Product Manager Resume
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Resume:
Objective: Product Manager or Manager in Life Science / Pharmaceutical domain.
Summary:
Eleven years of experience in commercial software product development.
Skills include
Eleven years of Biotech Domain experience in Software Development and Implementation
Excellent mentoring skills including several technical presentations and training for Engineering, Customers and management
Designing and developing large scale enterprise database GUI applications through all stages of software development.
Planning and organizing software development project releases, including resource assignment.
Interfacing with marketing / clients to gather product requirements.
Good documentation and presentation skills to translate requirements to specs.
Well versed in GCP / GMP systems change control procedures for Project Implementation in Controlled environments.
Delivering software releases to product testing on monthly basis.
Well-organized with excellent communication skills.
Big picture thinker with ability to focus on details and results delivery.
Professional Experience
Aptuit Informatics, Bangalore, India – Jun
Product Manager May –Jun
As a product manager was part of five members Product Architecture and Design team with the primary responsibility of gathering and translating product / customer requirements in to functional specifications.
Participated in cross-functional project team to present progress, results, and problems, and assist with resolution of overall project issues related to the product functionality.
Well versed in the change control procedures.
Responsible for project documentation and timely delivery of the functional specifications.
Work with customers to gather and validate the functionality to be implemented in the product before the development process.
Provide Knowledge Transfer sessions to the development, testing and client services team members on the new / updated product functionality and the related impacts.
Work with the development design during the design phase of the project to ensure the desired functionality can be implemented.
Continuously work with development and testing teams during the development and the testing phase to resolve functionality clarifications and issues.
Responsible to ensure the required functionality and changes have been implemented in the product prior to release.
Responsible for the documents at the time of release.
Labeling System . release (LS., an ancillary product of the Clinicopia Suite)
An Oracle Forms cum Java based Application used for designing, managing and printing clinical labels. The system included a graphical Label Designer to design labels with multi-language support, phrase translations and global electronic web approval system.
Participated in cross-functional project team to present progress, results, and problems, and assist with resolution of overall project issues related to the product functionality.
Participated in design meetings and provided functional clarifications during the implementation phase.
As product manager was responsible for the Functional Specification documents
Conducted Knowledge Transfer Sessions for development and testing teams.
Continuously worked with the development and testing teams during the development and testing phase of the project.
Clinicopia . release
An Oracle Forms cum Java based Application designed to address the needs associated with the Clinical Supply Chain. Clinicopia comprises of functions related to the clinical supply management processes like planning and managing the manufacturing of dosage forms to distribution and assignment of packaged kits, tracks and maintains the clinical material inventory. As a core member of the team contributed the functional specification documents required for the release.
Responsible for the design and development functional specification documents for core modules Create Orderable Kits, Define Label Parameters, Label Designer and Printing functionality, Container Label Designer and printing functionality and User Events and Login enhancement functionality.
Incorporated changes from the Labeling . release into the . release.
Conducted Knowledge Transfer Sessions for development and testing teams.
Participated in design meetings and provided functional clarifications during the implementation phase.
Continuously worked with the development and testing teams during the development and testing phase of the project.
PDL BioPharma, Fremont, California – April
Sr. Programmer Analyst / Project Lead Feb – Apr
As a project lead supervised team of technical developers across four project deliverables.
Participated in cross-functional project leadership team to present progress, results, and problems, and assist with resolution of overall project issues.
Well versed in the change control procedures.
Responsible for project documentation and timely delivery of the functionality.
Responsible for resource management.
Work with consultants both remote and onsite.
Worked with validation during the IQ, OQ and PQ execution phases.
Adverse Event System Phase I /II (Oracle AES System)
An Oracle Forms application for tracking and reporting system for clinical and post-marketing Adverse Events, Serious Adverse Events, and Product Complaints. The application is launched from Oracle Portal. Led a team of developers.
Worked with the vendor during the implementation phase and responsible for project documentation.
Performed User Training and Application training to the team (System owners, validation team).
Worked with the System Owners to understand the requirements and help enhance the system to its maximum productivity.
Prototyped Custom reports using Oracle Portal functionality.
Implemented the MedDRA and the WHODrug Upgrade
EB Submissions for EMEA and FDA
A comprehensive web-based application .The system was deployed on three environments. Led a team of developers.
As project lead participated in the Vendor Selection process.
Worked with the vendor during the evaluation, implementation and testing process.
Responsible for Project documentation and customization of the Adverse Events System to support EB functionality.
Automated the submissions process for electronically submitting reports to the Health Authorities.
Worked with validation during the IQ, OQ, PQ execution phases.
Clinical Trial Management System Phase II (Siebel CTMS)
A comprehensive web-based business application designed to help pharmaceutical companies manage investigator relationships, clinical research associate (CRA) activities, and overall clinical trial status. Led a team for developers ( remote and one onsite).
As a Technical Owner responsible for the technical design, development, implementation and reliability of the system.
