Monica Le

Monica Le Email and Phone Number

Senior IT Business Systems Analyst, Research - IT @ Apellis Pharmaceuticals
Waltham, MA, US
Monica Le's Location
Waltham, Massachusetts, United States, United States
Monica Le's Contact Details
About Monica Le

Results-driven Senior IT Business Systems Analyst with over a decade of proven excellence in driving business process optimization and technical solutions within the pharmaceutical and research industries. Boasting a track record of thriving within GxP Regulated settings (adhering to FDA: 21 CFR part 11, EU: Annex 11 standards). Adept at collaborating with cross-functional teams to consistently provide valuable insights and strategic leadership to enhance research workflows, data management, and laboratory operations. Skilled in project management, technical consultation, and system implementation. Possess unwavering confidence, persistence, and a forward-looking perspective that are pivotal in driving accomplishments. Excel in aligning IT strategies with business objectives to achieve operational excellence.CORE COMPETENCIESSkills/Proficiencies: Pharmaceutical and Research Industry Expertise | GxP Regulation Adherence | Business Process Development/Optimization | Gap Analysis | Business Process Mapping | Computer Software Validation (CSV) | IT SDLC Methodology | Project Management | Confident and Persistent | Self-motivated | Cross-Functional Collaboration | Results-Driven | Reliable | Consistent | Proactive | Customer Oriented with attention to detail and quality | Strong communication and facilitation skills.Computer Skills: Microsoft Office Suite: Outlook, Word, Excel, OneNote, PowerPoint, SharePoint, Project | Smartsheet | Lucid | Veeva Vault | Plateau Learning Management | Livelink ECM Document Management | Documentum Content Management | CDD Vault | IDBS E-Workbook | Sci-FinderN | Metworx | Provantis | Dispense | Ascentos | Transend | Patholytix | Waters NuGenesis ELN/SDMS | Waters Empower | Chemstation | STARLiMS Laboratory Information Management System and ELN | Business Objects | Crystal Reports viewer.

