EXPERIENCE SUMMARY

• Developed LIMS systems based on user requirements.
• SharePoint administration and development
• Senior IT Business Administrator
• Experienced in creating and maintaining project management for computer applications (LIMS), laboratory instrumentation and product life cycle.
• Authored scientific technical reports and protocols, using research and analytical results.
• Executed Oracle database (9i - 11g) administration functions to assist in Crystal Reports (8-XI) development.
• Conducted review of requirements and teh definition of a LIMS implementation strategy, including gap analysis, to construct a system best suited for teh company’s needs.
• Familiar wif Information Analysis and Infrastructure Protection
• Defined and authored user and functional requirements (URS and FRS), created user test scripts utilizing Agile and/or Waterfall model (UAT, OQ and PQ), and assisted in developing score sheets for vendor selection and evaluation.
• Excellent collaboration skills, able to establish and sustain an TEMPeffective working relationship, both wifin & between organization groups.
• Knowledgeable of FDA, GMP, ICH, and other federal regulations and guidelines.
• Experienced in establishing TEMPeffective communication wif internal and external customers.
• Outstanding analysis, leadership, presentation, and communication skills.
• Excellent computer validation skills compliant wif 21CFR Part 11. Recognized subject matter expert (SME) in LabWare and STARLIMS laboratory information management systems (LIMS).
• Software Development
• User and functional requirements (URS and FRS) identification
• Systems Administration (LIMS)
• Data script writing (Vendor selection, UAT, OQ and PQ)
• System Product Life Cycle (IQ, OQ and PQ)
• Software application testing (ISPDM)
• Manage concurrent system users
• Certified Crystal Report Developer
• Data Analysis
• Business Administration

TECHNICAL SKILLS

Software/COTS: LabWare LIMS, OpenLab (ELN & ECM), StarLIMS, Data Management Systems (Empower, Millennium, etc.), Data Science Tools (Geneious, Spotfire, Flow Jo), MS SharePoint, Crystal Reports, Oracle, TOAD, SQL Developer, MS Office Suites, Lester, Lotus Notes, MS Project and MS Visio

Programming Languages: SQL, Java, LIMS Basic, XML, HTML and Microsoft Visual Basic

Operating Systems: Windows

PROFESSIONAL EXPERIENCE

Senior Manager, Software Applications

Confidential, Germantown, MD

Responsibilities:

• Manage 4+ technical team
• Created and maintained software budget for Health division
• Administer and manage 100+ users for data sciences and informatics software
• OpenLab ELN and ECM
• SharePoint developer
• Software Developer
• Lead LIMS vendor selection and program management
• Assess business requirements for Informatics and propose solutions
• Author technical documents for business case
• Crystal Reports development based on user’s requirements
• Responsible for infrastructure build, test, and implementation
• Technical site lead for Electronic Data Management System
• Software representative for Internal PMO Team

Sr. LIMS Developer

Confidential, Bethesda, MD

Responsibilities:

• Sr. Starlims LIMS Developer
• Lead Crystal Reports Developer
• LIMS Developer based on user’s requirements
• Configured Starlims forms and applications
• SSL Development
• Developed Starlims workflows
• Crystal Reports development based on user’s requirements
• Author LIMS and IT technical documentation
• Work Procedures and System Design documentation
• Responsible for infrastructure build and implementation

Sr. LIMS Administrator

Confidential, Bethesda, MD

Responsibilities:

• Sr. LabWare LIMS Administrator
• SharePoint administration
• LIMS Developer
• Crystal Reports development based on user’s requirements
• Author LIMS and IT technical documentation
• IQ, OQ, PQ, UAT and System Design documentation
• Responsible for infrastructure build and implementation
• Serve as project manager
• Set timeline and deliverables
• Coordinate resource plan/schedule

LIMS Developer

Confidential, MD

Responsibilities:

• LabWare LIMS Developer
• Sr. Reports Developer
• LabWare v5 to v6 upgrade
• SharePoint administration
• Data migration using Pearl Scripts and LW methodology
• Create Crystal Reports based on User requests
• LabWare and SAP integration
• Beckman LIMS Administration
• OpenLab Administration
• LabWare LIMS Administrator
• Manager 30+ concurrent users
• Author LIMS and IT technical documentation
• Responsible for infrastructure build and implementation
• Serve as project manager
• Crystal Report migration
• MS SharePoint development
• Authored comparison documents (DAR) for interoffice document sharing platform
• Confluence and Alfresco developer

Otsuka America Pharmaceutical, Scientist

Confidential, MD

Responsibilities:

• Certified Laboratory Information Management System Administrator
• Manage 5-15 concurrent LIMS users.
• Served as teh Crystal Reports developer for data reporting.
• Utilized Oracle administration functions to assist in report development, LIMS configuration and system maintenance for quality data.
• Responsible for designing demonstration user scripts and score sheet evaluation for targeted LIMS vendors.
• Responsible for LabWare LIMS Installation Qualification (IQ), Operational Qualification (OQ), and Production Qualification (PQ).
• Develop scripts for User-Acceptance-Test, Operational Qualification (OQ), and Production Qualification (PQ).
• Conducted software application (LIMS) testing utilizing teh waterfall model and Black Box strategy.
• Demonstrate successful user management of LIMS project, including scope and schedule goals.
• Provide technical advice, project coordination and LIMS project management to support team.
• Assisted wif user and functional requirements gathering and documentation to comply wif company priorities
• Author QC documentation, including stability reports and protocols, using results from contract laboratories ensuring efficient product testing.
• Monitor stability studies of pharmaceutical products tested by contract laboratories.
• Perform internal and external audits of contract laboratories.
• Execute method validation and method development to support R&D and stability pharmaceutical testing.
• Review, enter, and maintain stability data for pharmaceutical products.
• Active contributor to teh planning and analysis of experimental protocols.
• Create and maintain Excel stability template and tracking system utilizing Visual Basic.
• Coordinate analytical testing of pharmaceutical products.
• Train all users on LabWare LIMS software and Excel templates.

Sr. Research Technician

Confidential, MD

Responsibilities:

• Skilled at performing Gel Electrophoresis, SDS-Page, UV/VIS, HPLC, MS and Light Scattering (Interferometric Refractometry).
• Active contributor to teh planning and analysis of experimental protocols.
• Worked independently to perform set-up, execution, and summarize findings for experimental procedures.
• Excellent time and data management skills.
• Experience working wif FDA protocols and following USP and GMP specifications.
• Developed assays for chemical analysis of new drug formulations.
• Performed HPLC, LCMS, UV/VIS, Dissolution methods, calibrations, and computer validations.
• Aided in teh training of new employees wif LIMS, HPLC, and Dissolution methods.
• Executed SOPs to ensure efficiency and accuracy in method development.
• Conducted various analytical testing (me.e. raw materials, composite assay, related compounds, content uniformity, and blend uniformity) using various procedures and laboratory instruments following FDA and GMP guidelines.
• Skilled at performing HPLC methods, calibrations and computer validations.
• Developed and executed qualification protocols for computerized systems, me.e. Waters Data Acquisition system.
• Knowledge of computer validation methodologies, software development life cycles, and change management systems.