Senior Manager Analytical Operations

What You'll Do

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

·       Review analytical method transfer documentation

·       Review analytical method validation protocols/ reports

·       Review stability protocols and monitor stability program

·       Author, review, and approve analytical technical reports

·       Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings.

·       Collaborate with Quality Assurance to close investigations and deviations

·       Manage reference standards and critical reagents programs, including qualification, re-testing strategies, and bridging activities across CDMOs

·       Direct batch release support by reviewing and approving sampling plans and analytical data; generate and maintain CoAs, CoTs, and product specifications

·       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 U.S-based remote/hybrid/on-site role that will require as needed visits to our San Francisco Office.

Who You Are

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.