Harivenkatesh Radhakrishnan

http://linkedin.com/in/harivenkatesh-radhakrishnan-2071321/

adtpba@r.postjobfree.com 732-***-****

QUALIFICATIONS PROFILE

Technical Expertise - Technically astute and results-focused management professional with proven success in leadership roles in analysis of business requirements to design, support, and lead IT projects for strategic system solutions in a regulated pharmaceutical, healthcare, or biotech environment. Lifelong learner adept in ability to learn advanced technology and new concepts quickly to maximize organizational success.

Customized Applications – Lead development of application software, management of CRM, ERP systems, production planning, manufacturing, material management, system analysis, resource tracking, and delivery of high quality custom business applications.

Regulatory Compliance– Ensure compliance with multiple regulated systems in biopharmaceutical companies requiring adherence to FDA, SOX, GXP, CS, 21 CFR part 11, SOP and other state and federal regulations.

Staff Leadership & Collaboration – Skilled communicator with strong interpersonal abilities to develop rapport with internal and external customers, business and technical users, and management to provide report documentation and convey complex information in understandable terms.

CORE KNOWLEDGE & SKILL AREAS

Pharmaceutical experiences Stem cell bank background Clinical product studies background Chemical Inventory Management ERP, CRM, LAB systems Aero Space repair & overhaul Asset/Risk Management Analytical & Quantitative Skills IT background Software Development Life Cycle (SDLC) Scrum Agile Waterfall methodology & etc.

TECHNICAL SKILLS

Software & Languages: Perl, Unix Shell scripting, Microsoft Excel VBA, VB, PB, C#, XML, C, C++, SQL, HTML, Microsoft Visual Studio .NET, Business Objects, Crystal Reports, PL SQL, Oracle forms and Reports, J developer, Developer 2000, Pro*C, Java, J2EE, EL-program, Solution series S7 2.5/3.0, SalesLogix, StemLab, Solomon, Siebel CRM, ChemCart, LIMS, SAS and PC SAS, iOffice, Big Data tools and software, FTP & SFTP.

Databases: SYBASE, ORACLE, SQL SERVER, MS Access, Mango, Apache Hive.

CRM & ERP Tools: Veeva Salesforce, Saleslogix, Sibel CRM, Oracle, Impresa, Just In Time-JIT

Data warehouse Tools: Oracle warehouse builder, Oracle Designer and Informatica.

Case Tools: Oracle Discoverer, Erwin.

Other Tools: SQL*PLUS, Share Point, Sub Version. SQL Navigator, Change control, Release management, Quality Control, ITIL, Service Now & Help desk

Operating Systems: Windows, UNIX, LINUX, SOLARIS

Management Tools: MS Office, MS Project, MS Visio, PowerPoint

Software Development & Professional Experience

Eisai, Inc.

Sr. Project Manager Jul 2020 – Till date

Oncology: Project Plan, scope, design, resource scheduling, cost management, requirements, test cases, integrate, validate, deploy management and documentation management for multiple application.

Study Migration: Migrated legacy system study data to latest build SAS environment, which includes project plan, resource, data mapping, file transfer, change control, accounts, study partners & sftp setup, UAT, validation deliverables, vendor management, QA/QC tasks. (MS Office 365 / Project)

Upgrade ECCE/ SAS M7/ Pace/ Jira: Upgrade and delivered ECCE 1.2, SAS M7, Pace 4.1.2 and Jira platform in-house build software. Project management activity & tasks. MS office 365, Service Now, DocuSign, Jira, Varonis.

Merck (http://www.merck.com)

Lead Jan 2020 – Jun 2020

Documentation Management System: Plan, design, requirements, validate, test cases, integrate, deploy the documentation management system for multiple application.

Intercept (http://www.interceptpharma.com)

Sr Architect / Sr System Analyst Oct 2018 – Jun 2019

HR & Facilities: Provide IT solution to the HR depart from hiring till retirement process, which involves design, planning, requirements, develop, configure, test, implementation, deliver onboarding to retirement stages for the HR systems/ technology. Enhance/maintain data quality in the Oracle HCM and Service Now HR module. Work closely with HR and other depts and teams for business requirements. Tracked project tasks and deliverables using Microsoft Project management tool and delivered multiple reports like Gantt.

Facility Ticket Tracking Management System: Plan, design, requirements, validate, test cases, integrate, deploy the iOffice application for multiple locations (USA and UK). Integrated with Service Now using API interfaces.

Celgene, Inc. – Summit, NJ (http://www.celgene.com)

Sr Architect / Sr System Analyst March 2011 – Aug 2018

Development / Data Analytic - Design, Develop & customized pharma applications to custom needed to support the Pharma business team like Medical affair, Drug safety, Customer Service, Facility, HR and other department. Migrate data from legacy systems into middleware and upgrade applications. Databases and applications migrations, analysis data between applications, databases and file systems/servers.

Veeva/Salesforce Migration – The SalesLogix CRM was migrated to the Salesforce CRM includes database, forms, reports and interfaces. The migration initiative was handled with vendor, offshore and onsite teams for the Celgene Cellular Therapeutics CCT LifebankUSA / LifebankUSA.com.

