SUMMARY:

• Inspire, create, teach, mentor, and lead teams to further the needs of the enterprise.
• Demonstrate expertise in developing and leading top - performing teams to align work performance with business needs and requirements.
• Excel at managing and directing teams and departments to motivate use of in-depth knowledge of cutting-edge tools and methodologies, while adhering to industry standards and best practices.
• Possess outstanding ability to create and integrate technical solutions to drive operational efficiency and productivity.
• Exemplify effectiveness in collaborating with other professionals, coupled with capability to adapt to and function well within critical and fast-changing environment.

AREAS OF EXPERTISE:

Problem Identification and Resolution | Teaching and Coaching | Continuous Process Improvement | Enterprise Resource Planning (ERP) System Management | Oracle Applications | Regulatory Compliance | Resource Management, Quality Management Systems (QMS) | 21 CFR Part 11 | DG & MDM | iPaaS & ESB| Databases, Data Normalization & Data Modeling | Business Domains (Clinical, Regulatory, Manufacturing, Finance, Quality Assurance, and Human Resources)

TECHNICAL ACUMEN:

• Visual Basic .NET 2005, 2008, 2010
• ASP.NET
• Crystal Reports
• Oracle PL/SQL and SQL*Plus
• Oracle 9i, 10g, 11g, 12c
• TOAD
• Oracle SQL Developer, PL/SQL Development
• Microsoft Transact-SQL
• Microsoft SQL 2000, 2005, 2008, 2012
• Microsoft Report Services
• Windows Scripting
• Linux Shell Scripting
• MuleSoft Anypoint Studio and Management
• Spreadsheet Server
• Java Scripting
• VBA Scripting

RELEVANT EXPERIENCE:

Confidential, Malvern, PA

Director, Enterprise Information Systems

Responsibilities:

• Continue to develop EIS department and team started as a consultant and manager.
• Continue the role and responsibilities of Manager position.
• Strategic planning, change management, process improvement initiatives.
• POMS implementation team and lead integration design and architecture.
• Creation of Data Governance and Master Data Management plans and process.
• Selection and implementation of iPaaS / Enterprise Service Bus (ESB).
• Change leader and multi-department facilitator of ideas and problem solving.
• Developed and managed the Electronic Initiative Committee comprised of cross-functional professionals tasked to oversee new applications and technology integration to improve all areas of the organization.
• Enhance department to support needs of organization by Creating new roles for a Manager of Business Systems, QMS analyst, Scientific Systems Analyst, Master Data Management Analyst, iPaaS/ESB team.
• Absorb Salesforce.com and FSE applications from new organization to support, enhance and improve functionality.
• Absorb LIMS and ELN projects from 1 department owner to bring functionality to the Enterprise.
• Removal of custom and one-off applications by utilizing and leveraging existing ERP, QMS and Clinical functionality.

Consultant / Manager of Business Applications

Confidential

Responsibilities:

• Earned selection from the senior leadership to build a Business Application Development and Support Team to address IT needs of a growing manufacturing company.
• Build Enterprise Information Systems group from the ground floor: Business Analysts, DBA, and Developers.
• Oversee the development of Oracle E-Business Suite application, user support, daily functions of DBA Team, and implementation of a new functionality and modules: ASC, OPM, Financials, HRMS, Endeca, Supply Chain, OM.
• Serve as project manager for all Oracle upgrades, from 11.5.9 to 12.1.3, including organizational project management (OPM) to core migration and mapping for Oracle EBS R12.
• Observe strict adherence to software development life cycle (SDLC) procedures in creating user requirements for new enterprise applications.
• Display solid leadership and technical skills in overseeing application development for in-house quality process application and corporate database servers design and implementation.
• Lead and participate in application design, database design, and custom development projects to coordinate with COTS integration and extensions for enhancements.

Confidential, Douglassville, PA

Founder, Owner, Integrator

Responsibilities:

