Carlos Hernandez

About Carlos Hernandez

Self-motivated and forward-thinking leader with 20+ years pharmaceutical industry experience (Brand and Generic Rx (ANDA and NDA products)) and strong track record and demonstrated expertise in bringing new pharmaceutical products to marketplace. Knowledge of the drug development process from early-stage through regulatory approval, including post approval technical support for marketed products. Experienced in directing development activities (formulation, process, and packaging). Pharmaceutical process engineer with proven track record of leadership and execution coupled with strong technical background and hands-on pharmaceutical development experience. Expertise in managing and executing R&D Product & Process Development and technology transfer projects interfacing with Manufacturing & Quality Operations. Experience in leading and building pilot plant product manufacturing teams engaged in early development at global level (U.S. and Japan). Strong emphasis on establishing effective relationships with key partner groups and leading in a matrix environment. Strong communication skills, building working relationships and team building. Demonstrated experience in the following areas: • Immediate & Modified Release (CR/SR/ER) Solid Oral Dosage Formulations • Ointment and Cream Dosage Forms • Solid Oral Dosage Forms process technologies (fluid bed granulation/drying, high shear granulation, roller compaction, fluid bed particle and tablet coating, blending, compression, encapsulation, tablet pan film coating) • Technology Transfer & Commercialization • Process & Cleaning Validation • Clinical Trials Material (CTM) Manufacturing • Capital projects & Equipment Qualification (IQ, OQ, PQ)

Experience

1. Facilities Maintenance Manager

   Eikon Therapeutics

   May 2022 — Present · Hayward, CA, US

Education

• De Anza College

  Metrology