Biotechnology Innovation Services
Call Us At 508-404-1120
Christine Burns has served the biotech tools and diagnostics industry for many years, directing R&D in product development and technical support, as well as leading Operations in manufacturing and quality. Chris has experience in General Management, project management, and business development and has successfully initiated new businesses within organizational frameworks. She has managed a number of laboratory operations including CLIA regulated labs. She is an expert in the design and development of immunoassays and has extensive experience developing biomarker assays for clinical trials and companion diagnostics.
Dr. Burns started her career in diagnostics at Baxter Healthcare, the Clinical Assays division, where she was responsible for the development of small molecule and protein assays. There she designed, synthesized and patented proprietary hapten antigen conjugates and led the monoclonal and polyclonal antisera program.
At Advanced Magnetics, Chris directed all aspects of R&D and Operations for two RUO product lines and one diagnostic product line, and further commercialized the launch of multiple research immunoassays and the first magnetic particle products for molecular biology and cell sorting applications.
Chris spent several years at PerSeptive Biosystems in various senior management roles. As VP of R&D, Clinical Chemistry, she managed a drug discovery group exploring peptide and small molecule screening, an immunology group developing immobilized enzymes for peptide mapping and antibody digestion, an immunoassay group developing cyclic nucleotide and eicosanoids assays and a molecular biology group exploring sequencing by mass spectrometry. As VP of WW Tech Support, she established a premier application, training, and call center and managed support of several instrument and consumable lines. As VP of Contract R&D Services, she developed an analytical and purification business focused on services for mass spectrometry.
Chris joined Endogen/Pierce Biotechnology as VP of R&D and managed immunoassay development as well as the cloning expression group for novel cytokines and proteins. As the General Manager of the Pierce Boston Technology Center, she developed and launched the first planar-based multiplexed immunoassay platform. Under Thermo, Chris managed the SearchLight multiplexing immunoassay sample testing lab and product business including imager, software, and consumables. The CLIA lab measured protein biomarkers for thousands of clinical samples in various trial stages. At Aushon, Chris led R&D and continued the expansion of the product line into toxicology, oncology, and angiogenesis and provided technical and sales support.
As SVP at BG Medicine, Chris was responsible for Program Management, Quality Assurance, Customer and Technical Support. She directed outsourced manufacturing and QC for their FDA cleared product and led the submission of their first IVDMIA 510k.
Chris Burns has extensive experience in the development of immunoassays for clinical and research use only, focusing on accurate measurements of biomarkers for elucidating disease and stratifying patients. She has experience in developing hundreds of LDTs and in the regulatory aspects of using biomarkers in IVDMIAs. With her operational background, she has experience in creating documentation systems that support CLIA, GLP, GMP and ISO standards. With her General Management experience, she understands the integration of these entities. With her technical, strategic, and business development expertise she can evaluate marketable and potentially commercial opportunities at a very early stage.
Chris currently works as a consultant in research and development, manufacturing and business development where she has created business plans, competitive analyses, go-to-market strategy, and alliance and customer development. She has worked on helping clients build a biomarker pipeline and finding groups of proteins that may define a disease signature. She has worked on projects to optimize assays for greater sensitivity and reproducibility that incorporate the evolution of software and hardware. She has worked with novel assays and technologies and created validation strategies and protocols.