director, SearchLight Technical Support @ During my six year tenure at Pierce, I was a key contributor to the success of the SearchLight® Multiplex Array business from initiation of the first product to a business with $6 million in yearly revenue.
Associate Director of Technical Support 9/2005-3/2008
1. Technical support for internal operations
• Provided support for CLIA Service lab personnel as technical supervisor by: 1.setting appropriate assay conditions for testing and in analyzing and reporting data for best results, 2. designing array panel configurations to maximize performance of all assays, 3. training of service technicians on correct data handling and interpretation, and 4. designing trouble-shooting experiments to address problems
• Consulted with R&D group in determining acceptable validation criteria for assays, news assays in development and interpretation of experimental results
• Designed experiments for trouble-shooting any product failures in manufacturing and QC
2. Primary contact for clients with technical issues or questions related to SearchLight platform.
• Discussed and designed experiments for clients with technical issues, instructed lab personnel on how to conduct follow-up work, prepared and reported results to clients including QC results related to testing
• Provided technical support and documentation for questions related to sample handling and preparation for various matrices including serum, plasma, tissue homogenate, tissue section lysates, amniotic fluid, lavage
• Prepared GLP-style reports for clients when requested and formatted data to specification required by clents
• Reviewed data before reporting results to client to insure accuracy of data summary From September 2005 to March 2008 (2 years 7 months) Technical Operations Manager @ 1. Directed manufacturing and QC of SearchLight custom kits, catalog kits and reagents for SearchLight service-based business
• Made all final decisions related to manufacturing procedures, QC, trouble-shooting and any changes to assay (new reagent or calibration)
• Scheduled and prioritized manufacturing of all SearchLight products, and raw materials, many with a turn-around-time of less than two weeks from start of project to final product QC and shipment
• Established practices and wrote SOPs for manufacturing and QC to enable those groups to meet their deadlines, to reduce errors, and to improve over-all product quality and consistency
• Created and updated manufacturing documents including product masters, bill of materials, SOPS, and working documents
• Created system to easily track all reagents used including vendor lots, titers, and costing information
• Insured that documentation was properly completed and maintained for manufacturing and QC
• Developed SOP for transferring new products into manufacturing/service to insure that all necessary documentation was complete, assay validation complete, and relevant information filed for reference by all groups
• Wrote instruction booklets for custom products
Senior Research Scientist 8/2002—5/2004 From June 2004 to May 2005 (1 year) Woburn, MASenior Research Scientist @ 1. Developed SearchLight proteome array kits sold in Pierce catalog including all human chemokine arrays, neurothrophic factors and rat arrays for the quantification of multiple proteins in cell culture supernatants, serum/plasma, bronchoalviolar lavage fluid, and other biological samples. Also custom developed protein arrays for clients.
2. Developed and wrote S.O.P. for validating SearchLight proteome arrays
3. Developed method for high-throughput screening of antibodies from animal test bleeds in antibody development program From August 2001 to June 2004 (2 years 11 months) Woburn, MA
Doctor of Philosophy (PhD), Biomedical/Medical Engineering @ University of Rochester From 1996 to 2001 Bachelor of Science (BS), Chemical Engineering @ University of Rochester From 1992 to 1996 Christine Vietz is skilled in: Molecular Biology, Laboratory, Validation, Cell Culture, ELISA, Assay Development, Immunoassays, Sop, Quality Assurance, Protein Chemistry
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