SUMMARY:

• Executed IQ OQ, PQ scripts.
• Responsible for interpreting and documenting current state and future state business processes in an effort to assist with migration and implementation of Lab systems and LIMS software.
• Responsible for development and implementation of LIMS applications in compliance with Quality standards (GLP, GMP, GAMP and 21 CFR Part11) and maintain customer relationship
• Responsible for creating Job Aids, SOPs, and other required documents to move the changes from validation to production.
• Responsible for onsite implementation, rollouts, cutover and manage the project from start to go - live.
• Responsible for creating change requests in CR system and approve them as required.
• Managed Tier 1,2 and 3 tickets in IT support systems.
• Lead cross-functional teams, testing teams, lead developers to ensure the delivery on time and budget,
• Hands-on and Extensive experience in databases likes Oracle, MS SQL Server, MySQL MariaDB and Technologies like PHP, ASPX, ASP, Net, VB, Java
• Saved over $ 6M in recovering various complex projects that were in jeopardy of being lost due to bad design and execution.
• Traveled extensively to clients place for, troubleshooting, technical discussions, and support during all phases of development, staging and go live.
• Conducting sessions with large groups of individuals consisting of Business Analysts, Subject Matter Experts and Process Owners from cross-functional areas to gather information and complete documentation of As-Is and To-Be business processes.
• Performing analysis of information and completing documentation of complex business processes using Microsoft Visio.
• Identifying gaps between current and future state business processes for customization of software.
• Presenting process analysis and process improvement solutions to the senior management.
• Developing user and technical documentation for software application and database.
• Manage all phases of the LIMS software development life cycle including coordinating of resources, development of design specifications from business requirements, cost estimation, standards, release management, software change management and code compliance.
• Hands on experience with Labware LIMS systems, Lab Station, integrating Empower 3
• Designed and developed Inventory control for Control substance in Labware (Custom solution)
• Designed and developer Instrument service request module in Labware ( Custom solution)
• Extensive experience in all the modules of Labware systems.
• Designed and developed sample storage location software for quick check-in and checkout process using electronic signature eliminating paper check-in and checkout
• Designed and developed several crystal reports, monthly reports. Developed custom dashboards which help supervisor to assign workloads to analysts.
• Closely worked with Micro lab scientists to develop micro sample testing workflow and components
• Worked closely with tech writing to configure product specifications.
• Hands on experience in creating pages and coding custom pages using Sapphire EverGreen version Sapphire R4.1 to Sapphire 4.5, DM0203.x.x to DM0206.x.x
• Extensive experience in designing and developing Java classes using Confidential Sapphire architecture such as AddSDI, Edit SDI, DeleteDataItem etc.
• Hands on experience in previous versions of sapphire 3.x and Confidential 6
• Configured LIMS systems using Confidential Explorer (LVX - All versions)
• Coded and Developed applications using Jaguar EASever 5.2 and Sapphire R4.4 (Opal - PM0401) and UDM- PM0401)
• Extensive experience in solving performance issues both on Oracle and SQL server.
• Developed custom maint elements for customer needs using EverGreen Frame work.
• Upgraded Application Server (Jaguar) and several Sapphire client systems and migrated to the latest version of Sapphire R4.4 and R4.5
• Designed and developed custom data model to fit customer requirements on top of Sapphire core data model.
• Implemented sapphire SOM and LIMS link to read instruments. Developed instrument interfaces using Java and VB to communicated to Sapphire Data Model
• Good knowledge of Paramlist, Paramid and configuring Specifications to check on the data entry page.
• Involved in developing Sapphire BioBanking and implemented and trained clients and users.
• Resolved performance issues in Data Entry pages, List elements and SDI detail maint elements.
• Designed and coded java scripts and executed via Action buttons in Ever Green. Created Roles and maintained roles on sitemap tramline, buttons, and pages.
• Created workflows, tasks, queries using LVX.
• Wrote java scripts and executed via Action buttons in Ever Green. Created Roles and maintained roles on sitemap tramline, buttons, and pages.
