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 promising early‑stage research from academia under one financial umbrella to reduce risk and unleash innovation. This model lets science and small teams of experts lead the way, building bridges to groundbreaking advancements in rare disease and developing life‑changing medicines for patients with unmet needs as fast as possible.
We define white space, push boundaries, and empower people to solve problems. If you defy convention, work alongside some of the most respected minds in the industry and help re‑engineer the future of biopharma.
What You’ll DoSenior 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 technology 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.
Responsibilities- 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.
- Establish and maintain business relationships with CROs and CMOs appropriate for performing process validation and commercial supply requirements.
- Lead early to mid‑stage process development and manufacturing to support clinical studies.
- Lead validation and commercial‑scale manufacturing.
- Identify and lead key process problem resolution activities and process improvement initiatives.
- Work closely with the Quality Assurance function to develop and operate appropriate cGMP procedures, ensuring product meets established quality standards.
- Create and disseminate technical transfer information required by CROs and CMOs to develop and scale up chemical processes and develop and validate analytical methods.
- Support authorship, review, and response to queries on all Module 3 drug substance development sections of the CTD, contributing to the overall regulatory control strategy.
- Support a culture of continuous improvement and high‑performance teamwork.
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.
Who You Are- Minimum of PhD (ideally chemistry or chemical engineering) with 7+ years relevant experience, or BS/MS with 10+ years relevant experience.
- Demonstrated chemical development at industrial scale.
- Experience in managing drug substance chemical development, process validation, and manufacturing in support of marketing applications and commercial production.
- Strong aptitude and demonstrated experience in synthetic organic chemistry.
- Working knowledge of analytical method development and validation.
- Familiarity with FDA and ICH guidelines for INDs/NDAs/MAAs. Thorough understanding of cGMP, quality and regulatory requirements for drug substance manufacturing.
- Ability to effectively interface with and/or manage highly skilled internal staff.
- Ability to work independently as well as in a team, build good work relationships, and maintain strong attention to detail and time management skills.
- Excellent oral and written communication skills.
- Up to 20% travel may be required.
- Market‑leading compensation
- 401(k) with 100% employer match on the first 3% and 50% on the next 2%
- Employee Stock Purchase Program
- Referral program with $2,500 award for hired referrals
- Comprehensive health care with 100% premiums covered – no cost to you and dependents
- Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- Hybrid work model – employees have the autonomy in where and how they do their work
- Unlimited flexible paid time off – take the time that you need
- Paid parental leave – 4 months for birthing parents & 2 months for non‑birthing parents
- Flex spending accounts & company‑provided group term life & disability
- Subsidized lunch via Forkable on days worked from our office
$175,000 – $185,000 USD (California – final offer will depend on experience, education, location, and interview performance).
Equal Opportunity Employer StatementBridgeBio is an equal opportunity employer and embraces a diverse workforce. Hiring decisions are made without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic.
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