SUMMARY:

LIMS Professional with over five years of experience in laboratory informatics consulting, development, and administration. Experience working in regulated GMP environments within pharmaceutical, biomedical, government and biotech industries. Thorough understanding of laboratory workflows, as well as a variety of managerial and technical skills, with a strong background in LIMS, ELN, and project management.

SKILL:

LabWare LIMS: Skilled at configuring LabWare LIMS (v5, v6, v7, Pharma Template, LabStation), including subroutines, master data, stability, parsing scripts, products, and environmental monitoring within GMP environments. Certified in LabWare LIMS Administration and ELN.

SQL & Programming: Regular use of SQL to query and work with LabWare LIMS, knowledge of advanced SQL techniques and a good understanding of databases. Extensively used Oracle SQL Developer, Toad, and Microsoft SQL Server. Familiar with understanding, interpreting, and testing code - frequent use of LIMS Basic to develop subroutines. Familiar with programming concepts and have a basic understanding of R, HTML, VBA, and Java.

System Validation: Regularly review, unit test, and validate application deliverables including master data, subroutines, upgrades, and new functionality. Knowledge of SDLC, use HP ALM for requirement tracking and writing, running, and reviewing test scripts.

System Integration: Have worked on multiple system integrations, including gathering requirements, process mapping, consolidating feedback and efforts of multiple IT teams, development and deployment. Familiar with EDI, BizTalk, Oracle ERP.

Crystal Reports: Proficient at creating custom reports and optimizing existing ones for use with LabWare LIMS, with a high level of customization based on client or internal requirements.

ELN: Experienced at creating and designing LabWare LIMS Electronic Laboratory Notebook templates.

Instrumentation: Prepare and connect various laboratory instruments to LIMS for direct data collection, familiar with instrument requirements and LabStation parsing scripts.

LIMS: developers, management, and users at all levels to effectively use LIMS, frequently create material and courses.

Microsoft Office/SharePoint: Skilled at using Microsoft Excel, Access, Word, and Visio at an advanced level, including use of VBA and macros.

System Documentation: Experienced in creating and revising system documentation, SOPs, material, validation test scripts, and work instructions. Responsible for documentation of a variety of systems, including application issues, design specifications, user enhancement requests, and user requirements. Familiar with 21 CFR Part 11, Confidential regulations, Good Documentation Practices (GDP).

Requirements: Take a proactive approach to gathering and defining business requirements, as well as tracking the status of requirements and ensuring requirements are correct and satisfy all stakeholders as early as possible in the process. Gather input from various SME’s, harmonize approach or variances between different sites, and track/update requirements from the gathering through development and testing phases.

Laboratory: Strong understanding of laboratory assays, requirements, and workflow.

EXPERIENCE:

Confidential

LIMS Consultant/Developer

Responsibilities:

• Consultant for several projects, primarily government and pharmaceutical clients.
• Have often filled several roles on a single project as well as for multiple projects.
• Skilled at prioritizing multiple responsibilities and completing tasks in parallel for several clients.
• Projects mostly involve working with LabWare LIMS v6 and v7, ELN, SQL, TFS, ALM, Crystal Reports, and Instrumentation.
• Experience with integrating systems; including EDI, BizTalk and Oracle ERP (for invoices, customer information, vendor management, etc…)
• Skilled at managing and mentoring offshore and remote resources, and coordinating the efforts of multiple teams in order to provide effective solutions to clients.

Confidential, Augusta, GA

Programmer Analyst

Responsibilities:

• Provided LIMS expertise, technical programming assistance, and business analysis to the LIMS team.
• Worked primarily with LabWare LIMS (v6, v7), ELN, LIMS Basic, SQL, Crystal Reports, and HP ALM.
• Assisted development efforts as required, including creating and configuring subroutines, reports, master data, templates, and user requirements.
• Was heavily involved in project management, resource planning and client interactions.
• Worked in an Agile environment, using several internally developed tracking and testing tools to organize/manage work and supplement development and testing efforts.
• Used technical expertise to guide process improvements for clients as well the LIMS and QA testing teams.
• Ensured that LIMS master data builds, configuration, and testing was documented and in compliance with internal and client SOPs.
• Mentored team members, providing and guidance.

Confidential, Columbia, MO

LIMS Administrator

Responsibilities:

• As the site LIMS Administrator, handled development, user issues, change requests, documentation, configuration, and implementation of LIMS.
• Primarily worked with LabWare LIMS (v6) and Crystal Reports.
• Also worked with SQL, Electronic Laboratory Notebooks, and Empower.
• Responsible for configuring and supporting LabWare LIMS, handled change requests and user technical issues.
• Identified and addressed concerns in the configuration, workflow design, unit testing, and system validation of LIMS.
• Worked with vendor to resolve issues and add functionality to the system.

Confidential, Orlando, FL

Junior Informatics Associate

Responsibilities:

• Primarily worked with LabWare LIMS (v5, v6), SQL, and Crystal Reports.
• Also worked with Thermo SampleManager and Oracle LabPAS.
• Travelled to client sites to work on LIMS projects with senior consultants and clients in Confidential regulated environments.
• Responsibilities included creating reports, resolving issues, documentation, user, LabWare ELN development, and LabWare LIMS configuration.

Confidential, Bethesda, MD

Biomedical Research Assistant (Intern)

Responsibilities:

• Learned biomedical research and laboratory techniques, and optimized laboratory assays based on study requirements.
• Carried out short term research project, involved applying theoretical knowledge to practical situations and experiments.
• Participated in technical writing and research presentation workshops, shadowed biomedical and clinical researchers, collaborated with scientists and interns on their research projects, and organized research results and data.
• Assisted scientists with research and data analysis, experiment set up, study documentation, and abstract/paper writing.