Program Manager
Resume:
LENIN G. LOPEZ
New City, NY
*****@**.***
PROGRAM MANAGEMENT AND OPERATIONS LEADER
Experienced Program Manager in the MedTech industry managing projects of all sizes with efficiency, productivity, and time management. Planned and completed projects to achieve outcomes in Manufacturing, Supply Chain, QA, R&D, and Marketing. Proven track record of successfully overcoming challenges by driving projects through completion based on milestone tracking, risk mitigation, and relationship building with internal and external stakeholders. EXPERIENCE
T2 Biosystems, Lexington, MA, and Remote Aug 2021-Feb 2025 T2 Biosystems addressed unmet needs in sepsis diagnostics as T2Bacteria and T2Candida were the first and only FDA-approved diagnostic tests to provide species identification of sepsis-causing pathogens. Senior Program Manager/Program Manager, Program Management
● Reporting to the SVP of R&D, my responsibilities included the planning and management of program timelines, milestones, resources, risks and mitigations, and leading cross-functional teams across different strategic and operational initiatives.
● Recovered reagent manufacturing in 2023 and closed the year with zero back-orders. Eventually managed production scheduling to create a surplus of product to achieve $2.4M in Q4 sales for end of year and product for T2Resistance, T2Biothreat, and A. baumanni clinical studies.
● Completed the implementation, verification, and commercial launch of a design change for the negative quality controls for T2Bacteria and T2Resistance, as the control buffer matrix became too contaminated to reproducibly manufacture.
● Completed V&V studies to expand the label of the T2Bacteria panel to include the detection of A. baumannii. This additional label was granted FDA approval in 2024 and was launched commercially in 2024.
● Consolidated the T2Bacteria OUS and US product lines into one global part number; this was a key operational initiative to reduce manufacturing and inventory management activities.
● Launched T2Candida and T2Bacteria (reduced volume) to all installed instruments globally which led to a reduction in product COGS of 56% and 34%, respectively.
● Led the closure of internal audit findings related to complaints by implementing a new culture of accountability by using dashboards and weekly reporting to eliminate internal bottlenecks. Under my leadership, the team implemented SOP changes, training changes, and workflow changes. The team also closed 32% (179/578) of the backlog within 6 weeks of starting the project.
● Reporting to the Sr Manager, Technical Operations, my responsibilities included managing projects and teams directly and indirectly, by planning, assessing, and mitigating against risks to projects.
● Implemented Agile/Scrum project management tools, including Leankit, a Kanban board and burndown chart to manage customer complaints, manufacturing process changes, and CAPAs.
● Initiated, planned, executed, and completed the production readiness and tech transfer of the Atellica Immunoassay Analyzer into the Walpole Manufacturing Consumables facility.
● Among many other product issues, identified a contaminating process step in the production of an HIV product line, ultimately changing the process to single-use consumables in manufacturing. EDUCATION/CERTIFICATIONS
PMP, Project Management Professional
Project Management Institute
MBA, Health Sector Management and Entrepreneurship Boston University, Boston, MA
BS, Molecular Biology, Chemistry (Minor)
Active since 2023
Completed
Completed
Montclair State University, Montclair, NJ
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