Manager, Analytical Development

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $144k - $159k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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BridgeBio

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2015

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

BridgeBio is a biotechnology company focused on designing transformative medicines for patients with genetic diseases. It employs a novel approach to drug development by integrating finance with science to deliver solutions as efficiently as possible. The company is committed to developing not only life-changing drugs but also leaders in the field, encouraging hands-on engagement and the pursuit of innovation. BridgeBio actively seeks investment to help achieve its mission of providing solutions for unique patient populations with unmet needs. Headquartered in Palo Alto, CA, BridgeBio emphasizes bridging the gap between scientific advancements and patient care.

📋 Description

• Manage 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 • Coordinate with internal Analytical, CMC, QA, Regulatory, Project Management, and consultant teams, as well as external CRO/CMO counterparts • Review SOPs, test methods, specifications, development/verification reports, validation protocols/reports, method transfers, COAs, and stability summaries • Support contractor site investigations involving OOS/OOT and deviations • Support Analytical CMC activities for the formulation of infigratinib • Collaborate with Analytical Development colleagues and external CROs/CMOs to advance programs toward regulatory submission, approval, and post-approval commitments • Assist in data generation and analysis • Align analytical development activities with overall project objectives • Assist in regulatory filings • Perform data review and stability tracking

🎯 Requirements

• MS in Organic Chemistry, Analytical Chemistry, or Pharmaceutical Science • 5+ years’ experience in the contract research or pharmaceutical/biotech industry • Demonstrated ability in developing and applying analytical, impurity, and in-vitro dissolution release assays • Experience with high-performance liquid chromatography • Knowledge of physicochemical properties, including solubility, solid state, and physical testing • Experience with methods development for drug substance and drug product • Knowledge of cGMP regulations, including USP, EP, and JP compendial standards and guidance documents • Working knowledge of FDA, EMA, and ICH guidelines

🏖️ Benefits

• Market-leading compensation • Annual performance bonus • Company equity • 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 • 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 • Skill development and internal mobility opportunities • 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