Upon graduating with a Bachelor of Science in industrial chemistry from the University of Puerto Rico in 1997, Melvin Colón launched his accomplished career at McNeil Consumer Products, Inc., where he performed analytical testing. He subsequently joined Searle & Co. and became involved in the Quality Control lab; he would continue to find success in this environment at a pharmaceutical company for nearly two years. By 2000, he was selected as one of the best chemists to participate in the launch of the medication Celebrex, which was manufactured in Puerto Rico, into the global market. He went on to review batch records for the QC lab, manufacturing, and packaging; he also worked in the manufacturing area, focusing on process validation and equipment qualification.

Throughout these responsibilities, Mr. Colón also worked for Dutch Pharmaceuticals and bolstered his own credentials by earning a master’s in engineering. He swiftly transitioned into the consulting field, his expertise sought after across several companies, including Pharmacia Corporation, McNeil, Cardinal Health, and RCM Technologies, Inc. He eventually transitioned into project management, where he managed a project in Puerto Rico that included 55 resources and had a budget of $50 million for equipment validation and commissioning. Since then, he’s been immersed in the Quality Assurance field for the last 15 years—working as a specialist for numerous pharmaceutical companies, a consultant and an auditor for medical device companies, and a QA Lead at JI Solutions and The Luttrell Group. Since 2020, Mr. Colón has been active as a senior QA consultant and project manager at 5Ws Consulting, senior QA consultant at the Gintegra Group, the head of QA at Buoyant Pharma, and a QA consultant at Anobri Pharmaceuticals US, LLC, NATCO Pharma Limited, and LST Consulting USA.

Since 2024, Mr. Colón has excelled as a Senior QA Consultant at the Henrici Group and the FDA Group, LLC. At the latter company, he’s currently working with a client in Mexico who manufactures vaccines. Providing support and identifying gaps in their processes, he proposed an alternative approach, which was accepted. As a result, they’re planning to conduct a small internal audit to assess their various systems. Additionally, he’s responsible for the validation of equipment, facilities, activities, and quality systems. Among his various other full-time and short-term projects, he recently conducted an assessment for a client in Korea, a cosmetic facility that received regulatory information from the FDA. He also worked on a project in Memphis, Tennessee, where a clinical site was converted into a commercial facility—he led two teams, one focused on government control and the other on quality systems. He was responsible for updating the quality system, conducting audits, and implementing new procedures to meet FDA commercial requirements.

Looking toward the future, Mr. Colón strives to make a significant impact in the pharmaceutical industry. Instead of waiting for companies to receive an FDA Form 483 as a result of inspection issues, he wants to collaborate with them to ensure they’re adequately prepared for inspections. His goal is to help those companies avoid receiving negative observations. Ultimately, he wants to ensure that they deliver the right product to patients on the first attempt. Achieving a lack of observations means that they can release their products to the market successfully from the beginning. To aspiring consultants in the field, he advised how essential it was to showcase one’s expertise and extensive knowledge in the field, saying, “You must cultivate a sense of trustworthiness, ensuring that your clients feel confident in your abilities.”