JP

Joseph Leonetti, Ph.D., PMP

Director, CMC Project Management at 4D Molecular Therapeutics

Joseph Leonetti, Ph.D., PMP has a diverse work experience in project management and leadership roles in the pharmaceutical and biotechnology industries.

Joseph currently works at 4D Molecular Therapeutics as the Director of CMC Project Management, where they collaborate with the SVP of Technical Operations to ensure that the CMC teams and contract manufacturing organizations (CMOs) stay focused and achieve the company's goals for IND submissions and gene therapy medications. Joseph is also responsible for communicating the progress to internal and external stakeholders.

Prior to their current position, Joseph was an Associate Director of CMC Project Management at 4DMT, where they played a role in the company's commitment to innovation in gene therapy. Joseph contributed to the development of novel AAV vectors tailored for the treatment of rare diseases with high unmet medical needs.

Before joining 4DMT, Joseph worked at Pfizer (formerly Medivation) as a Senior Project Manager. Joseph played a crucial role in successfully transferring CMC activities from BioMarin to Medivation and then to Pfizer. Joseph closely collaborated with the CMC Team Leader and managed a highly-functioning team to identify and resolve issues in order to meet clinical goals and milestones.

Joseph also gained valuable experience at Genentech, where they served as a CMC Project Manager. Joseph managed local and global cross-functional teams for various types of therapeutic products, including monoclonal antibodies, fragmented antibodies, antibody-drug conjugates, and small molecules. Their responsibilities included aligning CMC activities with device, clinical, and commercial requirements, as well as stakeholder needs.

Prior to Genentech, Joseph worked at Novartis (formerly Chiron) as a CMC Project Manager. Joseph managed a global team for the European BLA submission of the biological antibiotic CUBICIN and led the pre-IND through Phase 2 development and GMP manufacturing activities for dovitinib. Joseph also interacted extensively with international colleagues and contract manufacturing organizations.

Joseph began their career at Emerald Pharmaceuticals as a Consultant and later as a Senior Scientist. Joseph evaluated potential projects, optimized processes, and provided technical oversight for contract manufacturing in a cGMP facility.

Additionally, Joseph worked at Corus Pharma as a Process Development Manager, where they oversaw global project management and technical aspects of cGMP contract manufacturing, packaging, and labeling to support clinical trials utilizing a novel inhalation device.

Early in their career, Joseph worked at CombiMatrix as a Scientist and later a Senior Scientist. Joseph played a key role in the development of DNA microarray technology and implemented a novel method for quality control testing.

Overall, Joseph Leonetti, Ph.D., PMP has extensive experience in project management, CMC activities, and cross-functional team leadership in the pharmaceutical and biotechnology industries.

Joseph Leonetti, Ph.D., PMP has a solid educational background in the field of Chemistry. Joseph received their Bachelor of Science degree in Chemistry from the University of San Francisco. Joseph then went on to pursue their Doctor of Philosophy (Ph.D.) in Organic Chemistry at UC Santa Barbara.

Continuing their educational journey, Joseph engaged in postdoctoral studies at the University of Cambridge, specializing in Organic Chemistry & Polymer Science.

Furthermore, Joseph has also obtained a certification as a Project Management Professional (PMP) from the Project Management Institute in 2013.

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Timeline

  • Director, CMC Project Management

    March, 2022 - present

  • Associate Director CMC Project Management

    April, 2019

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