- Software Developer/Team Lead/Project Lead with 12+ years of experience in the Information Industry.
- Experience with variety of applications including Enterprise level Laboratory Information Management System (LIMS), Chromatography Data System, Financial Derivative System and Interactive Voice Response System.
- Worked with complete ‘Product Development Life Cycle’.
- Worked in the ‘ISO 9001:2001’ Software Development environment.
- Subject Matter Expert (SME) with strong background in developing, designing and maintaining the validated state for global infrastructure based GMP Applications with 21 CFR Part 11 based application design and development. Strong Analytical and Problem solving skills.
- Experienced with working with multiple teams including business users, validation teams, development & support team both ON and Off - shore teams. Worked extensively with multi-level QC based applications in both Project and Functional lead role implementing, supporting and releasing 1 or more releases per calendar year.
- Achieved Six Sigma Yellow Belt and Project Management Professional (PMP) .
- Worked extensively with LabWare LIMS v7, v6 and v5. Worked with various modules including, Lot Management, Stability, Project Manager, Batch Manager and LIMS-Empower Interface, LIMS-SAP Interface.
- Strong development, design and configuration experience with applications like LabWare LIMS v5.0 and v6.0 and Waters Chromatography System like Empower 1 and Empower 2
- Designed, developed and supported both Web based and 3 Tier architecture based applications.
- Oracle 9i, 10 and 11g, Sybase System, MS SQL
- Rational Rose with UML and Visio.
- Windows XP/2000/NT/Window 7 and Windows Server 2003/2008.
- Deployed Waterfall, Agile and hybrid strategies for software development.
Confidential, Newark, DETechnical Lead
- As lead developed, documented and deployment of a database layer use to extract the quality data for Gilead Sciences commercial data to confirm the processes used are in compliance. The collected data is fed to an NWA Charting application which then provides the compliance state of the process.
- Acting lead developer to continuously support Gilead Sciences global LIMS system. It involves understanding the current and upcoming needs, meeting with the end-users to understand requirements and develop functional requirements. Implement the user requirements and working Validation team members to define the test cases/scenarios for the functional requirement testing.
Confidential, Cranbury, NJ
- Architected the distributed design for their LIMS Application across multiple Citrix farms to make the availability of the LIMS system for the multisite usage.
- Deployed a hybrid strategy (both a V and Agile). The waterfall was the overall design methodology that was followed but the design, development and approval of independent module was completed using an agile development methodology
- Designed the application configuration using an object based or a building bloc approach that allowed the subsequent complex object design comparatively easier and based on the putting together of the remaining complex objects setup comparatively easier and individual tested building blocks.
- Responsible for authoring and reviewing the User Requirements (URS), Functional Requirements (FRS) and Design documents for validation purposes.
- Worked with Validation team to put together the strategies to perform an affective Operational Qualification (OQ) for the complete application.
- Worked with the various business teams from both Manufacturing and R&D to design a system that helped to map the Lab workflows for both sites to co-exist and provided by one System.
- Authored the Installation Qualification (IQ) for the LabWare LIMS v6.0 in an Oracle 11g and Citrix based Environments.
- Worked extensively with LIMS-Empower Interface, Lot Management, Stability v7.0, Environmental Monitoring, Instrument Management, Approval Manager and Product Management within LIMS.
- Developed various types of Reports using Crystal Reporting application and integrated the solution with LIMS.
Confidential, Collegeville, PA
- Leading the efforts involved in the migration of Novell IPrint technology to VPSX infrastructure for Confidential ’s LIMS efforts.
- Devised and led developmental testing strategy for the upgrade of LabWare LIMS from Oracle 9i to Oracle 11g.
- Involved in update of LabWare LIMS v5.0 to LabWare LIMS v6.0.
- Led the implementation of Electronic Signature to satisfy predicate rules requirements in corporate LIMS system.
- Led the migration of the LabWare LIMS v5.0-Empower 1 to Empower 2 Interface.
- Involved in the design and implementation of the global infrastructure based GMP application for Wyeth’s manufacturing.
