Finny Mathew Email & Phone Number

Greater Memphis Area

My responsibilities include:• Directing projects and programs for product development.• Leading and/or supporting product development projects in all phases of the product development process.• Working with teams to plan and manage new product development projects. Work with senior management to manage projects according to company priorities.• Evaluating new technologies for possible use in product development.• Contributing ideas for new products.• Providing technical input and guidance to project teams and technical staff.• Reviewing and approving Development Reports.

Greater Memphis Area

Lead a variety of projects and teams to apply Quest Management System (QMS) principles and tools to ensure Quest Diagnostics TB, LLC (Memphis, TN) is efficient and effective in the delivery of T-Spot.TB assay results while improving customer and employee satisfaction. I will also be responsible for coaching others to learn and apply QMS principles and tools to their daily work at our site.The QMS is Quest Diagnostics' approach to using a set of proven tools and methodologies to drive successful execution of, and results from, key initiatives and day-to-day work. It is the structured way we manage, lead, and solve problems.• Management approach & governance• Breakthrough management and Hoshin planning• Customer insights and solutions development• Process management• Continuous improvement• Project management• Change management

Greater Memphis Area

• Spearheading root cause investigation into Lab Incidents and Non-Conformances, responding to related customer complaints that require metrics data mining and analysis, and providing timely updates with recommended CAPAs to on-site stakeholders and Quest corporate transition team via Skype presentations and Email communications• Leveraging my prior R&D and current Quality experience to support the T-Spot.TB assay Automation Project• Communicating with Lab Operations management regarding potential action(s) required due to abnormal shift in trends observed while generating weekly and bimonthly metrics reports as well as annual QA monitor reports• Writing and reviewing instrument and process/method validation protocols/plans and reports • Redesigned Metrics Generator (Excel) using Visual Basic programming to cut down metrics generation execution time by at least 25% while enabling it to handle three times the data without crashing the software

Greater Memphis Area

• Supporting IQ, OQ, and PQ of automation equipment to be used for ELISPOT assays, full process validations, new product development, and improvements to existing products and technologies, • Leading design and configuration of EtQ Reliance eQMS modules, and moving the eQMS modules through its development cycle (including validation) for implementation in a CAP/CLIA regulated environment• Training employees at Oxford Immunotec on the use of electronic document management system (eDMS), performing Document Controller function for local site as well as eDMS administrative tasks• Writing and reviewing SOPs, work instructions, validation protocols and reports from scientific and quality/regulatory perspectives• Communicating with the Lab Operations regarding potential action(s) required due to abnormal shift in trends observed while generating Quality metrics reports • Evaluating existing procedures to identify areas of improvement in the overall process workflow, and working with a (cross-functional) team to develop and implement solutions based on LEAN principles that helps achieve better product quality, improve process efficiency, or reduce costs • Helping departments with non-conformance investigations and root cause (RC) analysis, evaluating proposed corrective and preventive actions (CAPA) vis-à-vis the RC determined, and monitoring the implementation of approved CAPA for effectiveness• Performing additional functions on an ad hoc basis – e.g., reviewing QC documentation; responding to customer complaints or technical inquiries that require metrics data mining and analysis; conducting internal audits, spot check audits and risk analysis (FMEA).

Greater Memphis Area

• Responsible for the design and conduct of complex experiments in accordance with the company’s Quality System and to regulatory standards to facilitate new product development• Identify new assay concepts and applications of current technology with an emphasis on their commercial potential • Act as a liaison between R&D and a key vendor through collaborative research projects• Assist in preparation of Quality System documentation for an FDA regulatory approval of a Biologics License Application (BLA) - writing and reviewing: equipment and process validation protocols and reports, Standard Operating Procedures (SOP), Device History Records (DHR), Design Change and Product/Process Change documents and reports, Chemistry Manufacturing and Controls (CMC) document, responses to FDA's Form 483, Risk Assessments • Perform additional functions that facilitate smooth functioning of R&D (procure and validate equipment, maintain inventory, update Safety Data Sheets for hazardous chemicals)

