Senior Director, Head of MDx Dev NA Assay Technologies, MDx Dev NA Assay Technologies @ QIAGEN
post-doctoral fellow, molecular biology @
The Johns Hopkins University
Demonstrated team leadership in product development for over fifteen years in molecular diagnostics, and assay development with a focus of real-time PCR, multiplex PCR, infectious diseases' diagnostics, Women's Health and Sexually Transmitted Diseases diagnostics, Hospital-Acquired Infections, 510(k) submissions, CE-mark, pre-IDE FDA submissions and presentations, working closely with Operations, Quality & Regulatory as well as Instrumentation teams in
Demonstrated team leadership in product development for over fifteen years in molecular diagnostics, and assay development with a focus of real-time PCR, multiplex PCR, infectious diseases' diagnostics, Women's Health and Sexually Transmitted Diseases diagnostics, Hospital-Acquired Infections, 510(k) submissions, CE-mark, pre-IDE FDA submissions and presentations, working closely with Operations, Quality & Regulatory as well as Instrumentation teams in a multi-national team effort. Successfully led PhD level scientist-teams to release real-time PCR products, assays and PCR enzymes working collaboratively within product development with teams focused on microfluidics, engineering, molecular (and immunoassays).
Authored multiple papers and patents in PCR polymerase-development technologies, infectious diseases' diagnostics, micro-fluidics and PCR enzymes.
Extensive experience working in global large, mid-size and start up companies and excel in building multidisciplinary teams and projects under aggressive timelines. Headed alliance management programs, budgets and deliverables for multiple FDA-submissions, outsourcing MDx groups and portfolios, integral part of due diligence teams for M&A.
Specialties: molecular diagnostics, infectious diseases' diagnostics, regulatory and FDA submissions for 510k, CLIA waiver and CE-mark, assay development, cross-functional team lead, multiplex end-point and QPCR in real-time technology, NGS, outsourcing and alliance management, immunoassay development
Vice President, Alliance Management @ Strategic management of top 20% of pharmaceutical and MDx accounts, alliance management of product services in pharma biomarker discovery & development, IVD diagnostics, personalized medicine and R&D services.
Heading strategic alliance programs for drug trial/research services, MDx assay development via QPCR and NGS (Illumina MiSeq/HiSeq and Life/Thermo NGS) technologies for IVD and FDA submissions, client and product expectation management,
Strategic leadership in marketing and sales trends, revenue generation and spearheading strategic product development plan in line with company goals and revenue stream management From January 2015 to Present (10 months) Greater San Diego AreaHead, Alliance Management @ Strategic lead in management of pharmaceutical and MDx accounts, alliance management of product services in companion diagnostics (CDx), personalized medicine and R&D services.
Develop business strategies and partnerships with pharma and molecular diagnostics global companies
Manage, and maintain key alliances for drug trial/research services, MDx assay development via NGS, QPCR and microarrays for IVD and FDA submissions
Lead strategic and focused management of client & account alliances
Lead, and manage internal resources, matching with client expectations in achievement and execution of study trials and programs CDx, and MDx-related submissions From February 2014 to Present (1 year 9 months) Greater San Diego AreaSenior Director, Head of MDx Dev NA Assay Technologies, MDx Dev NA Assay Technologies @ Strategic leadership of Women’s Health and Sexually Transmitted Disease Area Platform and Assay Design, PMA, 510k and CE-IVD regulated assay and platform submission in Hospital Acquired Infections and Women’s Health panels
Strategic product planning, budget, resource and cost center monitoring of all North American sites for Assay Development,
Managing and mentoring 45-member team of Project Managers, Senior Team Leaders, Ph.D-level scientists and Product Transfer/Operations specialists,
Strategic input into North America Marketing, Sales and Business Development activities, QIAGEN, Inc. From November 2012 to January 2014 (1 year 3 months) Gaithersburg, MarylandSenior Director, Assay Development and R&D Services, R&D Americas @ Tactical and strategic leadership role as R&D and MDx Assay Development leader, Qiagen Inc. North America—leading R&D efforts in successful FDA and CE-IVD submissions for Women’s’ Health related real-time PCR assays including HPV, HSV and GBS, hc2-based HPV Genotyping assay (CE-IVD), developing strategic landscape for QIAGEN in high-throughput instrument and infectious diseases’ diagnostics assay development from sample to answer with tactical road mapping of global products From March 2012 to October 2012 (8 months) Gaithersburg, MarylandTeam Leader, Product Development @ Spearheaded the product and assay development of Enigma® ML instrument’s multiplex respiratory viral real-time sample-to-answer test by leading cross functional Ph.D.-level international teams (UK and US-based) through product development for FDA submission and approval, provided tactical and strategic insight to project planning and deadlines, worked closely with CEO, CFO and VP, Regulatory, Operations, Quality Control under aggressive deadlines to develop multiplex assays focused on infectious diseases' diagnostics, audited research, clinical and manufacturing sites, authored and managed documentation involving FDA 510(k) and CLIA-waived submissions, pre-IDE FDA submission, Project Management and test method validation.
Actively collaborated with UK-based research and engineering teams, established contracts with outside vendors, clinical labs and groups for sample acquisition, as well as prospective investors. Guided, mentored and supervised direct reports (PhD and MS level scientists). Executive Certificate in Global Conflict and Negotiations (Thunderbird University, 2011). From March 2010 to March 2012 (2 years 1 month) Director of Science Communication @ Bio4Front, Inc. delivers customized education and informational programs to corporate, governmental, institutional and academic clients. With a special focus on biotechnology, Bio4Front offers sessions in various aspects of the science, business and processes of the biotechnology industry. Bio4Front's faculty combine extensive industry experience with a zeal for teaching. From May 2009 to July 2010 (1 year 3 months) Consultant, Assay Development @ From January 2009 to May 2009 (5 months) Director, Molecular Assay Development @ From October 2007 to January 2009 (1 year 4 months) Staff Scientist @ From April 2005 to October 2007 (2 years 7 months) Staff Scientist @ From March 2002 to February 2005 (3 years)
Executive Certificate, Global Negotiations @ Thunderbird School of Global Management From 2011 to 2011 post-doctoral fellow, molecular biology @ The Johns Hopkins University From 1998 to 2000 Ph.D., Biochemistry @ University of Maryland College Park From 1995 to 1998 M.S., Biochemistry @ Stony Brook University From 1993 to 1995 MS, Chemistry @ Indian Institute of Technology, Delhi From 1991 to 1993 Madhushree Ghosh is skilled in: Infectious Diseases, Biotechnology, Molecular Biology, Diagnostics, qPCR, PCR, Microfluidics, Medical Devices, Life Sciences, R&D, FDA, ISO 13485, Product Development, GMP, Cancer, Strategic Planning, Healthcare, Product Management, Start-ups, Personalized Medicine, Design Control, Management, Hardware Diagnostics, Scientists, Assay Development, Genomics, Lifesciences, Molecular Diagnostics, Strategic Leadership, Biopharmaceuticals, Commercialization, Creative Writing, Dramatic Literature, DNA, Technology Transfer, Immunology, Validation, Drug Discovery, GLP, Biochemistry, Medical Diagnostics
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