Pedro A. Moura Email & Phone Number

Brentford, Middlesex, Gb

• Provide global technical leadership for advancing vaccine platform technologies within the MSAT organization, coordinating with MSAT site teams to establish and maintain essential technical capabilities aligned with evolving business needs.• Define and drive platform technology strategies in collaboration with cross-functional partners across Global Supply Chain (GSC), R&D, Engineering, and Quality to support vaccine product portfolio growth and pipeline requirements.• Operate as a vital member of the MSAT Vaccines Leadership Team, representing vaccine platform technology needs at an enterprise level and leading initiatives to drive innovation across the manufacturing landscape.• Offer strategic recommendations for the vaccines portfolio, including new and existing products, ensuring the adoption of platform approaches where necessary to support scalability, efficiency, and compliance.• Serve as the primary contact within the MSAT organization for vaccine platform technologies, coordinating with internal stakeholders and external partners to secure specialist support for platform and product advancements.• Influence senior business leaders across GSC, Strategy, and R&D to align on platform requirements and deliver priority initiatives for new product introductions and manufacturing modernization.• Spearhead the integration of smart manufacturing technologies, including robotics, digital solutions, and artificial intelligence, to enhance process capabilities and support the organization's quality, safety, and operational efficiency goals.• Ensure alignment of MSAT's technical capabilities with the demands of the R&D pipeline, enabling rapid and efficient response to market demands and regulatory requirements for novel vaccines.

Philadelphia, Pa, Us

•Led, directed, and managed comprehensive upstream process development activities, encompassing vector engineering, plasmid design and manufacture, cell line development, cell culture, media development, process analytical technology (PAT), and process modeling.• Provided expert technical and managerial guidance to the 34 members of the Upstream Process (USP) team, ensuring timely and high-quality progress across all pipeline projects. Oversaw projects from early-stage development through late-stage development to commercial filing and approval.• Managed the scaling up and tech transfer of developed processes to both internal and external non-GMP and GMP manufacturing facilities.• Offered strategic prioritization for upstream technology platform design, focusing on continuous improvement in vector engineering, cell line development, plasmid manufacture, and cell culture process development.• Established and managed the upstream technology roadmap, driving the implementation of new technologies to support the industrialization of gene therapy.• Supported regulatory filings, health authority meetings, inspections, and other interactions as required, ensuring compliance and successful navigation of regulatory processes.

Rahway, New Jersey, Us

• Spearheaded the Microbial Vaccines Process Development sub-organization, overseeing critical programs such as Gardasil (HPV), Pneumovax23, Pedvax, Recombivax HB, and the commercialization of Pneumococcal Conjugate Vaccines (Vaxneuvance (PCV15) and PCV20+).• Led the Gardisal9 process improvement team, driving enhanced mechanistic understanding and yield improvements for the second-generation HPV process.• Co-led the CMC Digital Realization Team (MRL R&D, MMD Commercialization, and IT), accelerating the commercialization of clinical programs with a unified data management strategy across the enterprise.• Developed, implemented, and managed the Vaccines Operations and Automation Group, centralizing and standardizing work for efficiency gains in lab operations, business standards, and digital integration. Achieved a 15% productivity increase, resulting in >$2MM in cost savings/avoidance, and managed a $44MM departmental budget.• Managed up to 13 direct reports, serving as a manager of people managers, and led a group of 54 FTEs and 26 contractors.• Represented vaccines on the Covid Task Force, aligning pandemic responses and plans at the West Point site to support continued work and advancement of pipeline programs.• Recruited and hired over 40 new team members to support the vaccines organizational growth strategy for inline and pipeline program development.• Led a Live Virus Vaccine (LVV) Development and Process Characterization team, supporting an oncolytic virus (V937, CAVATEK (Viralytics)), and two COVID Vaccine candidates from IAVI and Themis (V590 and V591).• Acted as the Tech Transfer and Manufacturing Design Lead for the retrofit of manufacturing facilities to support Covid-19 Vaccines Programs (aseptic). Responsibilities included process flow design, review of URSs, process control strategy, PQ strategy, development of the Emergency Use Strategy, validation strategy, and BLA filing strategy.

