Anupam Talapatra

* As a Core Team Leader, responsible for driving new assay menu on the BD MAX assay platform (new reagents, cartridge consumable and software), specifically in the area of Blood Viral infections: * Contributed towards developing a bottom-up global business plan/financial model for the Blood Viral product line, addressing various high and mid-volume customer segments * Led a cross-functional on-site and virtual project team to define the viral load product concept and features, in alignment with customer, market and business requirements * Led the formulation of a comprehensive project plan, including budget, capital equipment requirements, schedule (Gantt chart) and resources * Led business reviews, escalating as appropriate, risks or concerns to relevant functional leadership and/or portfolio decision team * Business Cadence: responsible for accurate and timely reporting/updates of assigned projects, e.g. project dashboards and business databases, for functional and executive leadership

* Led a global offshore team comprising of Regulatory and Clinical Technical Leads and Medical Writers (> 20-member virtual team spread across multiple geographical locations) * Conducted product Technical File gap assessment and full remediation, in compliance with EU IVDR 2017/746 - included chapters related to Performance Evaluation, Manufacturing, Labeling, Risk Management and Post-Marker Surveillance * Drafted and pitched responses to RFPs from major diagnostics clients, secured Pilot programs with significant future business potential * Led a Pilot program for a global IVD client that received exceptional rating across all performance metrics, that Pilot was converted into a regular program (revenue estimated to be ~ 2M) * Generated SOWs in collaboration with Client Business Partners or Sales Directors from the commercial organization * Managed IVDR-driven consulting partnerships with client companies * Led internal functional initiatives – creation of an IVD handbook, creation of marketing collaterals for global IVD Conferences and Trade Shows

* Managed cervical and lung cancer related assay products based on a flow cytometry platform that allows for single cell analysis of immune-oncology markers such as PDL-1, quantification of HPV E6/E7 mRNA expression and monitoring of cell cycle/proliferation status: * Responsible for labeling claims, Package Inserts and Advisory Notices for all on-market products under different regulatory categories, such as IVD, ASR, GPR, RUO and IUO * Generated Customer Requirements, Design Input Requirements and Product Risk Management Plan for a HPV cervical cancer detection product, HPV OncoTect 3Dx * Performed competitive research and benchmarking to enable product positioning and value messaging * Reviewed and updated submission documentation to help expedite CE marking of 2 products

* Initiated development of gene expression signature based molecular diagnostics tests using quantitative nuclease protection assay (qNPA) technology, for identifying and subtyping cancer tumors * Sourced FFPE specimens from different tumor subtypes and stages * Conducted feasibility of a gene expression signature based test for non-small cell lung cancer (NSCLC) and a multi-biomarker cancer test on HTG microarray platform * Led cross-functional project meetings involving R&D, Operations/Manufacturing, Marketing, Regulatory, Quality, and Bioinformatics/Biostatistics * Contributed to the generation of Regulatory documents (pre-IDE package), Marketing collaterals for a RUO product

Develop and implement a multiplexed (5-plex) immunoassay, compliant with GLP, using the MSD (Meso Scale Discovery) platform and in collaboration with Meso Scale Discovery, Inc., for measuring an inflammatory panel of cytokine and chemokine protein biomarkers in biological matrices from inflammation/auto-immune disease areas, such as lupus and rheumatoid arthritis - Evaluate the application of state-of-the-arts detection technologies such as R & D Quantikine ELISA (Enzyme Linked Immunosorbent Assay), Meso Scale Discovey (MSD) Electrochemiluminescence assay & Luminex xMAP® mutli-analyte profiling fluorescent-dyed microsphere technology in enabling the simultaneous detection and quantitation of multiple protein targets in plasma or serum - Evaluate dose-response outcome in an internal Phase 0 study (preceding Phase 1 clinical trial) by monitoring the release of IFN-gamma from Interleukin-12/Interleukin-18 co-stimulated whole blood clinical specimens, in presence or absence of an antibody drug

Driven by our ethos, The Science of Sure, we're a diverse, dedicated, creative team that develops, markets and services some of the most innovative and accurate diagnostic imaging systems and surgical products on the planet. While we're focused and passionate about our work, we never forget that what we're really doing is giving people greater confidence and peace of mind in their diagnosis—enabling healthier lives, everywhere, every day.Connect with us at hologic.com, on Facebook at facebook.com/HologicJobs, and on Twitter @Hologic_Jobs.