Senior Manager, CMC – Manufacturing and R&D - San Diego, CA

<div class="content-intro"><p>Mirador Therapeutics, Inc. is a clinical-stage precision medicine company focused on developing first-and/or best-in-class next-generation therapeutics for immunology and inflammation. The company’s Mirador360™ precision development engine leverages the latest advances in human genetics and data science to rapidly deliver new precision medicines for patients living with immune-mediated inflammatory and fibrotic diseases. Mirador has raised over $650 million from leading life sciences investors and is based in San Diego, CA. Mirador was named Best Places to Work by Biospace and is a Great Place to Work-Certified™ Company.</p></div><p><strong>Summary</strong></p> <p>This position will be responsible for technical oversight of biologics development and manufacturing to deliver clinical trial supplies across multiple clinical biologics programs.</p> <p>Responsible for oversight of technical aspects of the biologics process development and manufacturing activities at contract manufacturing organizations (CMOs) including Cell Line/Master Cell Bank, Drug Substance, Drug Product, and Device development, scale-up, technical transfers, cGMP manufacturing, process characterization, validation, and delivery of launch supplies.</p> <p>Daily activities include oversight of cGMP activities occurring at CMOs, providing technical input to development activities and objectives, leveraging data generated by external service providers to enable strategic decision-making.</p> <p><strong>Responsibilities</strong></p> <ul> <li>Supports the CMC team in authoring Quality sections for global regulatory filings, answering regulatory inquiries and providing assessments for change management and/or deviation investigations.</li> <li>Reviews and provides active technical feedback to process development objectives, study design, and outcomes/data to drive scientifically rigorous development work at external CMO partners and achieves optimal development outcomes on accelerated timelines.</li> <li>Reviews and provides feedback to all documentation related to the cGMP production of biologics products including but not limited to process descriptions, master batch records, executed batch records, sampling plans, protocols, and reports. Provides technical oversight for all operational aspects of the manufacture of drug substance or drug product at CMOs.</li> <li>Implements and maintains a data management framework for standardization and internalization of development and cGMP manufacturing data for all of Mirador’s biologics programs.</li> <li>Identifies and executes deliverables to achieve readiness of mid-phase programs for pivotal batch manufacture, and for commercial launch.</li> <li>Navigates prioritization and completion of deliverables on critical DNA to IND