Edmond Massuda, MS
Senior scientist with more than 20+ years of experience advancing biologics, vaccines, and diagnostic technologies through complex analytical and regulatory challenges.
Ed brings has extensive experience collaborating with cross-functional teams, including CMC, manufacturing, quality, regulatory, and clinical groups, to achieve alignment of analytical approaches with program milestones and regulatory criteria. He has also managed scientific teams and resources and guided execution to produce high-quality results under demanding deadlines. His experience spans assay development, validation, tech transfer, and troubleshooting across complex biologics and vaccine programs, with strong ability to translate complex scientific data into insights for decision-making. In addition, he has specialized experience in implementing, configuring, and validating analytical software platforms, including Stegmann Systems PLA and SoftMax Pro GxP, supporting compliant data acquisition, analysis, and biostatistical evaluation in regulated environments.
Areas of Focus/Expertise
- Analytical Development
- Bioassay Development and Validation
- Immunoassay Optimization
- GMP/GLP/GCLP Compliance
- CMC Strategy
- Risk Mitigation
- Bioanalysis and Statistical Software Support
Selected Experience & Impact
Ed played a key role in advancing the Novavax COVID-19 vaccine from early development through clinical trials and FDA approval, contributing to assay strategy, potency-release testing, and the development and validation of clinical immunology assays. He helps organizations interpret complex immunology and analytical data to guide regulatory strategy, clinical development, and key program decisions. Focused on ensuring that analytical strategies are not just technically sound, but directly aligned with mechanism of action and the decisions a program needs to make at each stage.
Background & Credentials
Prior to FDA Partners, Ed held senior roles within the biotechnology and pharmaceutical industries advising multinational, mid-sized, and niche companies. He holds a MS in Oncological Sciences from the University of Utah and a BS in Genetics & Biochemistry from the University of Wisconsin. Ed thrives in fast-paced environments, helping guide organizations in optimizing assay performance, strengthening regulatory readiness, and advancing programs efficiently from development through commercialization.