What You'll DoResponsible for managing the development and tracking of stage-appropriate testing methodology for drug substance and drug product, including in-process, release, stability, method validation and site transfer under aggressive timelines. Communicate and coordinate with internal Analytical, CMC, QA, Regulatory, Project Management and consultants, as well as with external CROs/CMOs counterparts. Manage critical analytical review of SOPs, test methods and specifications for raw materials/intermediates/drug substance/drug product, development/verification reports, validation protocols/reports, method transfers, COAs and stability summaries. Support contractor site investigations pertaining to OOS/OOT and deviations.
ResponsibilitiesSupport Analytical (CMC) activities associated with the formulation of infigratinib.
Work closely with your Analytical Development colleagues and external CROs/CMOs collaborators to rapidly advance programs to key decision points, in preparation of regulatory submission, approval and post-approval commitments.
Assist in data generation and analysis.
Ensure analytical development activities are aligned with the project's overall objectives.
Assist in regulatory filings.
Perform data review & stability tracking.
Where You'll WorkRemote with 30% travel anticipated
Who You AreMS in Organic Chemistry, Analytical Chemistry, Pharmaceutical Science.
5+ years' experience in the contract research or pharmaceutical/biotech industry.
Demonstrated abilities in the development and application of analytical assay, impurity, and in-vitro (dissolution) release.
Experience in high performance liquid chromatography and physicochemical properties (solubility, solid state, physical testing), methods development, drug substance and drug product
Knowledge of cGMP regulations, including compendial (USP, EP, JP) and guidance documents.
Working knowledge of FDA, EMA and ICH guidelines.
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
$144,000-$159,000 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
