Experience

Astrix

• United States
• IT Services and IT Consulting
• 300 - 400 Employee

• Business Analyst

  • Jul 2017 - Present

  LabWare LIMS Implementation Project LabWare LIMS Implementation Project



free agent

• Scientific Applications Support – LIMS Manager – Business Analyst

  • 2009 - Present

  currently seeking opportunities currently seeking opportunities



inVentiv Health Clinical

• United States
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Senior Specialist, IT Applications

  • Feb 2013 - Jun 2017

  • Responsible for application administration: maintaining, implementing, and supporting the application software used by early stage lab in Princeton and in Quebec. • Write, review, and/or complete SDLC documentation as needed, write and/or execute tests, and write and review specifications, documentation, training/operating manuals, and SOPs related to the division's software. • Contact external consultants and suppliers concerning the development, validation, support, and maintenance of the division's applications. • Administrate the division's applications according to the evolution of operational needs. • Oversee the rollout of the division's applications and help train users. • Help IT teams and DSS to understand and support division's applications as needed. • Analyze, develop, and/or implement appropriate desktop solutions for users, in order to respond to identified needs. • Assist in reviewing/harmonizing the division's work processes and those of other divisions when applicable.



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Lead Business Analyst (contract)

  • Mar 2012 - Feb 2013

  Business Planning and Operations Group OpenLAB Adoption Project • Collect and document lab requirements for OpenLAB adoption. Business Planning and Operations Group OpenLAB Adoption Project • Collect and document lab requirements for OpenLAB adoption.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Business Analyst (contract)

  • Dec 2010 - Jan 2012

  Medicines Development Group, Applications and Data Integration Data Migration Project • Developed tools and processes to extract and copy clinical data files from various systems for integration processing using Visual Basic for Applications (VBA), Documentum Query Language (DQL), and Robocopy. • Evaluated clinical study data files and study designs from over 500 protocols for integration into new data systems. • Created weekly project manager’s reports on progress against milestones, status, resource requirements, issues, risks, and dependencies. Applications and Laptop Migration Projects • Documented and prioritized business requirements across affected Clinical Pharmacology and Statistics business areas. • Developed complete and accurate business models including process, data, and organization as required. • Worked with business owners from affected business areas to understand current processes and to document and prioritize requirements. • Worked with delivery workstreams to communicate business objectives and requirements, make decisions on delivery options and produce delivery costs and timescales. • Worked with business owners and delivery workstreams to develop optimal solutions. • Worked with project managers to plan analysis work and highlight risks and issues. • Worked with the business owners to define acceptance criteria. • Developed user acceptance test plans and business models incorporating process and data models. • Wrote test scripts for laptop migration. • Created and executed project work plans and revised as appropriate.



Tech Committee - Professional Service Group of Central New Jersey at Somerville

• Volunteer

  • 2009 - 2010



LabVantage Solutions, Inc

• United States
• Software Development
• 700 & Above Employee

• Business Analyst

  • Jan 2007 - Jul 2009

  Interfaced with subject matter experts (SMEs) to understand user business processes and gather functional requirements, write functional specifications, and monitor development and configuration of customized Laboratory Information Management System (LIMS) systems. • Conducted and facilitated customer site audits with lab scientists, SMEs, and other project stakeholders as needed for information gathering. • Worked with appropriate SMEs to understand and simplify business processes to increase efficiency and ease transition to new scientific applications. • Outlined design models for Sapphire databases. Collaborated with Solutions Engineers to implement and develop customer solutions. • Prepared functional and technical documentation, testing and acceptance plans.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• LIMS Manager

  • Feb 2002 - Jan 2007

  LIMS Manager – Systems Support Group, Bioanalytical Research (BA), Drug Safety & Metabolism division (DSM) WATSON LIMS Manager (DBA) for BA, Pearl River site Provided support for all system functions to scientific and other users in BA, Pearl River, and other sites as needed. Trained new users and performed update training as needed. • Gathered user requirements and created specifications for new system functionalities during vendor development, then worked with vendor developers to evaluate solutions. Supported application development, validation, and implementation. • Liaison between lab/scientific staff and IS/IT groups. • Managed various department databases, department IT inventory and purchasing. • Part 11 Project Coordinator for entire DSM division. Clinical Data Manager for BA department interactions with Clinical Department. • Evaluated Clinical Department procedures, programmed and implemented application and automated process to transfer clinical trial data to CROs, and internal and external labs, eliminating manual processing and errors, and reducing processing time over 95%. • Created automated processes to streamline transferring study data back to Oracle Clinical from various internal and external lab systems.



Wyeth-Lederle Vaccines

• QA-IS Specialist

  • Dec 1999 - Feb 2002

  Project Manager for migrating WLV Pearl River site from paper-based SOP system to GxPharma (Documentum) EDMS • Interviewed, hired, and managed staff of seven to assist in project completion. • Created project plan and planned budget. Managed the QCIS LIMS system to ensure proper collection, calculation, and analysis of Quality Control test data used in support of government release of product in a GMP environment. • Provided support for all system functions to users in Pearl River WLV. • Interfaced with QC laboratories and QA personnel to generate QCIS test procedures and set test specification limits.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Scientist

  • Feb 1992 - Dec 1999

  Performed various procedures for the determination of drug distribution, metabolite identification, and drug levels, in a GLP environment for Pre-Clinical and Clinical studies. • Assisted in experimental design and set up, data reduction, and analysis. • Created various applications to automate report writing. Performed various procedures for the determination of drug distribution, metabolite identification, and drug levels, in a GLP environment for Pre-Clinical and Clinical studies. • Assisted in experimental design and set up, data reduction, and analysis. • Created various applications to automate report writing.



Johnson & Johnson

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Research Assistant

  • Mar 1991 - Feb 1992

  Research Assistant – Drug Metabolism Department Performed drug level analyses in various Clinical Studies • Validation of Radioimmunoassays of human biological fluids Research Assistant – Drug Metabolism Department Performed drug level analyses in various Clinical Studies • Validation of Radioimmunoassays of human biological fluids