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Work Background
RocheGlobal Project Manager
Mar. 2024
AbbottProject Manager
May. 2023 - Mar. 2024• Ensured compliance with regulatory standards such as FDA requirements by tracking and analyzing data related to product specifications and manufacturing processes
• Prepared reports and documentation for regulatory submissions, including data validation and verification.
• Led and executed the Corrective and Preventive Action (CAPA) program, resulting in a 30% reduction in product defects and a 15% improvement in regulatory compliance
• Implemented robust CAPA procedures in alignment with FDA regulations and ISO 13485 standards
• Mentored junior team members in CAPA methodologies and best practices.
SartoriusProject Manager
Oct. 2022 - Apr. 2023United States• Spearheaded 3 internal biopharmaceutical projects from initiation to close while monitoring and adhering to stage-gate processes leading to a 100% success rate • Champion all project management functions including definition of project scope and objectives, assignment of resources to work items, follow up on tasks and progress, management complex global schedules, timelines and stakeholders
• Leverage foresight on project progression, project team, and other factors to identify, track, and mitigate risks via the project Risk Register.
• Implement project management tools, templates, and best practices to ensure project teams are organized, effective and accountable • Lead resource management by creation and maintenance of resource planning lists, tracking how are resources are used throughout the project and reviewing constraints and availabilities
• Manage all cross-functional communications with stakeholders and sponsors, as well as lead project team meeting and governance meetings, creating agendas, presentations, and managing minutes and action-items
• Facilitate successful project close out including archive of all project documents
Thermo Fisher ScientificJunior Project Manager
Mar. 2020 - Aug. 2021• Successfully led 72 manufacturing projects at a world-leading Fortune 500 (90% project success rate manufacturing high quality custom oligonucleotides)
• Managed project resources and a project team of 3 in a high throughput, fast-paced environment, manufacturing oligonucleotides for use in the biotech industry • Lead all project management efforts including identification, tracking, and mitigation of risks, creation of project plans for each order, creation and tracking of timelines/ scheduling for project teams, and communication to sr. managers (sponsors) in an Agile project environment • Troubleshoot/ maintain instrumentation and evaluate data analyzed on two MS instruments per day including two sets of QC samples and 40 samples with over 100 compounds per sample
• Facilitated quality control, SOPs, and protocols, reviewing all laboratory batch records and test results at 100% for completeness and accuracy as well as ensuring good manufacturing process is followed throughout the project • Analyzed data from the quality control process and created reports outlining outcomes and number of processed plans for project leadership/sponsors, and following shifts • Perform data quality control and validation, creating new algorithms for Next Generation Sequencing (NGS), genotyping and validating genomic data sets
• Ensured data quality by verifying data for completeness, accuracy, and consistency
• Strengthened training and SOPs across the organization by developing and conducting training programs for new project team members (operators, technicians) and creating SOPs through Agile eDMS system
Solano PharmacyPharmacy Coordinator
Dec. 2017 - Feb. 2019• Strengthened the capabilities of sales representative team over the course of 2 years through training, mentoring and development
• Led 2 projects including training revamp project, EMR training project
• Worked closely with leadership to ensure training, claims, front desk, and special projects were delivered accurately, on-time, and risks/ issues were addressed
• Expert in Epic and RX30 EMRs, entering and organizing patient data for administrative and clinical teams while maintaining strict confidentiality to remain compliant with HIPPA regulations
• Analyzed claims for errors, rectified issues and mailed out updated documents.
University of California, MercedResearch Assistant Undergraduate Microbiology
Oct. 2016 - May. 2017• Managed 3 research projects including the quantification of candida albicans and identify growth mechanisms
• Conducted culturing, incubation, and quantifications of candida albicans • Maintained lab cleanliness and ensured proper sanitization • Performed microbial drug assays • Assisted in preparing fungal cell culture and materials needed for laboratory experiments • Knowledge of good laboratory practices (GLP) applicable to specific lab setting
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