PROFESSIONAL SUMMARY:

Highly skilled having various IT responsibilities consisting of application development, acquisition, planning, implementation, analysis, and integration involving many environments requiring interoperability with middleware in the medical device, Pharma, R&D, and manufacturing industries. Recognized team player, experienced manager, proven track record involved in managing many projects.

STRENGTHS INCLUDE:

• Lab Instruments & Applications
• Supply Chain & Logistics
• Healthcare - POS - R&D
• Manufacturing
• Regulatory - GXP, 404, & HIPPA
• Financial applications

TECHNICAL SKILLS:

HARDWARE: i5/AS400, PC's, HP9000, Ethernet, and PC platforms, bar code terminals and printers, various switches, hubs, printers, scanners, optical drives, lab instruments.

SOFTWARE/APPLICATION EXPERIENCE:

Languages: RPGILE, IV, II; Cobol, CICS Cobol, Basic

SQL: M/S SQL Server, Oracle PL/SQL, i5/AS400 SQL

DB’s: DB2, MS SQL, Oracle, Access, Progress, dBase, rbase Integration to and from middleware webMethods of various .xml & HTTP post the likes of Oracle EBS 11i, Agile PLM, Vertex, iTrax/TMS, BPCS, Mapics, IPM, Blueprint

Other: BRIO Hyperion Query, Client Access, NT, TCP/IP, Netware, Windows & DOS Office Pro, including Project Manager, Visual Studio, Linux, Windows, SharePoint, Lotus Notes Epic, QS1, RX30, Telemanager, RMS POS, Surescripts, Vecna, Pickpoint, Endicia, Sentry, Pyxis, Talyst, RxSafe, Innovation, ScriptPro, HL7, Vestigo

REGULATORY EXPERIENCE: ISO, ISO13485, QSO, GMP,GLP,GXP, FDA/820 & 21 CFR Part 11, COBIT, 404, HIPPA, Confidential

PROFESSIONAL EXPERIENCE:

Service Engineer

Confidential, Cambridge, MA

Responsibilities:

• Facilitating the onboarding, changing, moving, and retiring of scientific instrumentation and applications within in R & D, Technical Development labs

CLIO Service Engineer, Cambridge, MA

Confidential, Cambridge, MA

Responsibilities:

• Facilitating the onboarding, changing, moving, and retiring of scientific instrumentation and applications within in R & D, TD, and Manufacturing Sciences laboratories.
• Lead in coordinating the onboarding of scientific instrumentation in the creation of the Oligonucleotide Analytical and Development labs $6 million in 8 weeks.

PE Primary Contact and Project Specialist

Confidential, Boston, MA

Responsibilities:

• Research and fact gathering at Confidential Institute Confidential in their R&D labs dealing with Laboratory Data Management.
• Worked with a cross section of oncology research labs involved in biology, chemistry, genomics, cellular, pediatrics, performing in vitro and in vivo experimentation to better understand their LDM needs.

Scientific Application Support Analyst

Confidential, Cambridge, MA

Responsibilities:

• Supporting ACD Labs version 14 and Pipeline Pilot version 9.5 upgrades

One Source Lab IT Engineer / Analyst

Confidential, Cambridge, MA

Responsibilities:

• Confidential Genzyme Windows 7 Global Procurement Team member supporting R&D laboratory instruments involved in the Windows XP to Windows 7 migration project.
• Performed research and built profiles and estimates to upgrade 648 lab instruments.

Senior Business Analyst/Application Analyst

Confidential, Boston, MA

Responsibilities:

• Liaison between IT Services and Pharmacy group supporting both inpatient and outpatient systems.
• Also supporting 340B, Investigational Drug Services, and Specialty Drugs systems.
• 5th largest outpatient pharmacy in the USA: POS, Robotics, $50 million retail sales per year.
• Inpatient pharmacy has 125 employees: Epic, Pyxis, Talyst, Doseedge
• De facto team lead: responsible for ITS functional and infrastructurel support services of all pharmacy systems and vendor support.

Business Analyst

Confidential, Mansfield, MA

Responsibilities:

• Developed requirements, use cases, processes, SOP’s, training, and systems to comply with the Confidential Sunshine Act.
• Worked with SDLC team using agile methods to implement necessary changes.

