[Hiring] Director, Analytical Development @BridgeBio Pharma

Role Description

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.

Responsibilities

• 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.

Qualifications

• 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.

Benefits

• 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.
• 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.
• 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.