Puerto Rico
With over 20 years of work experience in the pharmaceutical and biotech industry. I have a bachelor's degree in mechanical engineering from the University of Puerto Rico-Mayaguez, and I have completed executive education programs at the Kellogg School of Management. I have developed and executed effective sales strategies, built and maintained strong client relationships, and delivered high-quality consulting and education services in various areas, such as FDA GMP, validation, quality system, and product transfer. I have also contributed to the technical transfer of sterile products and the qualification of various fill and finish facilities, demonstrating my expertise in sterilization and cleaning processes, aseptic simulation studies, and aseptic drug product manufacturing process. My core competencies include sales leadership, business development, project management, technical consulting, and team collaboration. I am passionate about helping clients achieve their regulatory, compliance, and quality goals, and I am always eager to learn new skills and technologies in the fast-changing and dynamic pharmaceutical and biotech industry. I value diversity, innovation, and excellence, and I strive to bring these values to every project and partnership I engage in.
Responsible for the product transfer and validation activities related to the technical transfer of a sterile product and the qualification of a new Fill and Finish Facility. Major responsibilities include: Master Plans, and the development, coordination and execution of protocols for characterization and validation activities for sterilization and cleaning processes, aseptic simulation studies, and aseptic drug product manufacturing process Equipment includes formulation tanks and transfer lines, isolators, filling equipment, part washers, CIP units, vial washers, vial tunnels, cappers.
Responsible for the product transfer and validation activities related to the technical transfer of a sterile product and the qualification of a new Fill and Finish Facility. Major responsibilities include: Master Plans, and the development, coordination and execution of protocols for characterization and validation activities for sterilization and cleaning processes, aseptic simulation studies, and aseptic drug product manufacturing process Equipment includes formulation tanks and transfer lines, isolators, filling equipment, part washers, CIP units, vial washers, vial tunnels, cappers.