<div class="content-intro"><p><span style="text-decoration: underline;"><strong><span data-contrast="auto">Mavericks Wanted</span></strong><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></span></p> <p><span data-contrast="auto">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</span> <br><span data-contrast="auto"> </span> <br><span data-contrast="auto">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. </span> <br><span data-contrast="auto"> </span> <br><span data-contrast="auto">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.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></p></div><h3><u>What You'll Do</u></h3> <p>Manage quality oversight at Drug Product Contract Manufacturing Organizations (CMOs). Act as QA operations lead with assigned CMOs, including review of manufacturing batch records and batch release certificates. Ensure CMO SOPs and Master Batch Records are in compliance with cGMPs and serve as technical review for deviations, change records, protocols, and CAPAs generated from or pertaining to Calcilytix or other BridgeBio affiliates, as needed.</p> <p> </p> <h3><u>Responsibilities</u></h3> <ul> <li style="color: #494949 !important;"><span style="color: #494949;">Represent QA Operations on internal and external project teams, audits and inspections, and participate in monitoring of CMO performance</span></li> <li style="color: #494949 !important;"><span style="color: #494949;">Review and manage master and executed manufacturing batch records from CMOs, including release activities, and related documents such as specifications, analytical and microbiological methods, stability study/protocols, process and method validation protocols and reports</span></li> <li style="color: #494949 !important;"><span style="color: #494949;">Author and perform quality review of SOPs and quality events (deviations/investigations, OOSs/OOTs, change controls, supplier notifications, etc.)</span></li> <li style="color: #494949 !important;"><span style="color: #494949;">Lead Disposition of Drug Product</span></li> <li style="color: #494949 !important;"><span style="color: #494949;">Communicate/escalate manufacturing deficiencies/non-conformances to management, present issues during escalation, and work with CMOs to ensure timely resolution</span></li> <li style="color: #494949 !important;"><span style="color: #494949;">Support review of regulatory filings</span></li> <li style="color: #494949 !important;"><span style="color: #494949;">Support audit of CMOs</span></li> </ul> <p> </p> <h3><u>Where You'll Work</u></h3> <p>This role requires in-office collaboration 2-3x per week in our San Francisco office.</p> <p> </p> <h3><u>Who You Are</u></h3> <ul> <li style="color: #494949 !important;"><span style="color: #494949;">Bachelor's Degree in a science discipline with 8+ years of experience within a biopharmaceutical company, or contract research organization</span></li> <li style="color: #494949 !important;"><span style="color: #494949;">Strong knowledge of GMP, SOPs, Quality Systems (e.g. Lot Release, Deviation, Change Control, CAPA,) ICH and GxP principles</span></li> <li style="color: #494949 !important;"><span style="color: #494949;">Strong knowledge of FDA and other clinical trial regulations</span></li> <li style="color: #494949 !important;"><span style="color: #494949;">Prior experience in QC, Analytical Development and process validation highly desired</span></li> <li style="color: #494949 !important;"><span style="color: #494949;">Excellent verbal and written communication skills, with strong customer focus</span></li> <li style="color: #494949 !important;"><span style="color: #494949;">Excellent organizational skills, ability to manage multiple tasks and competing priorities, and maintain meticulous attention to detail</span></li> <li style="color: #494949 !important;"><span style="color: #494949;">Travel up to 10% total time</span></li> </ul> <p> </p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><div> <div>At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated sal