East Bridgewater, Massachusetts, United States
Currently, Part of the Business Innovation & Performance Platform, the mission consists in enabling mRNA CoE delivery through agile connection, integration, and ways of working both internally and with externally to the mRNA ecosystem, fostering continuous performance improvement via optimized assets management, governances, operational excellence and deployment of agile ways of working at scale. Served as the FluNXT Biotech Functional Planner and Resource Manager (FPRM) by managing input from Project/Process team-level planning which provides the basis for the scheduling of functional deliverables. Leverages project management expertise in order to develop and/or ensure their current planning approach is based upon functional deliverables. Responsible for providing an integrated view of project related deliverables and the resources required by the FluNXT Biotech Research team and works to resolve cross-project resources, scheduling issues, and budgets within the functional areas. Supported multiple global project teams as project manager for Pre-Development (Pre Dev) projects for North America. Responsibilities include development of program scope and project plan, creation of program milestones and reporting of project metrics, development of risk management tool and reports, track and report project performance, work with project leads to develop and forecast resource, capital, and external costs, and aggregate programs data to report the portfolio level view of the North America early research (Pre Dev) projects. Served as Cambridge site Project Manager overseeing multiple reorganizations impacting the Cambridge site; 1) Sanofi Pasteur Global R&D Transformation initiative 2) Sanofi R&D AFID/Bionnovation relocation. Duties included leading a regional cross functional team with responsibility for coordinating the relocation of multiple programs and associated personnel, implementation of a new hiring plan, facility renovation and construction, establishing plans to monitor and control project risk, site-specific capital expenditures, and regular communication with all stakeholders and senior management.
Serves as the FluNXT Biotech Functional Planner and Resource Manager (FPRM) by managing input from Project/Process team-level planning which provides the basis for the scheduling of functional deliverables. Leverages project management expertise in order to develop and/or ensure their current planning approach is based upon functional deliverables. Responsible for providing an integrated view of project related deliverables and the resources required by the FluNXT Biotech Research team and works to resolve cross-project resources, scheduling issues, and budgets within the functional areas. Supported multiple global project teams as project manager for Pre-Development (Pre Dev) projects for North America. Responsibilities include development of program scope and project plan, creation of program milestones and reporting of project metrics, development of risk management tool and reports, track and report project performance, work with project leads to develop and forecast resource, capital, and external costs, and aggregate programs data to report the portfolio level view of the North America early research (Pre Dev) projects. Served as Cambridge site Project Manager overseeing multiple reorganizations impacting the Cambridge site; 1) Sanofi Pasteur Global R&D Transformation initiative 2) Sanofi R&D AFID/Bionnovation relocation. Duties included leading a regional cross functional team with responsibility for coordinating the relocation of multiple programs and associated personnel, implementation of a new hiring plan, facility renovation and construction, establishing plans to monitor and control project risk, site-specific capital expenditures, and regular communication with all stakeholders and senior management.
Serology Department, Scientific Manager 2008 – To June 2010 • Prepared and managed laboratory budget • Planned and managed all assay development, qualification, validation and GCLP testing activities for all clinical trials (Phase I through Phase III). o Responsible for BSL3 testing involving wild-type Japanese encephalitis and West Nile viruses. o Lead person for assay transfers to contract laboratories. o Negotiated, obtained and monitored laboratory testing activities with outside vendors o Assisted Discovery, Research, and Development groups in the performance of medium throughput testing in support of discovery and NV pipeline projects • Active project team member for all NV pipeline projects in Cambridge. • Worked closely with Clinical, Statistical and Regulatory groups to assure clinical trial goals were in line with FDA guidelines. • Significant involvement in writing sections for Regulatory submissions, including Common Technical Documents (CTD’s) • Responsible for writing or contribution to sections of clinical trial protocols, statistical plans and clinical study reports and editing of all documents. • Primary author on numerous SOP’s and internal reports. Serology Department, Lab Manager 2003 – To 2007 • Oversee the operations of the Serology laboratory and personnel • Plan logistics for Clinical and pre-clinical Bio-analytical assay testing • Oversees the development, qualification, and validation of novel assay • Work with cross-functional teams to ensure an adequate level of information exchange on projects • Present project plans, ideas and results at Serology group and R&D meetings
Research Associate III 2000 - 2003 • Develop, qualify, validate, and perform Bio-Analytical Assays in support of Research, Development, and Clinical Affairs projects. • Data analysis and provision of technical summaries outlining findings • Oversaw up to two subordinates in daily laboratory tasks Research Associate II 1999 - 2000 • Electronically manage sample receipt, maintain lab equipment, and test and replenish reagents and supplies • Set up and use systems (Microsoft Excel) to track samples, data, data analysis, and data summaries • Responsible for the procurement and shipment of clinical trial materials to trial sites • Responsible for troubleshooting problems and modifying protocols when necessary • Write and comply with SOP’s and write assay qualification or validation reports Research Associate I 1996 - 1998 • Maintenance of notebook, paperwork, and department equipment • Reviewing of Standard Operating Procedures (SOP) • Responsible for the receipt, audit, documentation, and query of clinical and research specimens • Perform various small animal (mouse) studies