Senior Director, Analytical Development

Summary

Join BridgeBio as a Sr. Director/Executive Director, Analytical Development to lead analytical development and commercial quality control groups supporting late-stage novel small molecule development programs. You will author and revise analytical development sections of regulatory submissions, contribute to CMC regulatory strategy, and manage external CDMOs. Responsibilities include oversight of late development/launch preparation activities, method transfers, and validation. Close collaboration with drug substance and formulation scientists and Quality Assurance is required. A comprehensive understanding of ICH guidelines and health authority expectations is essential. BridgeBio offers a competitive compensation and benefits package, flexible PTO, and opportunities for rapid career advancement.

Requirements

• Ph.D./M.S. in life sciences, ideally Chemistry or Analytical Chemistry, with 10+ years of experience in analytical development in a pharmaceutical setting.  B.S. will be considered with/an additional 5 years of industrial experience
• Proven abilities in leadership and personnel management
• Knowledge and direct experience with CMC analytical requirements for IND and NDA/MAA filing
• Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates
• Strong oral and written communication skills

Responsibilities

• Proven leadership experience in managing analytical chemists at various levels, externally (CRO/CMO management) and internally (direct report management)
• Experience writing, reviewing, and responding to queries on all Module 3 analytical sections of BridgeBio Cardiorenal CTDs.  Expected to contribute to the overall control strategy for all regulatory filings (incl. DS and DP)
• Management of direct reports
• Sophisticated understanding of how and when to appropriately apply the cGMP requirements; ability to distinguish regulated and non-regulated activities and expectations
• Travel, when necessary, to third-party manufacturing and/or testing sites
• Oversight of third-party development of analytical methods, method validation, and investigations for out-of-specification, out-of-trend, and/or anomalous results
• Collaboratively plan and execute cross-functional studies for chemical development and formulation development
• Proficiency in various analytical techniques and regulatory areas, including HPLC, LC/MS, GC, GC/MS, USP dissolution testing apparatus, pH meters, UV/Vis spectroscopy, KF, and phase-appropriate analytical method validation
• Responsible for developing phase-appropriate qualifications and/or validating requisite analytical methods.  The ideal candidate will be familiar with current statistical techniques used in method development and validation
• Able to communicate results internally and externally through verbal and written updates and formal reports as necessary

Preferred Qualifications

• Candidates with prior NDA/MAA authoring experience will be preferred
• Prior NCE filing experience is a plus
• Experience with various solid-state characterization techniques, including XRPD, PSD measurement, DSC, and TGA, as well as familiarity with drug product (disintegration, hardness, and friability) testing, is also desired

Benefits

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• An unyielding commitment to always putting patients first
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion