Sr. Manager / Associate Director, Drug Substance; Hypopara at BridgeBio

San Francisco - 1800 OwensFull-timeManufacturingPosted 15 days ago

About the Role

<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>What You'll Do</h3>   Senior Scientist / Associate Director, Drug Substance Development and Manufacturing will support Calcilytix Therapeutics, a subsidiary of BridgeBio Pharma. This position will be responsible for managing outsourced drug substance process development and manufacturing activities at contract suppliers, including manufacture of raw materials and drug substance for clinical studies, process validation, commercial launch, and tech transfer to new vendors to build and maintain the commercial supply chain throughout product lifecycle. The position will also support submission of global marketing authorization applications and responses to health agency queries.   <h3>Responsibilities</h3>   <ul> <li> Manage multiple CMOs and CROs to deliver bulk starting materials, intermediates, and drug substance of sufficient quality and quantity to meet corporate and regulatory requirements. Maintain in-depth knowledge of chemical steps, manufacturing processes, and quality controls. </li> <li> Establish and maintain business relationships with CROs and CMOs appropriate for performing process validation and commercial supply requirements. </li> <li> Lead early to mid-stage process development and manufacturing to support clinical studies. </li> <li> Lead validation and commercial-scale manufacturing. </li> <li> Identify and lead key process problem resolution activities and process improvement initiatives. </li> <li> Work closely with Quality Assurance function to develop and operate appropriate cGMP procedures, and to ensure product meets established quality standards. </li> <li> Create and disseminate technical transfer information required by CROs and CMOs to develop and scale up chemical processes and develop and validate analytical methods. </li> <li> Support authorship, review, and response to queries on all Module 3 drug substance development sections of CTD. Contribute to the overall regulatory control strategy. </li> <li> Support a culture of continuous improvement and high-performance teamwork. </li> </ul>   <h3>Where You'll Work</h3>   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.   <h3>Who You Are</h3>   <ul> <li> Minimum of PhD (ideally chemistry or chemical engineering) with 7+ years relevant experience, or BS/MS with 10+ years relevant experience. </li> <li> Demonstrated chemical development at industrial scale. </li> <li> Demonstrated experience in managing drug substance chemical development, process validation and manufacturing in support of marketing applications and commercial production. </li> <li> Strong aptitude and demonstrated experience in synthetic organic chemistry. </li> <li> Working knowledge of analytical method development and validation. </li> <li> Familiarity with FDA and ICH guidelines for INDs/NDAs/MAAs. Thorough understanding of cGMP, quality and regulatory requirements for drug substance manufacturing. </li> <li> Ability to effectively interface with and/or manage highly skilled internal staff. </li> <li> Ability to work independently as well as in a team. Ability to build good work relationships. Strong attention to detail and time management skills. Excellent oral and written communication skills. </li> <li> Up to 20% travel may be required. </li> </ul>   <h3>Rewarding Those Who Make the Mission Possible</h3>   We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.    Financial Benefits:   <ul> <li> Market leading compensation  </li> <li> 401K with 100% employer match on first 3% & 50% on the next 2% </li> <li> Employee stock purchase program </li> <li> Pre-tax commuter benefits </li> <li> Referral program with $2,500 award for hired referrals </li> </ul>   Health & Wellbeing:   <ul> <li> Comprehensive health care with 100% premiums covered - no cost to you and dependents </li> <li> Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions) </li> <li> Hybrid work model - employees have the autonomy in where and how they do their work  </li> <li> Unlimited flexible paid time off - take the time that you need </li> <li> Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents </li> <li> Flex spending accounts & company-provided group term life & disability  </li> <li> Subsidized lunch via Forkable on days worked from our office </li> </ul>   Skill Development & Career Paths:   <ul> <li> 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 </li> <li> We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching </li> <li> We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities </li> </ul><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">$175,000—$185,000 USD</div></div></div><div class="content-conclusion">As a global company, our comprehensive benefits may vary based on location.  We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. For USA based roles: Financial & Rewards   <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">Market-leading compensation   </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">401(k) with employer match   </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">Employee Stock Purchase Program (ESPP)  </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">Pre-tax commuter benefits (transit and parking)  </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">Referral bonus for hired candidates  </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">Subsidized lunch and parking on in-office days  </li> </ul> Health & Well-Being   <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">100% employer-paid medical, dental, and vision premiums for you and your dependents  </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">Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)  </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">Fertility & family-forming benefits  </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"> Expanded mental health support (therapy and coaching resources)  </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">Hybrid work model with flexibility  </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">Flexible, “take-what-you-need” paid time off and company-paid holidays  </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">Comprehensive paid medical and parental leave to care for yourself and your family  </li> </ul> Skill Development & Career Paths:  <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">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 </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">We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching </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">We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities </li> </ul></div>

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