Cross functional new product development team leader
MS Office, MS Project, Milestones Professional
Sr. Global Project ManagerNov 2014 to Current Roche Sequencing Solutions － Santa Clara, CA
Joined Roche's sequencing unit at an early stage to drive project management at Genia, a start-up acquired in June 2014 Focused on bringing disruptive sequencing technology to market using an integrated circuit derived platform with nanopore based biochemistry Supported integration of the company into Roche, including Quality Management System, Product Development Process, Design Controls, and Information Technology tools Regularly communicated project status to senior leadership at Roche Sequencing headquarters Partnered with Bina Technologies, another acquisition, to develop a comprehensive data analysis pipeline for Genia's sequencer Worked with Roche's sample preparation team in Pleasanton to align automation efforts for an end-to-end sequencing solution.
Global Project ManagerFeb 2013 to Dec 2014 Roche Molecular Systems － Pleasanton, CA
Completed transition to the Microbiology Lifecycle Team, and took over all project management and project leadership activities to turn around the delayed and challenging development of the Microbiology portfolio on the cobas® 4800 System Led project teams to simultaneously develop three unique Microbiology products and execute three concurrent clinical trials for US FDA submission Drove clinical trial completion and successful 510(k) submission to FDA to expand testing claims in the US market for Chlamydia and Gonorrhea from two specimen types to six specimen types Led and managed six important product launches in 2013, including the cobas® MRSA/SA Test (CE-IVD), the cobas® HSV 1 and 2 Test (CE-IVD), and cobas® CTNG v2.0 Test (US-IVD) Launched the cobas ® Cdiff Test (CE-IVD) and System Release 2.1 software in the US to support the Microbiology and Genomics and Oncology Lifecycle Teams in 2014 Completed 510(k) submissions for the cobas® MRSA and cobas® Cdiff Tests in Q3 2014 Worked on process and design control improvements Partnered with Master Labeling to bring electronic instructions for use to CE markets.
Global Project ManagerJan 2012 to Feb 2013 Roche Molecular Systems － Pleasanton, CA
Worked with new product development teams for the Genomics and Oncology Lifecycle Team to develop companion diagnostic products for personalized healthcare Facilitated project team and milestone meetings to meet development and launch goals Managed project plans, budgets, timelines, design review meetings, risk assessments, and high-level design history file deliverables Participated in a personalized healthcare cross-functional initiative to improve and simplify processes for companion diagnostic projects On-boarded and trained new senior global project manager and transferred activities on the Genomics & Oncology Lifecycle Team.
Regulatory Submissions - Regulatory Affairs ContractorJun 2010 to Dec 2011 LifeScan Corporation － Milpitas, CA
Fulfilled a core team regulatory lead role for a next generation, high priority glucometer to develop strategy and plans for CE marking, registering in Japan, China, and eleven other markets globally Worked with a project core team to register and launch the company's lead technology in Asia Pacific, especially Japan Led submission efforts and managed timelines to meet deliverable requirements for multiple projects Coordinated registration processes with cross functional stakeholders to prepare efficient stock keeping units for global distribution Supported international re-registration, including a broad initiative to change the legal manufacturer for new and existing products.
Operations Lead R&D ContractorMar 2010 to Dec 2010 LifeScan Corporation － Milpitas, CA
Developed strategy and managed all manufacturing for new and existing software products.
Worked with project core teams, extended teams, contract manufacturers, and supply chain to develop and commercialize product.
Successfully met many aggressive, concurrent launch deadlines for global distribution to public consumers, healthcare professionals, and hospitals.
R&D ContractorMar 2010 to Aug 2010 Animas Corporation － Milpitas, CA
Managed labeling development for new and sustaining products.
Worked with project teams and vendors to develop artwork.
Developed product bill of materials and packaging assemblies.
Conducted labeling and simulated use verifications.
Technical Writer - R&D ContractorMay 2008 to Jul 2008 LifeScan Corporation － Milpitas, CA
Worked with R&D scientists and authored reports to assess and make recommendations regarding the biocompatibility characteristics of photometric and electrochemical test strips.
Project ManagerApr 2008 to Jan 2009 LifeScan Corporation － Milpitas, CA
Provided guidance to project teams throughout the new product development process to meet design control requirements.
Composed work instructions for the company's development roadmap to support the product lifecycle and defined electronic methods for design transfer.
Developed a method using process excellence tools to control 3D product models and worked with system engineers to document end-user requirements, provide training, and design model templates.
Worked with a project team to improve the design change process for development teams and reduce cycle time for new products.
Project Coordinator - R&D ContractorJul 2007 to May 2008 LifeScan Corporation － Milpitas, CA
Assisted a project team to implement design control requirements in the development and launch of a novel glucometer.
Provided system expertise, design requirements tracing, resource tracking, scheduling, document organization, and audit support to enable team to meet an accelerated launch date.
Authored a product biocompatibility report, including inputs for a 510K submission.
Research & Analytical ChemistMay 2006 to Jul 2007 Durect Corporation － Cupertino, CA
Conducted research aimed at developing an injectable, sustained delivery system for Risperidone, a drug that treats Schizophrenia Worked with controlled substances in a GMP and non-GMP environment to develop oral, abuse-resistant gel capsules Carried out feasibility work and formulation screening for the oral delivery of Azithromycin to treat acne Utilized rheometry (Brooksfield & Anton Paar equipment), HPLC (Chem Launch & Chem Store software), UV-Vis, and some FT-IR for analytical analysis Coordinated stability experiments and streamlined efforts between formulation and analytical chemists Managed a variable, multi-faceted work flow process and trained colleagues Organized and analyzed data for weekly meetings.
Bachelor of Science, ChemistrySept 2005Santa Clara University － Santa Clara, CAChemistry