Melvin Flores
About Melvin Flores
Melvin Flores is a Senior Manager in Analytical Development and Quality Control at Aimmune Therapeutics, with extensive experience in overseeing FDA validation activities and managing Contract Research Organizations. He has a background in biochemistry and has worked in various roles across the pharmaceutical industry, contributing to the successful submission of multiple drug applications.
Work at Aimmune Therapeutics
Melvin Flores currently holds the position of Senior Manager in Analytical Development and Quality Control at Aimmune Therapeutics. He has been with the company since 2020 and is based in Brisbane, California. In this role, he oversees validation activities for multiple products submitted to the FDA for approval. His responsibilities include managing the entire process from active pharmaceutical ingredient (API) validation for prototype batches to the final validation of the exhibit batch used for submission.
Education and Expertise
Melvin Flores earned a Bachelor of Science (B.S.) degree in Biochemistry from the University of California, Riverside. His educational background provides a strong foundation for his expertise in method development, particularly utilizing Design of Experiments (DOE) and Quality by Design (QbD) methodologies. He specializes in verification and validation processes, contributing to his proficiency in the pharmaceutical industry.
Background in Pharmaceutical Industry
Before joining Aimmune Therapeutics, Melvin Flores worked at several notable companies in the pharmaceutical sector. He served as a Scientist II at Amneal Pharmaceuticals from 2016 to 2020, where he developed skills in oversight and management of Contract Research Organizations (CROs). Prior to that, he was an Independent Consultant at Impax Laboratories from 2013 to 2016, addressing FDA 483s and warning letters. His earlier experience includes working as an LTS Scientist II at Actavis (now Allergan) from 2010 to 2013.
Achievements in Drug Development
Throughout his career, Melvin Flores has successfully contributed to the submission of several Abbreviated New Drug Applications (ANDAs). He provided strategic and technical support to development and validation activities at various stages of drug development. His extensive involvement in the remediation of over 250 drug substance and drug product test methods highlights his capability in addressing regulatory compliance and quality assurance.
Technical Skills and Knowledge
Melvin Flores possesses extensive knowledge of current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), United States Pharmacopeia (USP), and International Council for Harmonisation (ICH) guidelines. He is experienced in cleaning verification and validation, as well as multivariate data analysis using software tools such as JMP, Excel, and Minitab. His technical skills extend to running, troubleshooting, and enhancing methods for a wide range of laboratory instruments.