Project Leader Experience: • Led validation of new WFI capability using Good Automation Manufacturing Practices (GAMP5) in operation (change control) lifecycle stage for Large Scale Cell Culture (LSCC) Facility including Installation Qualification (IQ), Operational Qualification (OQ) of associated DeltaV phases. Responsibilities also included management and guidance of contractor resource to execute portions of change control testing. • Led validation activities for project qualification (GAMP5) of DeltaV recipes/phases and OQ of new systems on manufacturing floor within new Single Use Facility (SUF) Phase 2 facility. • Led Validation planning, scheduling and execution activities in SUF adhering to GAMP5 principles from 2018-2020 including project development, execution and management for DeltaV systems within Phase 1 and 2 and Cell Bank areas. Manufacturing Support Experience:• Leads testing of required configuration changes to Process Automation System (DeltaV) and process recipes in the site Manufacturing Execution Systems (Syncade) using promulgated BMS procedures based on GAMP5 concepts. • Leads validation work for manufacturing systems within System Development Lifecycle (SDLC) phases (project and operation) including change controls, capital projects, shutdown/changeover activity and ongoing revalidation programs in DeltaV and Syncade. • Develops appropriate validation methodologies in collaboration with Manufacturing Operations (MFG Ops), Digital Plant (DP), Manufacturing Engineering (MFG ENG), Manufacturing Science and Technology (MS&T), and Quality Assurance (QA) for novel projects. Review Risk Assessment profile for proposed changes representing Validation with stakeholders QA, DP, MFG ENG, MS&T and MFG Ops. • Provides validation subject matter expertise to multi-function teams, advises operations on validation matters and defends their work before regulatory agencies.

Bristol-Myers Squibb, Co., Devens, MA Senior/Compliance Specialist – Manufacturing Compliance• Lead Investigator responsible for conducting Quality Exception (QE) investigations generated due to manufacturing operations exceptions, Process Digital Plant System/Compliance Suite anomalies, and manufacturing maintenance exceptions. • Responsible for leading, coordinating and communicating with the QE team and cross functional groups including Validation, QA, DP, MFG ENG, MS&T and MFG Ops to develop root cause using root cause analysis tools (fishbone, 5-why, is/is not), process mapping and Kaizen activities instituting Corrective Action/Preventative Action (CAPA) as needed. • Required to utilize a variety of validated systems to evaluate data for system performance including TrackWise, PI Process Book, Maximo, Syncade and DeltaV. Draft and review reports based on data collected to proactively identify areas for appropriate change control. Submit completed reports on time identifying QE Root Cause, proposed CAPAs and delegation of CAPA owners. • Provide summary of investigations to Senior Management Team (SMT) for approval and defend investigation Root Cause and CAPAs for Pre-Approval Inspection (PAI) and regulatory agencies (FDA).

Prepare variety of stock and process buffers and media (Aba—CD-CHO-Medium, Aba-Feed, rHu Insulin, 2M Tris) according to approved SOP’s using automated systems Syncade and DeltaV at Devens Large Scale Cell Culture (LSCC) facility. Additional duties include direct charge of raw materials to preparation vessels, use of Triblender© and Powder Transfer System (including crane operation), weighing of raw materials for use in media and buffer recipes and integrity testing of filters.Responsible for coordinating and communicating with the manufacturing team and Validation for the preparation, CIP, SIP, and maintenance of media preparation, buffer preparation and buffer hold process equipment using cGMP methodologies and applicable SOPsAssisted in associated production projects including preparation of Critical Process Parameter and Process Parameter tracking charts for stock/process buffers and media batches prepared at LSCC facility, recipe electronic change control (ECC) and SAP materials migration/preparation of material specification documentation.Responsible for troubleshooting of production systems during site technical run batches, process validation batches and commercial production lots.

Senior Project Scientist for a variety of construction oversight and hazardous waste abatement projects. Duties included preparation of project bid specification, preparation of request for proposal (RFP), review and selection of subcontractors, oversight of site safety and environmental consultant for overall site management of hazardous materials. Additional responsibilities included preparation of a variety regulatory filing documentation reports for submission to client, Massachusetts Department of Environmental Protection (MassDEP) and New Hampshire Department of Environmental Services NHDES). Reports included (but not limited to) Phase I Initial Site Assessments, Phase II Comprehensive Site Assessments, Immediate Response Action (IRA) reports, and Response Action Outcome (RAO) reports.

Assistant Project Manager for a variety of construction oversight and hazardous waste abatement projects. Duties included preparation of project bid specification, preparation of request for proposal (RFP), review and selection of subcontractors, oversight of site safety and environmental consultant for overall site management of hazardous materials. Additional responsibilities included preparation of a variety regulatory filing documentation reports for submission to client, United States Environmental Protection Agency (EPA) and Massachusetts Department of Environmental Protection (MassDEP). Reports included (but not limited to) Phase I Initial Site Assessments, Phase II Comprehensive Site Assessments, Immediate Response Action (IRA) reports, Quality Assurance Project Plans (QAPP) and Response Action Outcome (RAO) reports.Additional duties included preparation of multiple Phase I reports for various electric power plants and related assets as part of large scale capital investment project. Preparation of project matrix risk analysis was also completed as part of capital funding presentation.