Augusto Piazza
Senior R & d Chemist @Mozarc Medical
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WORK HISTORY
Senior R & d Chemist @Mozarc Medical
Manage clinical and pilot‑scale GMP manufacturing, ensuring robust processes, accurate documentation, and full regulatory compliance, including requirements for sterile product development in alignment with EU GMP Annex 1.Lead the technical transfer of drug products to internal and external manufacturing sites, coordinating multidisciplinary teams and ensuring smooth scale‑up, operational readiness, and adherence to sterile manufacturing principles where applicable.Draft, review, and validate audit‑ready technical documentation (MBRs, guides, specifications, technical/quality agreements), manage TMF/eTMF, and support regulatory submissions, ensuring alignment with GMP and Annex 1 expectations for sterile products.Optimize terminal sterilization processes and support process design through structured evaluations, data analysis, and risk‑based methodologies, contributing to the development and validation of sterile drug products.Provide on‑site shopfloor support and operator training on processes, GMP, and contamination control principles.Offer technical input for formulation development in line with ICH Q8, Q10, and Q12, supporting lifecycle‑based decision‑making with a specific focus on sterile product requirements and contamination control strategies.Manage laboratory orders and material flows through SAP, coordinating supplier qualification and approvals to ensure continuity and compliance across operations.Collaborate closely with QA, Regulatory Affairs, Validation, Microbiology, and Supply Chain to ensure consistent alignment across quality, technical, and operational functions.Handle QA approval of R&D materials, investigate deviations, and implement corrective actions to maintain high standards of quality and process integrity, contributing to contamination control and sterility assurance.
EDUCATION
University of Rome Tor Vergata
Bachelor's degree, Biotechnology
Sapienza Università di Roma
Master's degree, Industrial and Environmental Biotechnology
SKILLS
ABOUT AUGUSTO PIAZZA
Life Science professional with 6+ years of experience in R&D, validation, and audit‑ready documentation within regulated environments (GMP, GAMP 5, FDA, AIFA). I specialize in bridging technical, regulatory, and operational domains, ensuring data integrity, process robustness, and compliance across the full product lifecycle.My motto — “You must keep running just to stay in place” — reflects my continuous drive for growth, learning, and new professional challenges.
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