Mivis Fornos

Mivis Fornos, PhD, has extensive work experience in the pharmaceutical industry. Mivis started their career as an Analytical Chemist at Biological-Pharmaceutical Laboratories, where they developed and validated methods for pharmaceutical drugs and conducted stability studies. Mivis then worked at SPCEN XXI INVEST as an Analytical Chemist, focusing on method development and validation for biological samples to support safety studies in animals. At Azopharma Product Development Group, they were a Scientist responsible for executing method validation activities using various analytical methodologies.

Dr. Fornos joined Noven Pharmaceuticals as a Research Scientist and later as a Sr. Scientist, where they developed bioassay methods by LC-MS/MS and ELISA for quantification of small molecules and small peptides in plasma. Mivis also evaluated macromolecules for enteral dosing delivery technology. Mivis re-joined Noven Pharmaceuticals in 2020 as a Sr. Scientist, leading analytical projects and independently working on various projects and interdepartmental collaborations.

At Goodwin Biotechnology, Inc., Dr. Fornos worked as a Quality Control Analyst, focusing on authoring technical and regulated documents, conducting method development and validation activities for therapeutic products, and performing separation and analysis of monoclonal antibodies using chromatographic techniques.

Mivis then joined Aveva Drug Delivery Systems as an Analytical Scientist III, where they interacted with FDA inspectors during inspections, authored submission reports, and collaborated with cross-functional teams to ensure compliance with quality and regulatory requirements.

Most recently, Dr. Fornos worked at Catalent Pharma Solutions as a Sr. Scientist, leading multiple client projects and executing validation of analytical procedures. Mivis compiled and analyzed stability data and maintained GMP records in compliance with regulations.

Throughout their career, Dr. Fornos has demonstrated strong leadership, versatility, and the ability to achieve business goals and performance expectations. Mivis has expertise in method development and validation, regulatory compliance, and interdepartmental collaboration.

Mivis Fornos, PhD, has an extensive education history in the field of biomedical sciences, as well as additional certifications in project management, writing, and regulatory affairs.

In 1990, Mivis Fornos earned a Bachelor of Science (B.S.) degree in Chemical Engineering from the Polytechnic University in Havana, Cuba. This degree is valid in both Cuba and Spain.

Continuing their education, Mivis Fornos pursued a Doctor of Philosophy (PhD) degree in Biomedical Sciences, General from the Universidad de León. This program started in 2002 and was completed in 2006.

To further enhance their expertise, Mivis Fornos engaged in a Continuing Education program in Clinical Research from Medical Research Management in 2017. This program awarded them a 140-hour Certification.

In 2022, Mivis Fornos pursued additional Continuing Education from RAPS Online University, specializing in Regulatory Affairs. They obtained a Regulatory Affairs Certificate in Pharmaceuticals.

Mivis Fornos has also acquired several certifications to complement their education. In 2022, they became a member of the Regulatory Affairs Certification Program (RAPS) and obtained the Regulatory Affairs Certificate in Pharmaceuticals. In 2023, they obtained certifications in Project Management Foundations: Budgets and Writing White Papers from LinkedIn.