Sr. Manager, Analytical Development

About the Role

BridgeBio seeks a motivated, knowledgeable, and hands-on analytical development scientist and quality control professional to manage analytical development, QC, and stability activities at contract manufacturing sites and to contribute to the development of clinical assets and regulatory submissions. This position requires close collaboration with the Drug Substance, Drug Product, and Quality Assurance groups. This candidate should know the various analytical techniques across modalities. In addition, this individual should be experienced in test method development, analytical method transfer, phase-appropriate method validation, and stability program management (including data trending and analysis) for both drug substances and drug products. A thorough understanding of relevant ICH quality guidelines and excellent communication skills (both verbal and written) is required.

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.

Qualifications

• 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

Pay

Salary $175,000 - $185,000 USD

Benefits

• Financial & Rewards: Market-leading compensation; 401(k) with employer match; Employee Stock Purchase Plan (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