• Developed Business objects reports using BO 6.1 and 6.5. Configured Adhoc reporting and integrated with Bo Web Intelligence Server. Good working knowledge of Apache, Tomcat and Web servers.
• Hands on experience in upgrading LIMS system and migrating LIMS applications such as Sample manager, SQL*LIMS V4, v5, web J2EE based application, SQL*Stability, STAR LIMS to sapphire LIMS.
• Demonstrated success in managing complex and dual shore projects. Strong problem analysis and problem-solving skills. Comprehensive experience in IT project management, Global LIMS Implementation, Bio-Informatics Applications, Array management, SDLC, validation, activities, customer relationship and sourcing management. Strong traditional LIMS knowledge, Good exposure in all kinds of Sample Life Cycle both traditional LIMS and Life Sciences LIMS, Audit Tracking, Requirements Gathering, Requirements Analysis, Functional Specification, Systems Design, Software and Module Design & development. Good reporting knowledge using Business Objects, Crystal reports, and JReports.
• IT professional offering 20+ years of IT experience in validating & implementing large - scale Lab Systems, LIMS, ELN, IT Systems validation, project management, migration, requirements definition, planning, analysis & design, full system lifecycle development, testing, and quality assurance (Meeting 21 CFR part11, Electronic Signature and FDA requirements). Designed, Developed and Technical project managed several multi-million dollar system integration projects worldwide in the area of Lab Systems & LIMS in Pharmaceutical, BioScience & Food industries. Designed and Implemented complex projects using Sapphire LIMS, LabWare LIMS, Microsoft, ASP.Net, VB, Small talk and Java / JSP technologies with Oracle, PL/SQL, and SQL Server.
• Validation of LIMS, ELN and Lab Systems, Empower, Instruments, Parsers and other IT computer Systems. Overseeing planning, delivery and managing Lab and LIMS/ELN implementations across the globe, buildings/units, and states. Program management driving agile transformations, Professional services, and Outsourced software development & selling Extensive experience in risk management, budgeting, sourcing, project planning and financial forecasting for the IT projects. Directly reported to stakeholders (Directors, CEOs and CTOs) and executives. Hosted PMO meetings to keep project stakeholders informed about the project progress. Responsible for the overall success of the lab and LIMS systems across all units like R&D, QC, Stability, Sales etc. Integrated third party software such as CRM, Salesforce, Instrument interfaces, Ordering systems - Process driven program and delivery management for IT engagements involving multiple and complex technologies. - Lead several in-house IT software development projects and implemented Commercial Off-The-Shelf (COTS) products in the QC lab and R&D Labs. - Involved in Solution building, Engage Management, Delivery Management, IT and Lab Support Management including Tier 1, 2 and 3 levels. -Extensive programming, coding and configuring knowledge in areas such as sample management, Stability module, Inventory, Instrument interfacing, defining instruments, HPLC, Empower Lace systems, integrating LIMS with Empower 3, LIMS Link, Lab Station Extensive experience in reporting tools like Crystal reports, Jasper reports. Strong problem analysis and problem-solving skills. Comprehensive experience in Web development, Tech support, Global rollout, SDLC, validation, activities, Offer outstanding talents in developing project scope (budgets, timelines, delivery dates, and forecast), customer relationship, cost avoidance, continuous design improvements, conducting status meetings and customer reviews.
• Certified Labware LIMS, Confidential / Sapphire LIMS professional and trained to validate, implement and administer global LIMS and ELN solutions. Having been in the customer-facing roles right from the beginning of the career, my experience spansacross Research & Development, Manufacturing and Professional services domain.
• Extensive working experience with Databases like Oracle, SQL Server, MySQL, MariaDB, Amazon AWS and other Cloud systems like AZURE, Sharepoint
• Here is a list of few projects where I was directly involved in coding, validation & implementation, supporting and trouble-shooting Lab Systems and LIMS, ELN applicatio
• Lead small and large teams for software developers, support technicians across business units to implement LIMS and ELN lab systems.
• Involved in all stages of validation of IT LIMS systems. Wrote Validation master plan, Risk assessment, UFRS, 21CFRPart11 Assessment, IQ, OW, PQ, Traceability Matrix, Cutover Plans and Vendor assessment

