Responsibilities
Management of contract drug substance and drug product analytical development and quality control activities and timelines
Authoring and review of analytical method transfer and validation protocols and reports
Direct batch release support by reviewing and approving sampling plans and analytical data; generate and maintain CoAs, CoTs, and product specifications
Review stability protocols and monitor various stability programs
Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings
Partner with QA to manage change controls; lead OOS/OOT and deviation investigations to identify root causes and implement CAPAs
Develop, revise, and approve SOPs and QC processes, enhancing compliance, consistency, and operational efficiency
Where You'll Work
This is a hybrid role and requires in-office collaboration 2x per week in our San Francisco office.
Who You Are
At least 10 years of experience in Analytical Development and/or Quality Control in a pharmaceutical setting.
Familiarity with CMC analytical regulatory requirements and authoring of IND/IMPD/BLA/NDA/MAA filings and responses to regulatory inquiries
Independently proficient in a variety of analytical techniques in support of biologic and small molecule development.
Ability to communicate effectively with vendors regarding project scope, scientific results and project updates. Ability to understand project timelines and appropriately prioritize activities to achieve project goals.
Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices.
Subject matter expertise in stability program management, including protocol design, data trending and analysis (e.g., using JMP), and shelf-life assignment/extension.
Proficient with enterprise quality management systems such as Veeva Vault, TrackWise, and LIMS.
The position will require an ability to adapt to changes in priorities on short notice and will also require an ability to make decisions, independently, under tight timelines.
Position requires 5-15% travel. Must have the ability to travel internationally.
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.
Salary
$153,000—$185,000 USD
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.