Monica Le's Current Company Details
Apellis Pharmaceuticals

Apellis Pharmaceuticals

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Senior IT Business Systems Analyst, Research - IT
Waltham, MA, US
Website:
apellis.com
Employees:
783
Monica Le Work Experience Details
  • Apellis Pharmaceuticals
    Senior It Business Systems Analyst, Research - It
    Apellis Pharmaceuticals
    Waltham, Ma, Us
  • Moderna
    Sr. Business Process Manager
    Moderna Nov 2023 - Present
    Cambridge, Massachusetts, Us
  • Apellis Pharmaceuticals
    Senior It Business Systems Analyst, Research - It
    Apellis Pharmaceuticals Jun 2022 - Oct 2023
    Waltham, Ma, Us
    • Represented IT as the business analyst and technical SME for various research groups and scientific disciplines to bridge the gap between technology and research, resulting in more efficient, effective, and innovative research practices.• Ensured best practices for storage, maintenance, and data integrity to support research objectives, compliance, and collaboration.• Provided cross-functional business process analysis to document, support and optimize various processes including scientific data collection and management, visualization, and analysis to enhance operational efficiency, data quality, and overall effectiveness.• Managed solution implementation, integration and continuous optimization of scientific and lab information technologies and solutions to establish a highly efficient and well-integrated scientific and lab IT environment.• Understood and documented business needs and identifed solutions that aligned to overall business strategies; analyzed, evaluated, and implemented solutions that contributed to the organization's growth, competitiveness, and overall success.• Led business systems consulting, project planning, prioritization, and implementation to improve business processes and contributed to the achievement of strategic goals and objectives.• Developed business technology process documentation to enhance efficiency, reduce risks, and promoted effective decision-making and collaboration across the organization. Documented the system, functional and business requirements, and objectives to align with business goals.• Served as IT Lead/Technical SME for systems, enhancements, and integration projects to support the organization's growth while minimizing risks and ensuring alignment with business objectives.• Oversaw software vendors/service providers to ensure coordination and orchestration of support plans, enhancements, upgrades, integrations, and test activities to maintain service quality, minimize disruptions, and optimize costs.
  • Sanofi
    Its Domain Expert
    Sanofi Apr 2020 - Jun 2022
    Paris, France, Fr
    • Collaborated with the ITS Service Owner, Service Manager, Domain Architect, Project Managers and R&D stakeholders for Preclinical Biology related IT systems and workflows to support and provide efficient and effective IT solutions.• Advised throughout the life cycle (plan, design, build, run) of solutions belonging to Preclinical Biology in partnership with experts at other sites to support the research and operational needs of the organization.• Acted as technical and enforcement authority for solutions belonging to Preclinical Biology. Proposed and contribute to the optimization and implementation of advanced services for Preclinical Biology workflows and solutions. Served as technical SME or as IS project leader to ensure the effectiveness, compliance, and success of IT initiatives.• Provided and guaranteed a broad and strategic vision and understanding of Preclinical Biology Domain solutions and workflows to maximize the value, effectiveness, and impact of IT initiatives.• Provided inputs for selection purpose and/or performance monitoring & improvement concerning Statement of Work (SOW) with vendors and subcontracting partners to achieve successful project outcomes, maintain cost-effectiveness, and ensure that partnerships align with the organization's goals and standards.
  • Sanofi
    Senior Business Systems Analyst
    Sanofi Oct 2010 - Apr 2020
    Paris, France, Fr
    • Global System Owner of STARLiMS.• Planned, designed, developed, and deployed enhancements to the Caducee program (Empower, NuGenesis SMDS, and NuGenesis ELN) to improve efficiency and enhance data management.• Drove best practices through governance, development, implementation, and continuous improvement of standardized ITS solutions and business processes to establish a strong foundation for ITS operations and business processes that can delivering consistent, high-quality results.• Delivered customer-oriented solutions for ITS in collaboration with Business Process Owners to realize maximum value and a strong ROI to the business.• Collaborated with others for effective planning, management, and execution of projects to promote teamwork, and knowledge sharing, benefiting both the organization and its stakeholders.• Performed investigations and resolved reported system incidents to minimize disruptions, protect data, enhance compliance, and contribute to the overall reliability and stability of systems and services.• Created Life Cycle documentation (User Requirement Specification, Functional Specification, Trace Matrix etc.) to improve project management, reduce risk, and better align with user needs.• Created and executed test scripts, change request packages and protocols to ensure the quality, reliability, and compliance of software and system changes.• Evaluated users’ business requirements, present capabilities, and recommended solutions to provide a well-informed, strategic, and tailored approach to address needs and drive positive outcomes.
  • Sanofi
    Quality Control Analyst Ii
    Sanofi Nov 2006 - Oct 2010
    Paris, France, Fr
    Demonstrated meticulous adherence to cGMPs while conducting diverse assays (including HPLC and GC) on raw materials, in-process, and finished products, in alignment with SOPs for product release, validation, stability, and process qualification. Proficiently addressed assay troubleshooting and optimization, consistently ensuring product quality, regulatory compliance, and heightened safety standards. Assumed a key role as the primary trainer, actively contributing to team competence and productivity by crafting and revising On the Job Trainings, SOPs, and Technical Reports. Represented QC at cross-functional meetings, effectively communicating test results and testing progress. Facilitated collaboration between Manufacturing and QC Chemistry, streamlining processes, elevating product quality, and enhancing overall organizational efficiency.
  • Genzyme
    Laboratory Intern
    Genzyme 2004 - 2005
    Paris, France, Fr
    Demonstrated commitment to laboratory excellence through daily reagent preparation, conducting meticulous activity and protein assays across diverse column steps, and executing SDS PAGE for purity validation. Consistently maintained the highest safety standards by strictly adhering to safety policies and procedures. Additionally, played a pivotal role in quality control, conducting a range of QC micro assays, including EM and WFI collection and testing, as well as LAL and Heavy Metals and Nitrates analysis, ensuring product integrity and compliance.

Monica Le Skills

Lims 21 Cfr Part 11 Computer System Validation Gxp Change Control Validation Gmp Sop Fda Biotechnology Pharmaceutical Industry Lifesciences

Monica Le Education Details

  • Boston University
    Boston University
    Chemistry

Frequently Asked Questions about Monica Le

What company does Monica Le work for?

Monica Le works for Apellis Pharmaceuticals

What is Monica Le's role at the current company?

Monica Le's current role is Senior IT Business Systems Analyst, Research - IT.

What is Monica Le's email address?

Monica Le's email address is mo****@****yme.com

What is Monica Le's direct phone number?

Monica Le's direct phone number is +161725*****

What schools did Monica Le attend?

Monica Le attended Boston University.

What skills is Monica Le known for?

Monica Le has skills like Lims, 21 Cfr Part 11, Computer System Validation, Gxp, Change Control, Validation, Gmp, Sop, Fda, Biotechnology, Pharmaceutical Industry, Lifesciences.

Who are Monica Le's colleagues?

Monica Le's colleagues are Dr. Lisa-Marie Müllerleile, Phd, Philipp Wenter, Ian Freeman, Jason Trainor, Maxwell Mulcahy, Phil Weaver, Rhushikesh Phadke, Phd.

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