- Authored the LIMS Development Standards an extensive workflow followed by the Solution delivery team devise the solution which smoothed the release process.
- Involved in the setup of infrastructure for their Disaster Recovery solution.
- Designed and implemented a module to create a hybrid report capable of reporting data from their legacy (SQL LIMS) and current LabWare LIMS system.
- Led the Design and implementation of a manufacturing site specific solution to export data from Legacy StarLIMS and to LabWare LIMS to predict the shelf life of the product.
- Highly knowledgeable of 21CFR Part11 and auditing requirements for electronic records
- Involved with integration of the Source Control Manager with the Development Process.
- Collaborated with various groups such as Validation, to maintain the validated state of the application and to provide in the application.
- Worked with multiple (North America, European and Asian) sites to understand their local procedures. Assisted teams in the implementation of various modules of the LIMS Application.
- Consistently worked with Validation group to explain newly developed feature sets provided complete developmental details for use in their OQ Scripts.
- Worked with Business Groups/End User to analyze requirements (URS) and convert these URSes to Functional requirements (FRS).
- Developed ingenious tools for the Support team for troubleshooting their day-to-day issues.
- Worked with Infrastructure Groups (Database and Windows Groups) for their continuous efforts to provide a technological environment which is based upon the latest cutting-edge tools and providing an environment that is available 24X7.
- Developed ingenious techniques and/or tools to upload mass amounts of data to the LabWare LIMS database to expedite the process of creation of Master data.
Confidential, Ardsley, NY
- Involved with the designing and development for Lab Specific workflows e.g., to Approve Lab Objects.
- Developed new Reports using Crystal Report.
- Worked with Quality Assurance group to understand new features and implement them.
- Performed Unit testing and complete documentation of the new features.
- Added Email scheduler to the LIMS application using SMTP server.
- Developed features that are FDA compliant like, 21CFR Part11, automatic Auditing.
Confidential, Princeton, NJ
- Interacting with the Business Manager to understand the business requirements and implement them.
- Implemented the Patriot Act specific requirement related to cross-checking to prevent online transfer of funds to any Illegal Institutions.
- Assisted in the design of User-friendly Web Pages.
- Used ASP, ADO, HTML and Oracle 8i with stored procedure called from ASP pages.
Confidential, Allendale, NJTechnical Lead
- Led a team adding new functionality for storing/retrieving the non-structured data (.doc, image files, crystal report files, data files) to/from database in both Client/Server and Web applications.
- Involved with writing the design documents for the new features following the ‘ISO 9001:2001’ standard guidelines.
- Implemented Web features using ASP 3.0 and Visual Basic 6.0 with Oracle 8i at the backend.
- Involved with writing test-documents and helped the QC department to execute the test protocols.
- Implemented a COM object using Visual Basic 6.0 and ADO for storing and retrieving the unstructured data.
- Integrated the Crystal Report 8.0/8.5/9.0 with Web application. Invoking the .rpt files stored in the database and used the automation model of the crystal report 8.5 to pass the parameters object and displaying the crystal report in Web.
- Developed features that are FDA compliant like, 21CFR Part11, automatic Auditing.
- Used Visual Source Safe to maintain the source code of the application and to release software patches.
- Assisted in writing design documents, coding and testing the software modules.
- Used ATL, Visual Basic 6.0 and Visual C++ 6.0 for writing COM/DCOM objects and Windows Services with Oracle 8i
- Used the Object-Oriented concepts in writing various Business Objects with parent-child and relationship and assisted in designing using Rational Rose and Visio.
- Developed the User-Interface using Visual Basic 6.0 and various 3rd Party controls. Added several application specific user-interface features.
- Participated in the complete Product Development Life Cycle.
- Ported the legacy code to a COM object using ATL.
- Worked on the performance enhancement of the application by merging the complex structures, using late-object-instantiation technique and various programming enhancements.
- Documented the Automation model for the various modules.
- Developed test-suites for the development-team testing.
- Used Visual Source Safe to maintain the source code of 4 major releases of the application.
- Added the VBA support in the application, to facilitate the customized code.