Website Deployment– Spearheaded LifebankUSA website and integration projects that required website hosting with an outside vendor, monitoring project control for business team, oversight of integration and implementation of SalesLogix, StemLab, Solomon, and website site deployment.

Technology – Unix, Pearl scripts, C++, Java, J2EE, PHP, Oracle, SQL, PL/SQL, Forms, Reports, Pro*C, SQL Loader, Oracle Database, Matrix, Blueprint, IRise, ServiceNow, ITSM reporting, IDMP, MODA, HP ALM, Concerto, DTP, Subversion, Reference Manager, AWS/Cloud, Veeva, Salesforce, SAS, JIRA, Jreview, Reference Manager, Review-please, InForm, Central Designer & Coding, Medidata RAVE, IRT, RBM, PACE, Pinnacle 21, QMS, EQMS, LIMS, CTMS/Clinical Product Study, SIEBEL, Facilities/Chemical Tracking System, CRM, ERP, LAB systems, Clinical DW/OBIEE, SharePoint, Publishing Systems, QMS Track-wise, CTD, eCTD, Parexel, Nees, Clinical and Safety Data ware systems, OBIEE, Bigdata & etc

Reporting Tools- BI tools Qlik, Tableau, Teradata, SAS BI, Oracle BI & Microstrategy.

Celgene Cellular Therapeutics CCT (LifebankUSA) – Cedar Knolls, NJ (http://www.LifebankUSA.com)

Sr Architect / Sr System Analyst, May 2006 – February 2011

Website Management – Developed, design, updates, and support of company website. Collaborated with multiple departments to upgrade site and integrate other applications to optimize efficiency.

IT Systems– Effectively led IT systems administration and support at the facility.

Compliance – Ensured compliance with all CCT standards, SOX, FDA, GXP, CSV, 21 CFR part 11, SDLC, SOP and other regulatory requirements.

Technology – Java, J2EE Cutting Edge Technology, Hibernate, Springs, Struts, Servlets, XML, PHP, VB, VB scripts, SalesLogix Solomon, StemLab, IDMP and LIMS. Oracle, SQL, PL/SQL, Forms, Reports, Pro*C, SQL Loader, Oracle Database, Oracle Designer, UNIX, LINUX & Pearl scripts, C++, SFTP & FTP

Celgene Inc. – Summit, NJ (http://www.celgene.com)

IT Consultant/ Sr Architect / Sr System Analyst, February 2005 – April 2006

IT Projects – Managed design and implementation of an order management system (COMS_OP), reports system (CRS), integration of finance business codes in the C4 system, plus software source control system, and Req-Pro systems.

Project Support– Provided technical support for all systems and applications and collaborated with multiple departments, the Sharp distribution vendor, and the Solomon customer care center. Track project tasks and multiple roles and responsible using MS project tool as a project deliverables.

Compliance – Ensured compliance with all CCT standards, SOX, FDA, GXP, CSV, 21 CFR part 11, SDLC, SOP and other regulatory requirements for the biopharmaceutical industries. Managed documentation and validation of documents.

Technology – Java, J2EE Cutting Edge Technology, XML, Oracle, SQL, PL/SQL, Forms, Reports, SQL Loader, Oracle Database, FTP & SFTP.

Senior Lead – B.F Goodrich Corporation, Everett, WA Dec 1999 – Feb 2005

Oracle (ERP) & Impresa (JIT): Worked on a multi-group team Developing customizing maintaining and Manage [Inventory, purchasing, Finance, LTS (Labor tracking system), customized Order entry, Deferred Assets, work order status, and multi-plant process] Oracle Applications 10.7, Impresa 7.0, Company Portal, Ikon documents scanning process and Auto time (Kaba). FAA regulation required in Aerospace industry and involved in documenting validation documents.

Worked on a multi-group team Developing customizing and maintaining Oracle Applications 10.7, Impresa 7.0, Company Portal, Ikon documents scanning process and Auto time (Kaba).

Extensively developed customized and maintained Oracle application 10.7 for ATS (Aviation Technical services) for multiple modules like Inventory, purchasing, Finance, LTS (Labor tracking system) and customized Order entry.

Involved in implementation, customization and maintenance of IMPRESA, an enterprise wide application for multi-location MRO (maintenance, repair, and overhaul) in many components divisions of Goodrich across the nation. Developed and maintained multiple customized module like Deferred Assets, work order status, Inventory, purchase, finance and multi-plant process.

Customer support, development and maintenance across ATS for Company Portal using Microsoft ASP .NET and maintain IKON documents process.

Involved in Auto-time web report development using Microsoft ASP .Net and building PL/SQL packages to retrieved the data from database using ref-cursor.

Developed PL/SQL packages extensively to migrate data from various legacy applications to Oracle and during migration of Impresa to Oracle Applications and also customized forms and reports.

Involved and established coding standards and guidelines.

Automated ATS Calibration tools pickup process.

Automated Alternate item master process.

