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Click here or scroll down to respond to this candidateCandidate's Name
http://LINKEDIN LINK AVAILABLEEMAIL AVAILABLE PHONE NUMBER AVAILABLE Work Status: Green card holderCertificate: CSM (Certified Scrum Master), CSPO (Certified Scrum Product Owner),A-CSPO (Advance Certified Scrum Product Owner)Bachelors in Computer Science Engineering University of Madras, IndiaQUALIFICATIONS PROFILETechnical 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, CGMP, 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 AREASPharmaceutical 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 SKILLSSoftware & Languages: Python, PySpark, AI, ML, DL, Microsoft 365, Jira, QMS, eQMS,Tableau, 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, SAP, Concur, Siebel CRM, ChemCart, LIMS, SAS and PC SAS, iOffice, Insight, Big Data tools and software, FTP & SFTP.Databases: SYBASE, RDMS, ORACLE, SQL SERVER, MS Access, Mango, Apache Hive.CRM & ERP Tools: Veeva Salesforce, Saleslogix, Sibel CRM, Oracle, Impresa, Just In Time-JITData 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 deskOperating Systems: Windows, UNIX, LINUX, SOLARISManagement Tools: MS Office 365, MS Project, MS Visio, PowerPointSoftware Delivery, Validation & Professional ExperienceApetan Consulting LLCContractor (Product Lead/Delivery/Operations) Jan 2023 Apr 2024SAS: Experienced supporting systems and technology solutions for the Biostatistics & Data Management domain. Product & Project lead with track record of delivery & maintenance of both products & projects in a fast paced environment.Strong technology project, stakeholder, budget management and collaboration skills. Comprehensive knowledge of Clinician database development including Medidata Rave and 3rd parties. Knowledge of the EDC and ability to discern pro/con analysis of the different Vendors and formulate a future state strategy.Experienced in managing relationship with Medidata and other EDC Vendors and roadmaps to align with goals and objectives. Knowledge of eSource systems and integrating eSource systems. Knowledge of emerging technologies such as Python, PySpark, AI, ML, DL, NLP & other software.Document the Service now and SAS applications business rule, support process, work flow management process, build process flow diagrams, End-to-end system interface process, vendor management process, build power point presentations. Derive and document the IT process rules that need to flow from the business end user IT ticket creation, ticket process, assign tickets to vendor, build resolutions, test, validate, document and deliver into production. Document management/document change control, quality management system (QMS) support, technical communications. Experience MS Office Suite, Sales Force, Compliance Quest, and Track Wise.Eisai Pharma, Inc.Contractor (Product Lead/Delivery/Operations) Jul 2020 Dec 2022Oncology: Project Plan, scope, design, resource scheduling, cost management, requirements, test cases, integrate, validate, deploy management and documentation management for multiple application. Worked with the Clinical Pharma Architecture, PMO office, ITIL frameworks, SDLC, GAMP5Study 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 ). Deep knowledge of GD business processes, systems, pharmaceutical processes, systems, Solid experience maintaining the SAS platform and associated systems. Strong knowledge & managed the AWS, RDBMS & infrastructure process.Experience in migrating SAS platform to newer versions, developing a comprehensive plan for the migration, managing the execution of the migration plan, identifying and mitigating risks so that businessTechnology: ECCE/SAP/Concur/ SAS M7/ R /Pace/ Jira/QMS/CTMS/Veeva Vault/AWS/Azure/GCP/Cloud storage/AI/IoT: 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. Proficiency skills are Quality analysis, Applications, infrastructure, data science, data integrity, continuous improvement process (Agile, Scrums, DevOps & waterfall), Quality testing, Advance knowledge in GxP Regulations, Validation deliverables like SOP, CR, Val Plan, Non-CAPA & building solid reports for senior management. Processing sales orders in the SAP and Concur travel expenses processing and reports.Veeva Vault: System and client configuration through establishing document types, fields, lifecycles as well as supporting automation through workflows and notification management. Supporting Clinical and Regulatory users managing regulatory binders, submissions, and electronic Trial Master Files (eTMFs). Evaluating, planning, and managing direct integrations with related systems including standard vault to vault connections between TRIs Clinical Operations eTMF vault and a RIM Submissions vault as well as external integrations with Medidata CTMS.HCL (http://www.merck.com)Contractor (Product Lead/Delivery/Operations) Jan 2020 Jun 2020Documentation Management System: Plan, design, requirements, validate, test cases, integrate, deploy the documentation management system for multiple application.Technology: Cloud storage, AWS, Azure, IoT, Data science, Analytics, AI, Automation. Methodologies: waterfall, Agile, Scrums, DevOps. Quality testing, Advance knowledge in GxP Regulations, Validation deliverables like SOP, CR, Val Plan, Non-CAPA & building solid reports for senior management.Intercept Pharma (http://www.interceptpharma.com)Contractor (Product Lead/Delivery/Operations) Oct 2018 Jun 2019HR & 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.Technology: Cloud storage, AWS, Azure, IoT, Data science, Analytics, AI, Automation. Methodologies: waterfall, Agile, Scrums, DevOps. Quality testing, Advance knowledge in GxP Regulations, Validation deliverables like SOP, CR, Val Plan, Non-CAPA & building solid reports for senior management.Celgene Pharma, Inc. Summit, NJ (http://www.celgene.com)FTE March 2011 Aug 2018Development / 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.Vault: System and client configuration through establishing document types, fields, lifecycles as well as supporting automation through workflows and notification management. Supporting Clinical and Regulatory users managing regulatory binders, submissions, and electronic Trial Master Files (eTMFs).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, SAP, Concur, 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 & etcReporting Tools- BI tools Qlik, Tableau, Teradata, SAS BI, Oracle BI & Microstrategy.Celgene Cellular Therapeutics CCT (LifebankUSA) Cedar Knolls, NJ (http://www.LifebankUSA.com)Contractor/FTE May 2006 February 2011Website 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 & FTPCelgene Inc. Summit, NJ (http://www.celgene.com)IT Consultant February 2005 April 2006IT 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 2005Oracle (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 TuningExtensively 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/SQLSenior Programmer Analyst General Electric, Shreveport, LA Jan 1999 Dec 1999Conversion: Focus to Oracle DatabaseConvert 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 Transformers 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 filesAll 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 structuresAnalysis the Focus segment file structureScripts for building tables and error handlingLoading data using SQL*LoaderEnvironment: Oracle 7.3, HP-UX, PL/SQL, SQL*LoaderPayroll / HR System Jun 1998 Dec1998Cyborg System, Inc., ILSoftware EngineerProject: 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 PCs using EL-Program and Solution Series S7 - 2.5/3.0.JIT IMPRESA Jan 1998 Jun 1998Dataworks Inc., MNSoftware EngineerProject: 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 clientARAMCO Oil Refinery, Sep 1997 Dec 1997Oil Refinery Processing SystemARAMCO Oil RefinerySoftware EngineerProject: 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 reportsTuning queriesPrepared Unit Test PlansEnvironment: SUN SPARC Workstation v.20 on Solaris v.2.3 and Windows NT using Oracle v.7.3 and Developer 2000. |
