<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><strong><u>Company Overview</u></strong></h3> <p><em>Calcilytix</em></p> <p> </p> <p><strong><u>What You’ll Do</u></strong></p> <p>You will be responsible for the oversight of commercial drug product manufacturing at contract manufacturing organizations while facilitating global commercial drug product disposition. You will also work with colleagues in CMC, Supply Chain Operations, Quality Assurance and CMC-regulatory Affairs, while serving as an important point of technical contact between Calcilytix and contract manufacturing organizations.</p> <p> </p> <p><strong><u>Responsibilities</u></strong></p> <ul> <li> <p>Person-in-plant oversight of the clinical and commercial drug product manufacturing process at CMOs (especially for small molecule solid oral dosage forms)</p> </li> <li> <p>Perform activities related to batch review & release</p> </li> <li> <p>Participate & provide input to root-cause analysis and CAPA plans</p> </li> <li> <p>Participate in process confirmations, change controls, & quality oversight</p> </li> <li> <p>Coordinate investigations at external sites related to OOS/OOT, deviations, and unexpected analytical results</p> </li> <li> <p>Perform trend analysis of testing and process data for commercial drug products and participate in continuous improvement projects</p> </li> <li> <p>Generate batch genealogy for commercial materials</p> </li> </ul> <p><em> </em></p> <p><strong><u>Where You’ll Work</u></strong><u> </u></p> <p>This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office. </p> <p><strong><u> </u></strong></p> <p><strong><u>Who You Are</u></strong></p> <ul> <li> <p>BA/BS degree in Life Sciences, Engineering, or related field required</p> </li> <li> <p>Minimum of eight (8) years of experience within the pharmaceutical industry required</p> </li> <li> <p>Solid understanding of CMC manufacturing and analytical activities required in commercial drug product manufacturing, including knowledge of cGMP regulations.</p> </li> <li> <p>Experience with cGMP quality oversight and on floor production support required</p> </li> <li> <p>Understanding of Quality Management Systems required</p> </li> <li> <p>Prior experience as a liaison with solid oral dosage form contract manufacturing organizations required</p> </li> <li> <p>Ability to periodically travel (up to 30%)</p> </li> </ul> <p> </p> <h3><u>Rewarding Those Who Make the Mission Possible</u></h3> <p> </p> <p>We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. </p> <p> </p> <p>Financial Benefits:</p> <p> </p> <ul> <li> <p>Market leading compensation </p> </li> <li> <p>401K with 100% employer match on first 3% & 50% on the next 2%</p> </li> <li> <p>Employee stock purchase program</p> </li> <li> <p>Pre-tax commuter benefits</p> </li> <li> <p>Referral program with $2,500 award for hired referrals</p> </li> </ul> <p> </p> <p>Health & Wellbeing:</p> <p> </p> <ul> <li> <p>Comprehensive health care with 100% premiums covered - no cost to you and dependents</p> </li> <li> <p>Mental he