- Nineteen (19) years in Life Sciences MES including experience with supplier and life sciences manufacturers
- Roles include senior consultant, senior software engineer, senior project manager, department manager
- Proven leader in design, delivery, and implementation of software, managing globally dispersed teams
- Successfully delivered MES solutions to pharmaceutical and biotechnology companies including Thermo Fisher Scientific, Sandoz, McNeil, Merck, Amgen, and Genzyme
- Experienced at defining and configuring interfaces between ERP, MES, and DCS
- Skilled in all phases of project life cycle, from user requirements gathering, functional and conceptual design through implementation and validation.
Professional Experience
2020 to Present
Director of Operations, North Carolina
Manage Operations of North Carolina office including MES and Controls experts while providing Consulting expertise to our customers
Project: XXXXXXXXX, (MES Project Manager)
- Project Manager for implementation of $6 million PharmaSuite MES rollout including:
- Electronic Workflows, replacing paper logbooks throughout the facility
- Electronic Batch Records in the Solution Prep production area (Media and Buffers)
- Responsible for development of all project documentation including Validation Plan, Design Documents, Validation Test Protocols
Led sub-teams, including Automation, SAP, Validation and Operational Readiness to ensure all areas of project implementation were covered and the project was successful
Project: XXXXXXXXXXXX (Process Consultant)
- Developed URS for upcoming MES project through process evaluations across all production areas
- URS was used as the basis for Vendor Selection in next project phase
2015 to 2020
Senior MES Consultant
Project: XXXXXXX MES
- Implemented MES recipe design changes for PAS-X V2 to PAS-X V3 Transition Project, and PAS-X V2.3.3 Upgrade Project
- Managed SDLC documentation associated with MBR recipe updates; ensure complete cross-references between all SDLC documents (test protocols, requirements specification, and traceability matrix)
- Tested Process MBRs including tightly integrated DCS communication elements to support shop floor operations
- Managed validation test execution efforts within MES team as primary point of contact to key business stakeholders
- Provided on-call support to operations, assisting shop floor personnel with issues in PAS-X V2 and V3
XXXXXXXX 2014 to 2015
Project Manager - Manufacturing Execution System (MES) Implementation
- Successfully led cross-functional team in implementation of $1.5 million MES rollout in bulk production and packaging lines as part of Agency commitment
- Managed software optimization process including requirements gathering with MES Steering Committee, vendor negotiations, software implementation, validation
- Implemented MES recipe design changes for PAS-X V2 to PAS-X V3 Transition Project, and PAS-X Built and reviewed MES recipes for site portfolio of bulk manufacturing products to ensure completeness and accuracy in transition for paper to electronic batch record execution
- Developed MBR validation strategy to streamline testing ensuring designs meet business requirements
- Managed rollout training process across all functional areas
- Led informational and organizational meetings at operational and site leadership levels to ensure awareness of project progress, challenges and needs for collaboration across functional groups
XXXXXXXXXXX
Head of Department – North American Customer and Project Management 2012 to2014
Sr. Project Manager 2008 to 2012
Project Manager 2005 to 2008
Sr. Software Engineer 2003 to 2005
- Successfully delivered customized MES systems throughout North America including Weigh & Dispense and EBR solutions to pharmaceutical and biotechnology companies
- Negotiated customer contracts for consulting and training services, and software enhancements
- Led in-depth requirements-gathering and design meetings with key project participants to identify user requirements and software gaps; identified with customers which gaps may be closed by adopting best-practice business processes
- Composed functional and design specifications describing system behavior, required enhancements and configurations including interfaces to ERP, SCADA and other third-party systems
- Managed 15 direct reports and project team members across 4 U.S. locations, Europe and Asia providing leadership and mentoring, focused on emphasizing individual strengths and developing areas of weakness
- Held ongoing discussions with software testing and quality management teams to ensure developed software met all customer requirements as well as internally established company standards
- Supported Sales and Marketing Team with presentation preparation and delivery
- Implemented program to define clear, measurable goals for employees at all organizational levels. Error rate has decreased 50% with the implementation of this program
- Built software solutions utilizing a variety of programming languages including PL/SQL, C++, and Visual Basic
2000 to 2003
Programmer/Analyst
- Software developer for leading provider of pharmaceutical product data
- Utilized diverse set of coding languages to implement business requirements
- Developed high-profile applications to provide on-demand clinical drug data to healthcare professionals
1999
Team Lead
- Managed 11 direct reports for provider of marketing support to pharmaceutical customers
- Managed vendor relationships to ensure timely delivery and clear tracking of pharmaceutical samples
- Designed data transfer methods and agreed-upon file structures for internal and client IT departments; composed functional specifications defining data exchange process
Education
- Master of Business Administration• Business Management • Hofstra University• Hempstead, NY
- Bachelor of Science• University of Illinois• Urbana-Champaign, IL
- Diploma in Client Server Programming• Chubb Computer Services, Top Gun School • Parsippany, NJ
