Gloria Gadea-Lopez, Ph.D. Email & Phone Number

Boston, Ma, Us

Supporting the advancement of digital solutions for CMC and Knowledge Management. Enabling efficient technology transfers, facilitating registrations, risk identification, and data availability across all stages of the product lifecycle

Greater Boston

Greater Boston Area

Joined Accenture with the acquisition of Enterprise System Partners in 2019. Supporting the digital transformation of biopharmaceutical companies with technologies that suit their operations and business objectives. Leader of multiple studies for strategy definition and roadmaps to modernize operations across the pipeline. Specific areas include: Process Development, CMC, Manufacturing, Manufacturing Sciences and Technology, Tech Transfers, and alignment of business process across the Supply Chain.Specialty in integrated data and analytics systems and practices to advance digital maturity and uncover new insights. Expertise developing accelerators and tools for digital assessments and identifying the appropriate technology for each business situation, process maturity and step in the process/product lifecycle.

Lexington, Massachusetts

Responsible for: 1. management of a high-performance team owners of Process Data Analytics with Statistica Enterprise and deployment of INFOR Advanced Scheduling; 2. comprehensive program to manage Single Use Technology; 3. Portfolio Management for internal manufacturing (2016-2017); 4. foundational work for the future deployment of MES, ISA88 process maps, interface strategy for process data analytics and related compliance.In alignment of strategy of Technical Operations, developed transformation maps and phased approach for all areas of direct responsibility as well as talent development.Ensured that data analytics projects were executed and delivered the user requirements for Manufacturing Science and Technology, Manufacturing, Process Development, Floor Support teams, Materials Management, and Quality. Sponsored OSI PI, finite scheduling, and SIMCA (multi-variate analysis) projects. Led the preparation of business cases, budget and resource planning for new initiatives. Member of steering committees of operations systems and responsible for the upkeep of these systems across their lifecycle.Represented Shire at relevant industry conferences and collaborate with academic institutions to support educational efforts. In addition to the team of permanent employees, mentored multiple summer interns and talent from rotational Shire programs.

Lexington, Ma

In collaboration with IT, Engineering and QA, develop vision and strategy for electronic applications for Internal Manufacturing. Led Front end studies with external consultants covering areas of business continuity, GMP compliance and validation, team integration, implementation, change management and use of systems for biotechnology operations on the production floor.Identified vendors and consultants to support the development of a global data-management strategy for process analytics, alignment of finite scheduling with ERP system and, foundational studies for the future implementation of MES for facility with Single Use Systems.

Lexington, Ma

Project leader of the successful implementation of Statistica Enterprise, a comprehensive GMP compliant data aggregation and analysis tool for the Rare Disease business unit. System deployed at two manufacturing sites for three commercial products (cell culture and downstream purification). Per ISA S95 and ISA S88 standards, the team developed process hierarchy maps to guide the design phases and reporting functionality of additional electronic applications. Member of the SAP implementation team as Manufacturing operations lead. Responsible for 1. collecting and communicating user requirements and business process needs, and 2. Defining integration needs in anticipation of future applications such as MES and data analytics.

Framingham, Ma

Member of build-out team for strategic cell culture plant responsible for digital technology for manufacturing. Project manager of Werum MES implementation delivering electronic batch records, materials management, equipment management. Acted as site representative for the Operations Systems Team. Executed digital strategy in alignment with MES Center of Excellence policies and roadmap. Coordinated and managed project activities with Manufacturing, Quality, Validation, Engineering, and IT. Experience managing resources (internal, vendor, and consultants), and budget. Consulted with technical personnel and maintained alignment with MES deployment across international sites. Additional projects: Definition of User requirement specifications for data analytics systems and OSI PI historian. Managed a compliance improvement project towards resolution of compliance records. Led the implementation of infrastructure and OSI PI historian for automated data acquisition for chromatography processes.

Framingham, Ma

Supported production operations for Sterile Hyaluronic Acid and bioresorbable membranes in the Sepra family of products. Led the implementation and use of data analytics systems for process monitoring (biologics, devices and oral dose). Established program for periodic and continuous process data review for Biosurgery and downstream process of biologics at commercial scale and in alignment with Integrated Control Strategy. Responsible for user training and deployment of system to multiple manufacturing sites. Supported technology transfer, facility expansion, and performed process improvement initiatives and investigations, CAPA and deviation resolution. Responsible for critical Quality management effort for audits by ISO certifying entities, FDA, and international regulators.

Massachusetts, United States

Process support to Genzyme's manufacturing operations in Biosurgery and General Division. Responsible for process monitoring, investigations and CAPA resolution. Performed root cause analysis, supported audits, identified areas of improvement.Established the practice of CPV in alignment with company Quality practices.

Executive Education Women In Leadership Certificate Program (Ongoing)

Ph.D., Biosystems Engineering

Research Assistant in machine vision systems and engineering modeling and simulation of drying processes.

Ms, Food Science And Technology

Activities and Societies: Institute of Food Technologists (IFT)Research Assistant: protein extraction.

B.Sc., Chemical Engineering