Heriberto Martinez

Senior Scientist at Amgen

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Heriberto Martinez's Summary

20+ years of experience developing and executing strategies (within manufacturing and quality groups) to supply pharmaceutical products through technical and manufacturing leadership. Drives cross-functional efforts to deliver outstanding results in New Product Introductions (NPI) the launching, establishing, expanding and improvement of products, manufacturing processes, Quality Systems and manufacturing facilities. In-depth technical and regulatory experience of Global Technology Transfers, Start-Ups, New Products Development & Product Launches as well as Quality Systems. Strong Quality and Regulatory skills to ensure compliance within current FDA requirements. Experience working on GAP Analysis and Remediation Plans in a facility under an FDA Warning Letter. Worked with plant management and corporate quality organization and third party company (Quantic, Lachman Consultants, Kemper-Masterson Inc (KMI) and Parexel Consultants) to improve site procedures and systems (Quality Compliance Enhancement Program) which led to removal of the plant Warning Letter designation and approval of new products. Specialties: Manufacturing Sites Operations, Quality Control Laboratory, Implementing Sustainable Quality Systems, Analytical Development, Process Validation, Cleaning Validation. Start-ups, Technical Services, Technology Transfer, Change Control, CAPA, Root Cause Analysis, Quality Engineering, Lean Six Sigma, Pharmaceutical manufacturing, process improvement, Statistical Process Control (SPC), Solids Dosage, Semisolids, MDI, aerosols