Followed FAA regulation required in Aerospace industry and involved in documenting validation documents.

Performance Tuning

Extensively tuned the Impresa application and redesigned the queries in forms and reports to perform well without affecting the functionality and setting up or changing the report parameters for an effective performance.

Worked with other team members on tuning several applications especially on SQL tuning using trace, and TKPROF utilities.

Environment: Oracle 9i, 8i, 7.3.4, MS SQL Server 2000/7.0, HP-UX 10.20, Sun Solaris, DYNIX, Oracle Applications 10.7/11i, Impresa 7.0, Erwin, Developer 2000, PL/SQL

Senior Programmer Analyst – General Electric, Shreveport, LA Jan 1999 – Dec 1999

Conversion: Focus to Oracle Database

Convert Focus (Hierarchy Database) into Oracle (Relational Database) and Extract data from Focus files and Insert into Oracle Database. The Focus database has its own focus data files which Stores data in Hierarchy Structures, Which holds all the data for the Transformer’s designing and Manufacturing unit. The Segment file in Focus Database are converted into Oracle Tables Structure by created proper Tables, constraints, indexes and referential integrity constraints. The Focus segment files are first converted into a text files and text files are then imported into Oracle Base tables, most of the Focus segment files are with CR-type (cross reference), joins with single and multiple paths. Tracking out the relationship between the files in focus with single and multiple paths. They are changed into referential integrity using primary key and foreign key relationship. Knowledge of the concept of joins between different files

All the focus data files do exist in the record length of 4096 in the main frame .So they need to be made compatible by dumping data into text format and is done on the basis of the single segment (focus) using SQL*Loader. The Focus v.7.0 is in Mainframe VM v.2 (Virtual Machine).

Responsibilities:

Designing the relational database table structures

Analysis the Focus segment file structure

Scripts for building tables and error handling

Loading data using SQL*Loader

Environment: Oracle 7.3, HP-UX, PL/SQL, SQL*Loader

Payroll / HR System Jun 1998 – Dec1998

Cyborg System, Inc., IL

Software Engineer

Project: Cyborg System has developed a Payroll/HR System, which is known as Solution/Series v.3.0. It provides wholesome solution for any company regarding Payroll and HR Process. The Solution/Series is based on English Language programming (EL). EL is Cyborg's proprietary Language.

Responsibilities:

Involved in testing, debugging, installing Solution/Series software and maintaining quality process.

Involved in taking care of solution for the Year 2000 problem through Solution/Series v.3.0 and Conversion from Solution Series v2.5 to v3.0.

Developed reports for Payroll Schedule process and Human Resource Process.

Environment: Windows 95 and DOS on Pentium based PC’s using EL-Program and Solution Series S7 - 2.5/3.0.

JIT – IMPRESA Jan 1998 – Jun 1998

Dataworks Inc., MN

Software Engineer

Project: JIT (Just in time) software is an ERP package, which provides wholesome solution for Any Manufacturing Industry related unit. The JIT Enterprise System is a complete set of Oracle based client/server software application to manage a manufacturing/distribution, finance, supply chain management and engineering.

Responsibilities:

Involved in the design of HLD, LLD, of Structural Maintenance Module (SM).

Coding, debugging & testing of purchase order and RO (Repair and Overhaul) module.

Created reports for purchase orders printing process and RO Modules.

Environment: Solaris v.2.3, Windows 95 on SUN SPARC Workstation using Oracle v.7.x as back end and Developer 2000 as the client

ARAMCO Oil Refinery, Sep 1997 – Dec 1997

Oil Refinery Processing System

ARAMCO Oil Refinery

Software Engineer

Project: This project is to automate the refinery process of ARAMCO and other departments in it. The data is electronically fed from a Honey Well system and used as input for Material Planning and Utilization. Involved in the design and development of reports. The system fully covers reports for three major divisions of the refinery viz., Materials Planning Utilization (MPU), Oil Movements System (OMS) and Oil Processing System (OPS).

Reports have been developed for finding various activities that occur in the oil refinery like raw materials that are added to prepare Oil, Diesel, Petrol, etc. The reports generated fully cover the time scheduled for the flow of raw materials and to find volume of oil flow in shifts on periodic basis.

Responsibilities:

Design and developed custom build reports

Tuning queries

Prepared Unit Test Plans

Environment: SUN SPARC Workstation v.20 on Solaris v.2.3 and Windows NT using Oracle v.7.3 and Developer 2000.

Employee Maintenance System Jan 1996 – Sep 1997

Megasoft Consultants, Inc., India

Software Engineer

Project: The system fully covers various Modules like Employee details, Attendance Maintenance, Library details, Employee Pay System. It helps to keep track of all details of the above modules. The development was done offshore in India.

Responsibilities:

Involved in analysis, design, testing of the above modules

Environment: Oracle v.7.3 as back-end with Designer-2000 as front-end.

Skype id: adtpba@r.postjobfree.com

Work Status: United States Permanent Resident (Green card holder)

Bachelors in Computer Science Engineering – University of Madras, India

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