Associate Director/Director, Drug Product Manufacturing

<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>What You'll Do</u></strong></h3> <p>You will be responsible for the oversight of drug product formulation and manufacturing process development and manufacturing at contract manufacturing organizations while facilitating clinical 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 research and manufacturing organizations.</p> <h3><strong><u>Responsibilities</u></strong></h3> <ul> <li>Formulation composition and manufacturing process development (experience with modified/extended release is a plus)</li> <li>Person-in-plant oversight of the clinical and commercial drug product manufacturing process at CMOs (especially for small molecule solid oral dosage forms)</li> <li>Perform activities related to batch review & release, deviations, change controls, investigations and other quality related work</li> <li>Participate & provide input to root-cause analysis and CAPA plans</li> <li>Author/update regulatory filings</li> </ul> <h3><strong><u>Where You'll Work</u></strong></h3> <p>This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office. Fully remote could be considered for the right candidate.</p> <h3><strong><u>Who You Are</u></strong></h3> <ul> <li>BS degree in Life Sciences, Engineering, or related field required, advanced degrees preferred</li> <li>· Minimum of twelve (12) years of relevant experience within the pharmaceutical industry required</li> <li>· Solid understanding of CMC manufacturing and analytical activities required in commercial drug product manufacturing, including knowledge of cGMP regulations.</li> <li>· Experience with cGMP quality oversight and on floor production support required</li> <li>· Understanding of Quality Management Systems required</li> <li>· Prior experience as a liaison with solid oral dosage form contract manufacturing organizations required</li> <li>· Experience with polymer characterization (rheology, DSC, TGA), dissolution, extrusion/spraying operations, and enteric coating preferred</li> <li>· Ability to periodically travel (up to 30% at times)</li> </ul> <p> </p> <p class="p1"><span class="s1" style="color: rgb(246, 235, 219);">#LI-NT1</span></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 salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.</div> </div></div><div class="title">Salary</div><div class="pay-range"><span>$158,000</span><span class="divider">—</span><span>$215,000 USD</span></div></div></div><div class="content-conclusion"><p><strong>As a global company, our comprehensive benefits may vary based on location.  <span data-contrast="auto">We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.</span></strong></p> <p><span style="text-decoration: underline;"><strong><span data-contrast="auto">For USA based roles:</span></strong></span></p> <p><strong><span data-contrast="none">Financial & Rewards </span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><strong><span data-contrast="none">Market-leading compensation</span></strong><span data-contrast="none">  </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><strong><span data-contrast="none">401(k) with employer match</span></strong><span data-contrast="none">  </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><strong><span data-contrast="none">Employee Stock Purchase Program (ESPP)</span></strong><span data-contrast="none"> </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><strong><span data-contrast="none">Pre-tax commuter benefits</span></strong><span data-contrast="none"> (transit and parking) </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><strong><span data-contrast="none">Referral bonus</span></strong><span data-contrast="none"> for hired candidates </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><strong><span data-contrast="none">Subsidized lunch and parking</span></strong><span data-contrast="none"> on in-office days </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <p><strong><span data-contrast="none">Health & Well-Being </span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><strong><span data-contrast="none">100% employer-paid medical, dental, and vision premiums</span></strong><span data-contrast="none"> for you </span><strong><span data-contrast="none">and</span></strong><span data-contrast="none"> your dependents </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><strong><span data-contrast="none">Health Savings Account (HSA)</span></strong><span data-contrast="none"> with annual employer contributions, plus </span><strong><span data-contrast="none">Flexible Spending Accounts (FSA)</span></strong><span data-contrast="none"> </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><strong><span data-contrast="none">Fertility & family-forming benefits</span></strong><span data-contrast="none"> </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none"> </span><strong><span data-contrast="none">Expanded mental health support</span></strong><span data-contrast="none"> (therapy and coaching resources) </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><strong><span data-contrast="none">Hybrid work model</span></strong><span data-contrast="none"> with flexibility </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><strong><span data-contrast="none">Flexible, “take-what-you-need” paid time off</span></strong><span data-contrast="none"> and company-paid holidays </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><strong><span data-contrast="none">Comprehensive paid medical and parental leave</span></strong><span data-contrast="none"> to care for yourself and your family </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <p><strong><span data-contrast="auto">Skill Development & Career Paths:</span></strong><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul></div>