Rose Chen

Experience

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  UC San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences

  Sept 2007 - Jul 2011

  Focused on thrombopoietin signaling in disease states. Specifically in Molecular, Hematopoietic Stem Cell, and in vivo studies. Lead research projects and managed mouse colony. Supervised student assistants and engaged in project generation. • Organized and conducted the in vivo studies as managing and monitoring the transgenic mouse colony.• Assisted laboratory manager in research projects and coordinated with visiting scholars.• Performed in vivo studies (animal procedures, subcutaneous/IP injection, tissue harvesting, and primary cell techniques).• Performed cell culture aseptic techniques which include bone marrow isolation and hematopoietic stem cells culture. In addition, performed colony forming assay, viral transfection studies and cell proliferation assays. Show less

  • Staff Research Associate II

    Jul 2010 - Jul 2011

  • Staff Research Associate I, Staff Research Associate II

    Sept 2007 - Jul 2010
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  Sanofi Genzyme

  Jul 2012 - Dec 2015

  Assay development and optimization of Immunoassays. Assist senior project manager.• Developed assays and collaborated with validation group to support clinical trials and post-market programs, specifically in immunogenicity/ PK assays: ELISA, western blotting, and immunoprecipitation. In addition in cell culture aseptic techniques and maintained various cell lines. • Engaged in experimental design, troubleshooting, sample analysis, data interpretation, and report/SOP generation with ICH, FDA, and EMA regulations and guidelines in GLP/GCLP/CLIA lab environment.• Assisted senior project manager and management team to coordinate the efficient distribution of department resource for projects related to clinical biomarker development, validation, and testing internally/contracted to external CROs.• Participated in cross functional projects for scientific strategy, operational efficiencies, and deliverable timelines.• Served as a liaison with various R&D teams to align all operational activities/deliverables of CLS.• Served as a central point of communication in the department on resource distribution and the internal governance of resource strategies for project support. Show less

  • Senior Research Associate - Assay Development. Clinical Laboratory Science

    Feb 2015 - Dec 2015

  • Research Associate - Assay Development. Clinical Laboratory Science

    Jul 2012 - Feb 2015
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  Eden Biologics

  Feb 2016 - May 2022

  Report to Vice President of Operational Manager. Lead and manage project activities.• Define and lead the PMO strategy, implement the project management methodologies, standards and tools to drive the successful projects. • Manage and oversee pipeline and CDMO projects. Successfully push 2 projects into Phase 1 at EU and AUS; 2 projects into Phase 3 global studies. Oversee 20+ CDMO projects and maintained customer satisfactory. • Manage and coordinate across the projects to ensure the information related to project deliverables, risks, and issues are effectively communicated.• Identify the major strategic issues for the projects, execute the projects, understand and mitigate the risks of them. Monitor the associated budget.• Present project plan and progress to senior management and potential business forums. Show less Report to Vice President of Research and Analytical Development.• Facilitate communication across the company and support CMO collaborations with a solution orientated focus. • Interact directly with CDMO clients for the execution of projects and provide experienced advisement on defining objectives, requirements, timelines and assumptions.• Assist Vice President of Analytical Development. Conduct guidance in improving communication and implementing efficiency.• Provide project management strategy for pipeline projects. Work closely and communicate effectively with cross-functional stakeholders to ensure the team can successfully execute planned actions on-time.• Response for sourcing the innovator drugs and serving as a liaison with distributors.• Contribute in bioassays such as SDS-PAGE, IEF, Western Blotting and ELISA to support analytical characterization. Show less

  • Associate Director - PMO

    Nov 2020 - May 2022

  • Senior CMC Project Manager - PMO / Senior Scientist - Analytical Development

    Feb 2016 - Oct 2020
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  Bora Biologics

  Jun 2022 - now

  • Lead the PMO team in defining project strategies, assigning project tasks, ensuring the team meets all goals, and ensuring deliverables are provided on time with high quality.• Partner with internal functions, including Finance and Business Development, to ensure cross-functional value is delivered as the enterprise evolves and improves.• Proactively identify, monitor, and escalate cross-function interdependencies. Anticipate risks and address it with team.• Provide scenario analysis for complex issues with significant business impact.• Oversee project progress and monitor the revenue contribution with Finance. Closely watch resource allocation with S&OP team.• Responsible for the organization-wide integration of consistent project management methodologies and terminology.• Responsible for project scope, risks, schedule, budget, quality, and communication• Effectively interact with senior level clients and serves as an escalation point for issues and communication to Client senior management. Show less

  • Director - PMO

    Apr 2023 - now

  • Associate Director - PMO

    Jun 2022 - Mar 2023