Participated in the validation execution cycle (IQ, OQ, PQ).
Responsible for the migration from Dev – Test – Production.
Portal Project Phase I
An Executive dashboard that will enable the company to execute proactively, providing a top-down, quantitative reflection of the business strategy and establishing a strategic reporting system based on uniform organization-wide metrics. Contributed as a core member of the executive dashboard team in identifying timelines, feasibility, short term / long term solutions. Led a team of developers including Sap / Oracle Consultants ( remote and onsite).
Conducted an evaluation and selection of software tools for automating a corporate enterprise portal, dashboard, and data warehouse.
Worked with management team, senior managers and consultants to gather the requirements and Key Performance Indicators.
Led the implementation of the manual executive dashboard in support of the executive team.
Developed proof of concept using Oracle / SAP portals and held demonstrations with potential Dashboard Vendors.
Applied Biosystems, San Jose, California –
GUI Lead – Sep
Supervised team of seven technical developers and contributed as core team member to the analysis, design and development of the LS*LIMS software product for large-scale laboratory automation for academic research and pharmaceutical companies requiring CFR quality system compliance. Contributed as a core member for the timely delivery of functionality to Product Test.
(Technology: Distributed, n-tier services-based architecture, JEE, JBoss, JDK .., Java Swing, XML)
Participated in cross-functional project leadership team to present progress, results, and problems, and assist with resolution of overall project issues.
Worked with Marketing to understand customer feedback on latest releases and decide how to modify functionality as well as look and feel to meet expectations.
Supported Product Test teams during market validation and development cycle to convey functionality and troubleshoot problems.
Led prototype development efforts with small development team that developed Java Swing based GUI prototypes for Market Validation and project approval.
Led GUI team and contributed to design and development of the first version of the product, which shipped to customer beta sites for evaluation.
Worked with UI consultants to refine and incorporate changes that improved the overall look and feel and usability of the product.
Contributed to the design of the database schema (Oracle i) for the entire application to assure flexibility and room for expansion.
Designed and developed Java Swing core module, ProcessSetup, used by lab managers to set up laboratory processes, assigning resources, and start the workflow, generating tasks.
Designed and developed pluggable activities associated UIs for use by lab analysts to perform tasks.
Achieved design goal of product extensibility for AB Professional Services and customers to customize software for their specific requirements.
Significantly contributed to the design of the Process Framework, Process Template Editor, and Lab Console infrastructure resulting in three provisional patents.
Developed and delivered training for the AB Professional Services Team including a GUI Demo.
Senior Software Engineer –
As senior team member contributed to the design and development of optional product SQL*GT . to perform container centric operations for biological laboratories.
Contributed to the design and development of new modules (Sample Map Editor, Attachments Editor) for the first version of the software in Java that shipped to customers.
Developed numerous enhancements for the existing version of the software using Oracle Forms, PLSQL stored procedures.
Contributed to the design of the Audit-Esig configuration tool (Java Swing) used for configuring auditing, versioning and electronic signature settings in the software.
Supported Product Test teams during development cycle to convey functionality and troubleshoot problems.
Software Engineer
As software team member, developed new modules and provided sustaining support for legacy laboratory automation system using Oracle Forms, database stored procedures.
Developed and delivered major enhancements and functionality which resulted in the release of product SQL*LIMS . (next generation LIMS) to customer sites.
Contributed to the design and development of user interface for SQL*LIMS . which improved the usability and the look and feel of the overall product.
Converted character mode application to client/server.
Read and understood entire baseline code and functionality, fixed bugs.
Earned a reputation for writing high quality software with fewest bugs reported.
Developed and delivered new modules for the optional product SQL*Protocol to perform tracking of preclinical studies integrated into SQL*LIMS.
Implemented Electronic Signature functionality to achieve CFR compliance in SQL*LIMS product releases (SQL*LIMS ., SQL*LIMS ..MR, SQL*LIMS .).
Technical Skills:
Languages / Protocols / Methodologies:
Java, XML, JEE (Java Swing, EJB, JDBC), OOAD,UML
Database / Application Server:
JBoss, SQL, PL/SQL, Oracle i / i, Java Stored Procedures, JDBC
Operating Systems:
Windows / XP, NT, Sun Solaris, HP-UX
Tools / Applications:
Oracle Developer i, JDeveloper, IDEA, PVCS, CVS, MS Office, XPlanner, Twiki, Oracle Adverse Event System, Siebel Clinical Trial Management System, Cyclone eSubmissions express, Oracle i Portal
Education:
B.S. Statistics, University of Madras, India.
M.S. Statistics, University of Madras, India.
Diploma in Computer Science ( years), APTECH, India.
Recent technical training:
ICMG Architecture Training
Speak Up Training
Object-oriented Analysis and Design (Valtech)
Beginning and Advanced Java GUI development using Swing (University of California extension)
Oracle Adverse Events System Application
Work Permit:
US Citizen and Work Permit (PIO Card) for India
References:
Will be provided