TECHNICAL SKILLS:

Languages: C, C++, Java, Visual Basic 6.0, Embedded Visual Basic, VBScript, JavaScript. PL/SQL, LIMS Basic, Access routines, LIMS Basic Functions

Web Technologies: ASP 3.0, ASP.Net, JSP, HTML, DHTML, CSS, XML, XSL, AjaX, PHP, Python

Middleware/App Servers: MSMQ, MQ Series, MTS, COM+, IIS, Sybase EA Server, Jaguar Server, Tomcat, Apache, Web Intelligence Server, iPlanet, AvantGo

Third Party Applications: Labware Ver 5 and 6, SQL LIMS, SAMPLE MANAGER, WATSON LIMS, Eroom, Documentum, Doc Basic, NWA Charting - Both Client and Active X. Sapphire R4, Opal, Safe Data, Artemis Views, LIMS Link, Recrystallize Pro, Sharepoint CR system, Service Now. Clarity, Master Control.

Databases: DB2, MS SQL Server, Oracle, MySQL & Access

Operating System: Win 2000, NT4.0, XP, SUN-Solaris, HP-UNIX, Windows CE

IDE and Related Tools: MS Visual Studio 6.0, MS Visual Interdev, Macromedia Dream weaver, Microsoft Visual Source Safe, RCS, PVCS, ANT, IDEA, GEL

Third Party Tools: Toad, POI, ASP Upload, iText

Other Tools: Rational Rose, Erwin, MS Visio 2000, MS Word, MS Excel, MS Project, MS PowerPoint, Adobe Photoshop Macromedia Fireworks, Macromedia Flash, Win Runner, Silk Test.

Reporting Tools: Business Objects 6.x, Crystal reports, JReports

Hardware: Desktop Microcomputers, Pentium, Sun Solaris

PROFESSIONAL EXPERIENCE:

LIMS Consultant

Confidential, Morphoek, PA

Responsibilities:

• As a consultant, I am involved in leading, planning, designing and developing Lab and LIMS & ELN systems for R&D and QC Labs.
• Created custom protocols and workflows in BIOVIA Pipeline Pilot - Data science tool. Created web service and deployed internally. Customized reporting of bio sequence.
• Extended BIOVIA PP and integrated to internal MS SQL Server database to pull Assay Results.
• Created workflow using biological database and Chemistry database. Extensive experience in checking patents.
• Helped scientist by integrating silo scientific data across business units and made shareable internally.
• Wrote Validation master plan, Risk assessment, UFRS, 21CFRPart11 Assessment, IQ, OW, PQ, Traceability Matrix, Cutover Plans and Vendor assessment
• Designed, developed and validated custom solutions and saved several million dollars for the company.
• Closely worked and lead teams, programmers to ensure timely delivery of software modules.
• Closely worked with vendors to resolve issues.
• Worked closely with QC lab, Micro Lab and Stability Labs and Research scientists to develop product solutions to enhance their daily job routine for smooth operations.
• Developed several parsing solutions to parse data from instrument into LIMS system
• Handled support tickets and managed effectively to ensure smooth operation of the lab.
• Handled Change requests, drafting Job aids, SOP, and other required documents.
• Involved in integrating third-party software into LIMS
• Harmonized several IT software apps and developed VB.Net solutions to support Lab functions.
• Created several crystal reports to meet business requirement
• Involved extensively in writing and debugging Subroutines, enhancement requests. Resolving OQ and script execution issues
• Wrote IQ OQ PQ documents. Executed validation scripts.
• Developed custom software for Inventory and Instrument Service requests.

LIMS Consultant

Confidential

Responsibilities:

• Wrote Validation master plan, Risk assessment, UFRS, 21CFRPart11 Assessment, IQ, OW, PQ, Traceability Matrix, Cutover Plans and Vendor assessment
• Involved in various capacity to provide solutions,design, development and support, validate LIMS and Lab systems
• Involved in developing custom storage solutions to store biosamples
• Involved extensively in writing Unit Test Scripts, User Acceptance testing.
• Involved in gathering requirements from sites in NJ and other business units.
• Wrote detail FS documents, UAT documents for the entire project

LIMS Consultant

Confidential, Irvine, CA

Responsibilities:

• As a Labware IT consultant, I am involved in designing & customizing solutions using LIMS version 5 and 6, Stability 7 using Pharma template, an inventory module, Lot management, Environment module, Stability reports, and Trending reports.
• Gather requirements and configuring Labware LIMS to meet business needs.
• Involved in converting Thermo LabManager LIMS to Labware lims. Analyzed and discussed with users to understand the existing functionality of the thermo LIMS and reproduced the functionality in Labware LIMS.
• Created similar reports in Labware to meet the existing LIMS requirements.
• Involved extensively in writing and debugging Subroutines, enhancement requests. Resolving OQ issues
• Involved extensively in writing Unit Test Scripts, User Acceptance testing. users to use Labware Application, Chart module, Reports
• Involved in gathering requirements from sites in Brazil, Ireland & 2 sites in North America
• Involved in programming NWA SPC Charts using Labware NWA SQC Module, Involved in gathering requirements for Empower interfacing.
• Wrote detail FS documents, UAT documents for the entire project
• Involved in helping QA to finish Validation tasks. Created Change control documents and objects to move objects from Dev to validation and to production
• Created complex reports using excel macro, SLIM Stat and Sigma plot.

