Note: The job is a remote job and is open to candidates in USA. BridgeBio is a biopharmaceutical company focused on developing life-changing medicines for patients with unmet needs, particularly in rare disease. The Director, Analytical Development will manage analytical testing methodologies for drug substance and drug product, coordinate with internal and external partners, support formulation and regulatory activities, and oversee data review and stability tracking.
Responsibilities
- Responsible 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
- Support 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
Skills
- MS 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
- Remote with 30% travel anticipated
Benefits
- Annual performance bonus
- Company equity
- Generous health benefits
- 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
- 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
- Endless opportunities for skill development and internal mobility
- Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
- Financial rewards, peer-to-peer recognition, and growth opportunities
Company Overview
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