- Location
- Remote - USA
- Workplace
- Remote
- Department
- Manufacturing
- Seniority
- Director
- Education
- PhD
- Source
- Greenhouse
Description
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.
What You'll Do
The Associate Director, Process Chemistry will be responsible for supporting drug substance related activities, both externally and internally. They will interface directly with CROs, CDMOs and others to execute on-time delivery and ensure phase appropriate process procedures are followed. Internally, they will interface with both CMC and members of other departments to effectively execute their drug substance project needs.
Responsibilities
- Oversee contract development and manufacturing organizations (CDMOs) to Process Chemistry activities for drug substance (DS) with a focus on late stage and validation, working across both International and US based CDMO’s. Additionally, provide on-site technical support at CDMO’s on an as-needed basis to oversee various manufacturing/scale-up/validation activities and provide technical expertise to troubleshoot manufacturing/packaging process issues
- Author and manage request for proposal documents to initiate work at CDMO’s
- Support and author DS content for CMC Regulatory for US and Rest of World with focus on late-stage development and marketing applications
- Support Quality Assurance audits, on site at CDMO’s or remotely, as a technical subject matter expert, as needed
- Proactively interface effectively with other CMC team members (e.g., Analytical Chemistry, Formulation Development, Quality Assurance, Supply Chain, etc.)
- Regularly and clearly communicate Process Chemistry both verbally and in visual presentation form, efficiently and contextually
Where You'll Work
This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco Office.
Who You Are
- PhD. in Organic Chemistry from Purdue University
- 7+ years as a process chemist in industry
- Experience leading route scouting, process development, scale-up, DOE, process validation, and CMC strategies for small molecule drug substances
- Additional experience with authoring and reviewing regulatory documents, including INDs, NDAs, MAAs, CBE30, and Type II submissions.
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 BridgeBio Full-Time U.S Based Roles:
Financial & Rewards
- Market-leading compensation
- 401(k) with employer match
- Employee Stock Purchase Program (ESPP)
- Pre-tax commuter benefits (transit and parking)
- Referral bonus for hired candidates
- Subsidized lunch and parking on in-office days
Health & Well-Being
- 100% employer-paid medical, dental, and vision premiums for you and your dependents
- Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
- Fertility & family-forming benefits
- Expanded mental health support (therapy and coaching resources)
- Hybrid work model with flexibility
- Flexible, “take-what-you-need” paid time off and company-paid holidays
- Comprehensive paid medical and parental leave to care for yourself and your family
Skill Development & Career Paths:
- 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
- We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
- We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
By applying, you acknowledge that BridgeBio will process your personal information as described in our Global Candidate Privacy Notice.