<div class="content-intro">Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work. </div><h3>Responsibilities</h3> <ul> <li>Oversee technical activities at drug product CDMOs including clinical trial material (CTM) production, process troubleshooting, risk assessments, registration batch production, and process validation</li> <li>Provide technical and scientific direction to CDMOs and external laboratories to ensure project deadlines and performance standards are met</li> <li>Responsible for technical leadership in issue resolution with CDMOs, including formulation challenges, technical transfer, design of experiments, and interpretation of results</li> <li>Lead the development/optimization of scalable, efficient, and cost-effective processes to produce CTM while ensuring product quality</li> <li>Lead process validation activities and strategies including establishing and evaluating process characterization plans, overseeing execution at CDMO, reviewing and approving CDMO reports</li> <li>Oversee the preparation of manufacturing batch records, technical reports, data summaries and CMC related documents required for various regulatory submissions</li> <li>Coordinate with Quality and Supply Chain teams to ensure timely manufacture and release of drug product lots by leading technical reviews of batch records, deviations, change controls, and nonconformance investigations; proactively identify and mitigate risks related to clinical supply</li> <li>Manage related SOPs, change controls, deviations and CAPAs with thorough knowledge of Good Manufacturing Practices</li> <li>Ensure adherence to applicable regulations and guidelines, including FDA, EMA, ICH, GCP, and GMP</li> <li>Author and review CMC sections of regulatory filings, including INDs, IMPD/IND amendments, and NDA/MAA submissions</li> </ul> Education, Experience & Skills Requirements <ul> <li>PhD in chemistry, pharmaceutical sciences, or rel

Sr. Director/ Exec. Director- CMC, Drug Product

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