LIMS Consultant & Support Consultant (Labware and other Lab Systems)

Confidential

Responsibilities:

• Lead a support team to handle Tier 1,2 and 3support tickets.
• As a LIMS Consultant, I was involved in designing solutions using Labware Andev LIMS and RLIMS.
• Involved in implementing ELN for Research lab
• Drafted and finalized validation master plan, Risk assessment, UFRS, 21CFRPart11 Assessment, IQ, OW, PQ, Traceability Matrix, Cutover Plans and Vendor assessment
• Created several Crystal reports for LIMS and Lab Systems
• Involved in harmonizing LIMS to one product across the company
• Migrated Stability 6 to Stability 7. Matched and re-programmed all the requirements from old system to new system
• Involved extensively in debugging subroutines. Created complex PL/SQL queries to meet requirements
• Supported and Resolved Support tickets. Involved in implementing Change control
• Wrote and updated FS documents, UAT and Unit test scripts
• Executed Test scripts and support Validation tasks
• As a LIMS Consultant, I am involved in programming, configuring, and gathering requirements to meet Business Needs.
• Trained Cognizant employees to take over AnDev LIMS support

LIMS Implementation Consultant

Confidential, WI

Responsibilities:

• As a LIMS Consultant, I have involved programming, configuring, and gathering requirements to meet Business Needs.
• Wrote FS documents, Support LIMS Admin and trained employees to take over the LIMs application
• Wrote unit and validation test scripts. Executed them and helped QA to accomplish their validation tasks. Created prerequisites for running test scripts.
• Validation master plan, Risk assessment, UFRS, 21CFRPart11 Assessment, IQ, OW, PQ, Traceability Matrix, Cutover Plans and Vendor assessment

Software Engineer / Technical Project Manager Development

Confidential, Bridgewater, NJ

Responsibilities:

• Responsible to code, configure, migrate and upgrade LIMS applications.
• Migrated SQL* LIMS, Labware Lims to Sapphire LIMS. Upgrade several customers to latest lims. Addressed tons of issues during the upgrade process.
• Involved in creating the Sapphire LIMS product
• Evaluated different LIMS products, third-party tools for acquisition and mergers
• Extensively worked on Oracle forms and PL/SQL. Created tons of Oracle procedures, Triggers and Views to accomplish complex requirements
• Worked in product development team as a programmer and left Lab Vantage as Manager, Development for further prospects and exposure.
• Involved in implementing LIMS application for various clients for Confidential .

Confidential, NJ

Implementation Consultant

Responsibilities:

• Designed and Implemented LIMS system at Engel Hard Corporation.
• Involved in Artemis project and ASP / Oracle Application and lead team of 7+ professionals at TCG and implemented at Confidential Pharmaceutical - CT
• Designed and Developed Business Objects Reports and Data cubes for entire system
• Implemented Artemis Active Alert product (Oracle PL/SQL), customization and migration projects.
• Design, develop, support and maintain software applications in ASP / Oracle, SQL Server and Visual Basic. Perform data analysis and propose solutions to maximize customer resources. Interpret and present data analysis in oral and written format to senior level management and customers.
• Provide support for homegrown ASP LIMS projects.
• Involved in writing validation master plan, Risk assessment, UFRS, 21CFRPart11 Assessment, IQ, OW, PQ, Traceability Matrix, Cutover Plans and Vendor assessment

Confidential, NJ

Implementation Consultant

Responsibilities:

• Involved in programming and implementing LIMS system.
• Implemented Documentum 4I as their enterprise-wide standard for Document management for complying with FDA regulations including 21CFR Part 11 mandatory regulations. Actively involved in analysis, Design, development and coordinated with Validation analysts
• Project managed Visual Basic / ASP / Oracle / SQL server applications