Rahway, New Jersey, Us

Biologics Process Engineering Global Vaccines & Biologics Commercialization • Played a pivotal role as the Upstream Technical and Process Support Lead, driving the design, construction, and qualification of the Ketyruda® drug substance manufacturing process and future biologics programs at the MSD Biotech Dublin site.• Formulated a comprehensive strategy for data acquisition, integration, and analysis to facilitate the manufacture of biologics at the MSD Biotech Dublin site, laying the foundation for future digitalization, process monitoring, and modeling.• Contributed to the development of Factory of the Future (FoF) capabilities and design, particularly for the continuous manufacturing process of biologics, through a collaborative effort with Merck Research Laboratories (R&D MRL).• Provided technical support for the collaboration with JUST Seattle, focusing on the demonstration and development of a pilot-scale continuous manufacturing biologics drug substance (DS) process.• Served as the Technical Representative for key initiatives, including the Quality System Improvement Program (QSIP), Biologics Training Development Group, and the COMPLY Quality Committee, demonstrating a commitment to quality and continuous improvement.

Rahway, New Jersey, Us

Commercialization Project Management/Technology TransferBioprocess Development and Commercialization (BPDC)Global Vaccines and Biologics CommercializationTechnical Transfer Lead for Keytruda Manufacturing Process to CMOFunctional Learning and Development Lead for Biologics CommercializationQuality System Improvement Program Deployment Functional Lead for Global Vaccines and Biologics Commercialization

Rahway, New Jersey, Us

Associate Director, Bulk Fermentation and Upstream Manufacturing Lead, Upstream Process Development, Technical Operations, Merck Manufacturing Division, Merck & Co., Inc., Elkton, VA.• Pre-Approval Inspection (PAI) readiness team member for MK-1293. • Provide scientific/engineering technical floor support for the manufacturing of MK-1293. Responsibilities include scheduling, authoring deviations, improving process consistency, training engineers, change controls, and tracking and trending of manufacturing performance data• Quality by Design (QbD), Process Characterization, and Design of Experimentation (DoE)• Microbiological manufacturing support (sterile boundary investigations, qualification/validation testing, and microbial monitoring and characterization)

Rahway, New Jersey, Us

Sr. Specialist Process Engineer, Upstream Manufacturing Lead, Head of the Strain Development and Upstream Process Development Lab, Vaccine and Biologics Development and Technical Operations, Merck Manufacturing Division, Merck & Co., Inc., Elkton, VA.• Led a post-launch productivity improvement program (MK-1293 L+) to increase production yield (> 20 Kg/batch, >80% primary recovery yield (28% improvement over launch metrics) to reduce the cost of production of MK-1293 through the redevelopment of the fermentation and primary recovery process • Provide scientific/engineering technical floor support for the manufacturing of MK-1293. Responsibilities include scheduling, authoring deviations, improving process consistency, training engineers, and tracking and trending of manufacturing performance data • Authored multiple sections for the World Marketing Application for MK-1293 (Cell Substrate, Cell Banking and Characterization, Upstream Process Controls, Upstream Manufacturing Process Development, Intermediate Process Hold Studies and Residual Host DNA)• Pre-Approval Inspection (PAI) readiness team member for MK-1293. • Developed the Cell Bank Stability Plan and Continual Performance Evaluation Strategy for MK-1293 • Manage 10 engineers in the bulk manufacturing of MK-1293 for commercial supply build • Led the Tech. Transfer of the Upstream Process to Samsung Bioepis (Korea)• Provide technical and scientific support to novel Biologics programs (MRL)• Filed four invention disclosures • Microbiological manufacturing support (sterile boundary investigations, qualification/validation testing, and microbial monitoring and characterization)• Science and Technology Day Poster Prize Winner (2014), Award of Excellence (2015)