Business Analyst

Confidential

Responsibilities:

• Member of the Enterprise Management Office (EPMO): involved in the Health Care Reform project dealing with Enrollment and Eligibility involving BRD & EDI 834 and 820’s.
• Used Blueprint to develop documents and use cases. Led JAD sessions.

Confidential, Cambridge, MA

SR R&D IT Business Analyst

Responsibilities:

• For chemical and biologics, integrated into the ELN/ electronic lab notebook project having many EHS/Environmental Health and Safety implications.
• Designed and developed ELN barcode labels using Bartender & Commander.
• Built prototype/sample Sharepoint sites for R&D labs.

Confidential, Boston, MA

Controls/IT Business Analyst

Responsibilities:

• Provided tools and performed analysis in support of the Accelerated Bridge Program for the client Mass Department of Transportation.

Confidential, Braintree, MA

Global Business Process Manager & IT Project Manager

Responsibilities:

• Set up distribution system for the new manufacturing facility in Draper Utah.
• Supported Oracle IPM document imaging system.
• Co-converted Phase 2 AP & Purchase Order data into Oracle EBS ERP.
• Responsible for Phase 1 OTC/Order to Cash portion of Oracle EBS ERP implementation and its interfacing into cTrax shipping manifest system as well as providing support for Vertex sales tax module.
• Co-led the team responsible to find and implement a ship manifest application called cTrax that allows freight shipping and carrier connectivity with the effect of a 20% reduction in transportation rates plus 15% increased warehouse productivity.
• Liaison to the tax department for EIE/DMD credits usually $2 mil+ per annum, Sales Tax support, designed an international Vat tax reporting system, in addition to working with the IRS to claim and receive a $6.5 million tax credit. Assisted with FAS fixed assets. Personally doing all the above tax programming.
• Participated on the Agile PLM implementation team, authored the first Audit workflows, plus orchestrated/designed the PS&I Complaint module’s ability to push data streams into queues to apply data to a QA data warehouse and a MS Server to generate analytics and multiple language customer response letters.
• Designed and wrote a worldwide inventory system reducing inventory in the supply chain by 18%.
• Team leader for company of FDA 21CFR Part 11 electronic record and electronic signature compliance Lead the IT team in an M&A: integrating products and processes into corporate MRP BPCS.
• Planned a worldwide ocean container tracking system called OTIS.
• Designed and wrote CQRS Corporate Quality Reporting System that warehoused and presented the companies worldwide product quality details and metrics e.g., DPM/Defects Per Million.

Confidential, South Boston, MA

Senior PA/Systems Analyst

Responsibilities:

• Confidential coordinator of a 28 member Confidential team responsible for testing, identifying, and fixing all year 2000 date problems and dealing with obsolete systems throughout the company. Project involved 1400 programs that were corrected and tested many systems replaced.
• Designed and installed COLD storage system to archive reports on PC laser and optical disk but retrievable via any dumb terminal on AS400 or PC.
• Member of team to interface HP Unix CAD to AS400 product structures to better implement new products and engineering changes and file converting.
• Led planning of 10 BaseT ethernet wiring system to connect all Confidential platforms.
• Designed, wrote, and implemented a system to measure Made vs. Planned.
• Worked on team to calculate and reduce cycle times, improve capacity planning, and measure work center performance using CA/Sim400.

Confidential, Sterling, MA

Manager, MIS

Responsibilities:

• Successfully merged IT systems of two divisions of the corporation by integrating manufacturing of both division’s yet isolating the accounting. Converted Unix/QAD to BPCS for a molding company in Sterling Mass: Carbolon. Formed and implemented the plan; supervising personnel of both divisions.
• Improved financial integration of BPCS and business processes to enable the preliminary closing of the fiscal year in one working day.
• Led the project that restructured the Marketing/Manufacturing relationship allowing a Marketing created forecast to drive MPS/MRP, Manufacturing to build to the forecast, and Customer Service the ability to promise against future receipts in placing orders without having to check with Production Control (ATP).
• Coordinated the implementation of Standard Costing using BPCS including the automatic consolidation of inventory transactions and Purchase Price variances. In combination with ATP obtaining an inventory reduction of 70%.
• Was the earliest adapter of shop floor and time & attendance PC driven Bar Code data collection system.
• Led conversions from MRP Mapics, to BPCS36, to BPCS AS400; instituted Novell network that supported High Voltage corporate financial staff, ran a payroll service bureau