Lansing, Michigan Area

• Responsible for day-to-day operations of the laboratory – establishing standard operating protocols (SOP) for all research activities, ensuring adherence to safety protocols, procuring equipment and supplies, and maintaining inventory• Led development of a blood-based lateral flow assay for diagnosis of tuberculosis infection in humans from proof-of-concept phase to performance verification phase (in an IRB-approved clinical trial using ELISA as the benchmark assay for three biomarkers), readying it to be optimized for commercialization (large scale production) • Directed the work of senior and junior scientists to accomplish SBIR grant research objectives as well as company's commercialization milestones on time and within budget• Worked with the CEO in preparing a business plan (competitive analysis, market need/pain point analysis, determining product pipeline and concomitant regulatory requirements), financials, pitch deck, funding requests and technical progress reports that was sent to funding agencies (government, venture capital, pre-seed and angel funds) • Gave technical presentations as needed to assist the CEO in fundraising efforts• Conducted an intellectual property landscape search/review and prepared a preliminary “Freedom to Operate” analysis for legal opinion• Liaised with key collaborators/potential end users - university faculty and technology transfer office, food industry, medical professionals - as well as regulatory agencies to ensure research projects remained on task and on schedule

Lansing, Michigan Area

As the first scientific hire, I was integrally involved in this MSU spinoff founded by Michigan Accelerator Fund to commercialize biosensor technologies, including building the technical research team• Prepared and submitted SBIR grant applications to NIH, NSF, DoD, and Gates Foundation to help raise $1.05M in non-dilutive research funds for the company, also resulting in a sizeable venture capital match • Applied “out-of-the-box” thinking to biosensor research in developing nanoparticle-based assays for food safety and clinical applications to improve the biosensor performance• Co-invented improvements made to nanoparticle-based biosensors - two provisional patents filed by the company in October 2015• Mentored junior scientists as well as undergraduate and high school interns to accomplish their research goals set by the management

Lansing, Michigan Area

As part owner and first scientific hire, I helped kick start this privately owned MSU spinoff focused on commercializing Michigan State University's biosensor technologies• Helped prepare business plans and pitch deck to win the 2006 Great Lakes Entrepreneurs Quest (GLEQ) Emerging Company of the Year ($25,000 grand prize), the 2005 GLEQ New Business Idea ($5,000 grand prize) and the MichBio Life Sciences Launchpad competition for emerging life sciences companies ($15,000 grand prize)• Prepared and submitted Michigan Universities Commercialization Initiatives (MUCI) Grant fund applications and SBIR grant applications as PI to USDA and NIH to help raise $600K in non-dilutive research funds for development of lateral flow assays for Johne’s disease, bacterial meningitis, and Group B streptococci • Mentored undergraduate interns who helped accomplish the biosensor research and development goals as proposed in the funded grant applications

Lansing, Michigan Area

• Helped prepare business plans and pitch deck for the company• Established a Biosafety Level 2 Laboratory from scratch in the Lansing Bio-Incubator facility• Helped the company in its biosensor market validation study through MUCI funds• Worked with the company management to facilitate the biosensor technology transfer from Michigan State University• Monitored the status of intellectual property (under review) licensed by the company and made recommendations to the company management regarding responses to USPTO reviews/office actions

Gandhinagar, Gujarat India

• Reduced production losses from 10% to 2% using appropriate computer tools and improving manufacturing processes in Asia’s first fully automated dairy plant making market milk, butter oil, milk powder, UHT pasteurized milk and ice cream • Planned manpower requirement of each department based on envisioned expansion• Liaised with an external agency appointed to aid the company in starting up the process of getting ISO and HACCP certification

Doctor Of Philosophy (Phd), Biosystems Engineering, 3.89/4.0

Master'S Degree, Food Science, 3.93/4.0

Bachelor Of Technology (B.Tech.), Dairy Technology, 7.84/10