Neshel Rodriguez Email & Phone Number

California, United States

Emeryville, California, United States

South San Francisco, California, United States

• Demonstrated leadership in overseeing the clinical production of adeno-associated virus (AAV)-based gene therapy substances, emphasizing stringent adherence to cGMP guidelines and regulatory compliance.• Directed technology transfer, equipment commissioning, process development, scale-up, and validation efforts, successfully launching an in-house cGMP manufacturing facility within a year.• Led cross-functional teams, conducting weekly meetings to monitor progress, plan schedules, identify potential risks, and implement mitigation strategies to ensure timely completion of project deliverables.• Oversaw the production of the first in-house Working Cell Bank (WCB), successfully manufacturing 1 lot to secure a sufficient cell supply to support future production needs.• Migrated crucial Technical Operations documentation into Veeva Systems, ensuring seamless transition and maintaining regulatory compliance for streamlined operations and improved documentation management.

• Served as the Vector Core Team Lead, delivering high-quality viral vectors to advance gene therapy research and support non-clinical projects, ensuring optimal results and project progression.• Trained and guided new Vector Core personnel in 3 months, resulting in the successful delivery of 200+ viral preparations in Q1 2021, significantly boosting the team's productivity and output.• Established toxicology manufacturing readiness by introducing production protocols, creating equipment SOPs, calibrating equipment, and performing Installation Qualification/Operational Qualifications (IOQs).• Directed the establishment of a 200L bioreactor and harvest process while managing the Route of Administration (ROA) and toxicology material manufacturing.• Managed the CMC laboratory by organizing biohazard waste collection, enhancing lab organization, establishing quarterly lab cleanings, and overseeing equipment maintenance.

Santa Clara, California

• Led manufacturing operations for the annual production of Master Virus Seed (MVS) and Clinical Trial Materials (CTM) for the FluMist/Fluenz vaccine.• Produced high-quality H1N1 (pandemic) vaccine raw material, MVS, and CTM, facilitating the timely delivery of the first-to-market vaccine during the 2009 H1N1 pandemic.• Contributed to a successful Pre-Approval Inspection for the Pandemic flu vaccine bulk production process and facility, resulting in FDA licensure and validation of the facility's capability to produce vaccines at scale.

Santa Clara, California

• Operated and maintained laboratory equipment to support Vaccine Clinical Manufacturing, ensuring equipment readiness and optimal performance during production activities.• Collaborated with cross-functional teams, including Quality Assurance, Process Development, Materials Management, Facilities, Metrology, and Quality Control.• Documented manufacturing processes and outcomes, ensuring accurate and compliant record-keeping in adherence to regulatory standards and internal protocols.