Jamie Flanagan Email and Phone Number

Immunoassay PortfolioInfectious Disease & Immunosuppressant DrugsAccountable for developing marketing commercializations strategies, programs, and messaging to drive growth, profitability, and predictability. Provided leadership to develop and deliver strategic and tactical business objectives utilizing my expertise of the US IVD market, competitive landscape, and the benefits of the Roche solution.Leverage relationships with disease state and industry Key Opinion Leaders to support commercializations initiatives to ensure success of the ID and ISD portfolios in the market.Lead the strategic development of segment marketing initiatives to create value and growth within the Centralized Diagnostics business.

Immunoassay PortfolioInfectious Disease/Oncology/Women's HealthAccountable for developing marketing strategies, programs, and messaging strategies to drive growth, profitability, and predictability. Provided leadership to develop and deliver strategic and tactical business objectives utilizing my expertise of the US IVD market, competitive landscape, and the benefits of the Roche solution.Work with local departments to manage and support product initiatives and projects along with sales and customer education to ensure success of these portfolios in the market.Lead the strategic development of segment marketing initiatives to create value and growth within the Centralized Diagnostics business unit.

Clinical Chemistry Specialty AssaysDiabetes / DAT / TDM / ISD / Specific Proteins / CDxAccountable for developing marketing strategies, programs, and messaging strategies to drive growth, profitability, and predictability. Provided leadership to develop and deliver strategic and tactical business objectives utilizing my expertise of the US IVD market, competitive landscape, and the benefits of the Roche solution.Worked with local departments to manage and support product initiatives and projects along with sales and customer education to ensure success of these portfolios in the market.Lead the strategic development of segment marketing initiatives to create value and growth within the Centralized Diagnostics business unit.

*Successfully achieve annual Reagent Retention and Growth across the Pittsburgh/Upstate New York Territory. Retained, extended, and acquired Centralized Diagnostics business for specified product lines through effective identification of opportunities, providing solutions, gaining agreement, implementing solutions, and managing accounts as defined by the CD Sales Process. 2012 CC/IA Performance 92% to plan, UA Performance 106% to plan. *Effectively manage current customer by continuing to build trust with putting my customers first. Quickly and effectively solving their issues at hand by reaching out to pricing, contracts, marketing, customer service, as well as technical support to ensure I have an accurate response / resolution for the customer with any issue they bring to my attention (standing orders, scheduled deliveries, and/or pricing issues). *Continuously identify opportunities within territory utilizing Miller Heiman tools to ensure a consistent and complete strategic approach. Utilize the breadth of product portfolio to maximize Roche utilization in accounts. *Prepare accurate territory business plans, forecasts, and sales reports to achieve assigned sales quota. As well as, timely and effective utilization of sales support and territory planning/management tools (i.e. CMA, LMT, Clarify) to identify, manage and communicate sales opportunities.*Strong knowledge of Roche product features, benefits, and understands how to position our solution versus the competition.*Support the Great Lakes and Philadelphia regions during vacancy on the team by continuing to grow the business with focused channel filling activities and UA ownership.

*Perform in-process titering activities including antibody preparation, formulation of antibody-microparticle reagents, bihapten-conjugate reagents, as well as antibody and microparticle reagents.*Perform in-process titering testing utilizing numerous Roche analyzers: Hitachi 917, Cobas c501, Modular P, Integra 800, and Integra 700 all while providing complete thorough documentation of product testing, result analysis, and equipment maintenance, troubleshooting, and repair.*Review of detailed manufacturing instructions for Clinical Chemistries, Drugs of Abuse (DAT) assays, and Therapeutic Drug Monitoring (TDM) assays sub-bulk as well as bulked reagents.*Prioritize tasks in a highly stressful environment signifying the use of multitasking skills and a sense of urgency. Carry out procedures, tasks, and instructions effectively and efficiently with minimal supervision.*Execute initial investigations related to aberrant test results as well as author justifications for Failure Evaluation Investigations (FEI).*Certified Trainer for the Hitachi 917, Modular P, and Cobas c501, as well as the reagent titering process for RDO and RDG colleagues.*Provided cross-functional support to the Production Release Office (PRO) by reviewing and releasing approximately 600 backlogged Weighmaster Edit Forms. In addition, completed the PRO certification to provide additional assistance with reviewing and releasing sub-bulk, bulk, and raw material documents.*Provided cross-functional support to Roche Tech Affairs with the screening of farm bleeds for purified benzodiazepine antibody determination.

Quality Control Laboratory*Earned numerous analyzer certifications: Cobas c501, Hitachi 917, Hitachi 717, Integra 700, as well as Integra 800.*Performed final release testing utilizing all of the above mentioned analyzers all while ensuring thoroughness and attention to detail including documentation of product testing, result analysis, and laboratory and equipment maintenance, troubleshooting, and repair.*Audited Quality Control product testing documentation for DAT/TDM assays.*Prioritized tasks effectively with minimal supervision displaying sense of urgency and ability to multitask.*Executed initial investigations related to aberrant test results.*Modified quality procedures within a document control process that is compliant with Quality Systems Regulations.

*Performed in-process and final release testing utilizing numerous diagnostic testing platforms and technologies: Roche Hitachi 717 (QMS technology), Abbott ARCHITECT (CMIA technology), TDx (FPIA technology), and Aeroset (Immunochemistry technology).*Performed test scheduling, as well as quality control document review, approval, and release of OEM and Innofluor products. *Completed all incoming diagnostic material inspections, testing, and documentation.*Successfully implemented participation with numerous proficiency surveys, US and Worldwide for numerous Innofluor assays including Certican, Vancomycin, and Topiramate. *Created as well as modified quality documents and procedures within a document control process while maintaining compliance with the Quality Systems Regulations. *Responsible for the training of Quality Control Scientists in GMP environment; which included instrument maintenance, mechanics, operation, and troubleshooting, as well as training of quality documentation.

*Supported numerous projects with in-depth understanding of diagnostic products and processes while maintaining compliance.*Successfully lead several projects and cross-functional teams associated with the implementation of diagnostic product stability trending, forecasting, and product dating through Laboratory Information Management System (LIMS).*Responsible for stability failure investigations, identifying and communicating issues, including assessment of risk, and recommendation for the course of action.*Performed gap analyses among numerous quality documents and procedures by identifying the changes necessary and providing change, reason, and justification for each change identified in compliance with Quality Systems Regulations.*Provided supervisory direction to indirect reports.

*Product Leader; responsibilities included planning, scheduling, executing, investigation of failed stability tests, and documentation of on-market stability studies while ensuring good manufacturing practices and ownership of approximately 55 products.*Monitored product stability in the field through performance testing utilizing numerous diagnostic testing platforms, including Certifications on the Abbott ARCHITECT and IMx platforms, and general knowledge of the additional X-Systems, Testpack (Rapid), and PRISM platforms. *GMP Co-coordinator, Material Review Team member, and On the Job Trainer qualification.*Experience with writing, investigating and documenting elevated customer complaints.