Rahway, New Jersey, Us

Bioprocess Development Lead/Upstream Process Lead, Head of the Strain Development Lab, Vaccine and Biologics Development and Technical OperationsStrain, Fermentation and Process Development for the Commercialization of Biologics.Genetic engineering, strain improvement, shake flask model development, fermentation process characterization and improvement (E. coli, P. pastoris, S. cerevisiae and CHO), medium formulation and improvement, multivariate statistical methods (DoE), biomolecular and biochemical assay development, and protein purification. • Led the early stage development program of a therapeutic protein MK-8532 for manufacturing (strain development, upstream process development (fermentation and primary recovery), and downstream process development)• Led a post-launch development program for MK-1293 to increase production yield and efficiency• Perform and execute strain development, fermentation experiments and process development work as part of process understanding, characterization and trouble shooting studies to aid manufacturing and R&D groups within Merck (Microbial and Eukaryotic)• Development and implementation of novel technologies to support and improve the production and characterization of biologics• Creation of GMP cell banks, and cell bank and end-of-production characterization studies• Authored multiple sections of INDs, Quality Notifications, technical memos, development memos, qualification protocols, validation reports, SOPs, tech. transfer documents and invention disclosures• Design, development and validation of analytical reagents and assays for in-process and product release testing (HSP, SCP and qPCR)• Microbiological manufacturing and processing support (sterile boundary investigations, qualification/validation testing, and microbial monitoring and characterization).• Science and Technology Day Poster Prize Winner (2013) and Director’s Award (2012)

Cincinnati, Ohio, Us

• Developed and validated rapid microbiological methods aligning with cGMP and USP guidance for raw material, finished product, developmental formulations screening, preservative efficacy testing (MST), microbial identification, and product claims support. Leveraged technologies such as MassSpec ID, Soleris, Flow Cytometry, RiboPrinter, MicroBeta2 Plate Counter, Spiral Plater, Pathatrix, qPCR, and Fluorescent Microscopy.• Enhanced organizational capabilities by introducing a flow cytometric High-Throughput Screening (HTS) platform for microbial population analysis, enumeration, and novel preservative screening (IC50). Established an advanced Microbiological Fluorescence and Differential Interference Contrast (DIC) Microscopy Lab.• Developed multiple methods for the evaluation and development of Bifidobacterium infantis fermentation, lyophilization, enumeration, and population analysis, specifically for Align® Probiotic.• Designed and implemented a 7-hour Salmonella antibody-based sample prep method (Pathatrix) and validated a qPCR detection assay for product release testing (ABI) for Iams and Eukanuba products.• Authored validation reports, protocols, and executive summaries, showcasing a commitment to documentation and reporting standards.• Acted as a matrix manager for 3 Scientists and 2 Contractors, demonstrating leadership and team management skills.• Advanced the development and understanding of a novel microbial diagnostic DNA biochip capable of detecting genomic DNA from pathogenic organisms (genosensor), resulting in a patented technology.• Represented Future Works (P&G Venture Group) as a microbial and molecular technology due diligence representative.• Served as a Parenteral Drug Association (PDA) representative from 2010-2011 and chaired the Rapid Microbiologic Technologies Section at the Annual Global Conference in 2011, contributing to industry knowledge and advancements.

• Development and screening of transmission blocking anti-malarial drugs against gametocyte stages• Investigating the mode of action of transmission blocking agents

New York, New York, Us

• Experimentally proved the use of bioinformatics with the identification of a post-translation signal sequence that directs protein trafficking in the malarial parasite • Characterized the development, location and function of several newly identified malarial proteins• Wrote manuscripts and assisted with grant preparation• Mentored Columbia University/Barnard College undergraduates to improve their experimental techniques

Bronx, New York, Us

Taught class, prepared and administered exams, and organized tutorials to clarify materials for 50+ students.

Ph.D., Microbiology And Immunology

Research Commercialization (Technology Venture)

Accounting And Economics

Business Development And Technology Transfer

Doctor Of Philosophy (Ph.D.), Microbiology And Immunology

M.S., Biomedical Sciences

B.S., Biology