• Custom application development in different industries: Engineering, CRO, Medical Device, Pharma, Financial, Education, Construction, Chemical, Petrochemical, Paper, Insurance, Legal.
• Custom database development, data modeling and database design.
• Creation of a new IT department for new division starting with no in-house IT personnel: hired managers, managed network and server installation teams, installed ERP, QMS, and MS Office systems.
• Directed the operation of a software development and integration company, with specialization in manufacturing and financial applications, including Microsoft SQL and Oracle DB consulting services.
• Performed Oracle E-Business migration, from 11.5.3 to 11.5.9 and 11.5.9 to R12.
• Oracle EBS enhancements through built in functionality: Customer Concurrent Manager functions, PL/SQL, and FF.
• ESB and data warehouse integration.
• SAP data migration mappings from multiple legacy systems.
• Oversaw remote DBA, developer, and outside resources involved in the Oracle EBS configuration and customization.
• Participated in rewriting batch records for production and standard operating procedures (SOPs) for IT practices spanning disaster recovery, good manufacturing practices (GMP) packs, and SDLC.
• Steered efforts in integrating applications in various areas of customer applications which involved manufacturing, quality assurance (QA), quality control (QC), regulatory affairs, customer service, and clinical affairs.
• Led the software selection teams in choosing software for Manufacturing, Quality Assurance, and CA departments, as well as to design data migration plan.
• Executed design and implementation of Oracle and MS SQL hot backup methodology; database cloning procedures between validated application instances; and database backup and recovery testing for GMP.
• Created and instituted data model for database-centric applications in Oracle 9i, 10g, 11g, and MS SQL.
• Expertly used integration services in automating the importation of data from external applications for report development.
• Collaborated with various companies in designing in-house applications and purchasing COTS in accordance with user requirements.
• Piloted the integration of first PLC-based equipment monitoring system for a medical device company.
• ESB integration between Salesforce.com CRM, ERP, and custom application utilizing IBM Cast Iron. iPaaS ESB with API first microservices approach between Salesforce.com, CRM, ERP, QMS and MES.
• Data Governance and Master Data Management enforcement and initiatives.
• Custom data store for centralized reporting model.
• Project Manager, Technical and Design Lead.
• Implementation, integration, custom development, migration and upgrades for numerous ERP systems including MCBA, Exact Max, Macola, SAP, MS Dynamics, and Oracle EBS.
• Formulate data migration and application migration plan from vendor documentation to map of data migration.
• Partner with DBAs and Functional Analysts in debugging issues, identifying patches, and migrating and patching scripts.
• Created T-SQL and PL/SQL code to resolve functionality gaps and work-arounds for custom solutions.
• Utilize .NET in developing new code to bridge functionality gaps and work-arounds for custom solutions.
• Conduct manufacturing resource planning (MRP), Supply Chain and Financial module analysis to ensure alignment with analyst, DBA, and implementation and business requirements.
• Lead Application and Database Analyst/Designer/Developer.
• Exemplify strong technical competency in designing and developing in-house batch record application.
• Render keen oversight to the Implementation Team in carrying out validation and data migration verification, along with documentation and qualification for Food and Drug Administration (FDA) validation.
• Lead accountability in developing VB.NET, Crystal Reports, and Oracle PL/SQL.
• Employ solid knowledge of object-oriented design and programming in creating the application to interface with Oracle Applications OPM tables.
• Integrate data batch records lot numbers, expiration dates and customers with Confidential .
• Made use of pessimistic database connection model and database development design that brought reduction in down-time, application errors, development time, and validation efforts.
• Develop requirements, justification and ROI for MES and eBRS.
• Successfully present first MES and eBRS in the global structure to global executive committee for approval.
• Lead selection team to evaluate and choose MES and eBRS solution. Present methods to Global IT group in Japan.
• POMS Implementation team lead for IT, databases, and ERPi integration.
• Lead team to evaluate and select first PLC based data collection network and WonderWare solution.
• Recruited cross-functional team and led a committee in charge of creating justification and user requirements for EDMS evaluation.
• Executed wide-ranging research to identify appropriate vendor to meet EDMS requirements, including negotiation of terms, contract, and agreements.
• Devised and implemented comprehensive project plan in collaboration with internal project team and vendor project team.
• Develop procedures to move data from 3 instance methodology (development, validation and production).
• Design routes, workflows and approvals.
• Design data mapping to build document library vault.
• Designed and developed previous in-house Document Management solution tied to in-house batch record system.

Confidential

Responsibilities:

• Requirements Gathering, Selection, Implementation, Data Migration/Qualification
• Collaborate with Clinical Affairs department to create User Requirements for Biobanking, Sample Management and EDC LIMS system.
• Create Functional Requirements for Sample Management and EDC LIMS system.
• Key stakeholder for selection and implementation of Freezerworks (Dataworks) LIMS Biobanking software.
• Key stakeholder for selection and implementation of LabVantage EDC LIMS.
• Lead technical analyst for data importing into Biobanking, Sample Management and EDC LIMS.
• Participated in validation efforts in all phases of IQ, OQ and PQ.
• Developed queries and reports for LIMS analytics and data verification.
• Write and conduct vendor audit to qualify Freezerworks/Dataworks.
• Participated in vendor audit to qualify LabVantage.
• Performed interviews and participated on selection team to choose LabVantage integrator.
• Developed algorithm for key business requirements including aliquoting, freeze-thaw cycles and sample-centric design to fit user needs.
• Lead team to evaluate and select Electronic Lab Notebook (ELN) solution.

Confidential

Responsibilities:

• Requirements Gathering, Selection, Implementation, Data Migration/Qualification
• Participate on team to create user requirements and evaluate vendors for purchase of CAPA system.
• Develop reports and analytics for Confidential .
• Lead technical analyst and DBA to implement Trackwise - includes role in 2 major version upgrades.
• Participate in global roll-out of CAPA to parent company.