Sr. Director/Executive Director, Analytical Development @BridgeBio Pharma

[Hiring] Sr. Director/Executive Director, Analytical Development @BridgeBio Pharma

Apr 03, 2025 - BridgeBio Pharma is hiring a remote Sr. Director/Executive Director, Analytical Development. 💸 Salary: $230,000 - $290,000 usd. 📍Location: USA.

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Role Description

BridgeBio seeks a Sr. Director/Executive Director, Analytical Development to lead our analytical development (AD) and commercial quality control (QC) groups supporting our late-stage novel small molecule development programs.

Responsible for authoring and revising analytical development (AD) sections of regulatory submissions (e.g., IND, IMPD, NDA, MAA, etc.)
Input on CMC regulatory strategy for both drug substance (DS) and drug product (DP) across the BridgeBio cardiorenal small molecule portfolio
Oversight of late development/launch preparation activities, including analytical method transfers, method development, phase-appropriate validation for both DS and DP
Review of analytical packages for the release of clinical/commercial supplies
Close collaboration with drug substance and formulation scientists and Quality Assurance
Working knowledge of GMPs and various small molecule analytical techniques

Qualifications

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
Strong oral and written communication skills

Requirements

Proven leadership experience in managing analytical chemists at various levels
Experience writing, reviewing, and responding to queries on all Module 3 analytical sections of BridgeBio Cardiorenal CTDs
Management of direct reports
Sophisticated understanding of cGMP requirements
Travel to third-party manufacturing and/or testing sites when necessary
Oversight of third-party development of analytical methods and method validation
Collaboratively plan and execute cross-functional studies for chemical development and formulation development
Proficiency in various analytical techniques and regulatory areas
Experience with various solid-state characterization techniques
Responsible for developing phase-appropriate qualifications and/or validating requisite analytical methods
Able to communicate results internally and externally through verbal and written updates and formal reports

Benefits

Patient Days to hear directly from individuals living with the conditions we are seeking to impact
A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
A de-centralized model that enables program teams to focus on advancing science and helping patients
A collaborative, fast-paced, data-driven environment
Access to learning and development resources
Robust and market-competitive compensation & benefits package
Flexible PTO
Rapid career advancement for strong performers
Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas
Partnerships with leading institutions
Commitment to Diversity, Equity & Inclusion

Salary

$230,000 — $290,000 USD

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Sr. Director/Executive Director, Analytical Development @BridgeBio Pharma

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Salary 💸 $230,000 - $290,000 usd	Remote Location USA
Job Type unspecified	Posted Apr 03, 2025

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[Hiring] Sr. Director/Executive Director, Analytical Development @BridgeBio Pharma

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