Michelle Mahon

• Head of Design Transfer and Technical support department. Lead a group of Sr. Leaders responsible for Quality Operations, Operations Investigation Unit, Project Management, Validation Services and support and technical transfer and support activities.
• Member of Global Operations, Branchburg site leadership team since 2012.
• Member of the Branchburg site IMT initiated in Q1 2020 to plan and execute site response to the Covid-19 pandemic.
• Trinity Design Transfer project: Lead cross functional team responsible for creating a single harmonized design transfer process across Molecular solutions business areas.
• Co-Lead Liat stabilization team: Implemented critical product technical improvements of the Liat FRTA assay including formulation, test method and specification changes required to stabilize product performance and improve manufacturability.
• Workstream lead in the creation of the Branchburg five year strategy and implemented strategic initiatives in area of Product Portfolio Management.
• Responsible for design transfer activities at the Branchburg site. Achieving 10 - 15 new product launches per year including several Covid-19 related diagnostic products in 2020/21.
• RMD representative for cultural belief program from 2018 to 2020. Unwavering champion, site lead and mentor to Branchburg site culture team since 2012.
• Participate as a front room lead for critical regulatory inspections.
• Manage technical support activities for new product acquisitions/integrations and technical transfer projects.

Leading a team of Sr. Leaders managing New product transfer and launch activities including validation services and support, technical transfer and project management.

• Established Design Transfer and Technical Support organization in 2014. Developed strategic vision, organizational structure, operating model, procedural cadence and governance for the DTTS team.
• DTTS organization transformed the Roche Molecular Systems design transfer process (2015 - 2019) resulting in a 35%reduction in time to market (T2M) with additional product impacts to transfer costs and compliance.
• Developed and implemented a process characterization program to enhance product quality and manufacturability prior to new product launch.
• Created a strong core of statistical resources and knowledge to strengthen Design for Quality and Manufacturability (DQM), validation and process monitoring activities at the Branchburg site.
• Led technical task force teams aimed at resolving complex technical challenges associated with on-market products.
• Participated in the Global Product Care Initiative as the Branchburg site representative.

Lead a teams responsible for functional, analytical and microbiological testing of all PCR Diagnostic Products.

• Established sampling plan strategies for incoming inspections of critical raw materials and primary packaging materials.
• Coordinated construction and qualification activities required to establish new testing laboratory for c6800/8800 platform. Managed all test method development associated with the launch of this new platform
• Member of the task force that established the Product Care and Quality team structure and cadence for the RMS business area.
• Reduced the environment sampling of the manufacturing areas through a risk based approach to sampling and testing which resulted in over$250k in cost savings.
• Led a team to revise the retention sampling approach with a resulting reduction in sample cost of over $500K.
• Participated as a trainer and culture coach for the Culture of Accountability program.

Managed testing teams within Quality Operations with increasing levels of responsibility from Principal Scientist to Sr. Manager.

• Managed quality control functional testing for PCR Diagnostic products.
• Responsible for laboratory management and compliance of all QC testing laboratories and equipment.
• Led a team responsible for re-designing the RMS Stability Monitoring Program including the automation of stability data in SAP.
• Oversee the Operations Investigation teams with a continual year over year reduction in number of non conformances and turn around time.

• Performed PCR functional testing and data analysis for purposes of product release
• Established the RMS Stability monitoring program. Created stability processes, tools, and scheduling protocols for a small team of stability analysts.
• Executed non conformance investigations.
• Established training and on-boarding program for new employees
• Participated in "Fit for the Future" continuous improvement team and delivered several key projects to reduce testing and/or testing costs.

• Completed student intern program which provided an opportunity to work as a medical laboratory scientist at busy regional hospital.
• Cycle through all disciplines (Clinical chemistry, microbiology, hematology, etc) of hospital laboratory over the course of the year.
• Executed thesis on important and simplification of Lyme disease diagnostic testing.