Senior Manager, CMC Analytical Development

Confirmed live in the last 24 hours

BridgeBio Pharma

Remote - USA

On-site

Posted March 11, 2026

Job Description

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
 
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 
 
Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

Who You Are

The Senior Manager of Analytical Development will join the Analytical Development Team within Chemistry and Manufacturing and Controls (CMC) and report to a Director of Analytical Development. This role will work closely with the entire CMC team to execute late-stage development activities in support of Phase III clinical trials through commercial activities. Candidates for this position will be required to work independently and have experience managing outsourced analytical activities at contract manufacturing sites and testing labs.

Where You'll Work

This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Responsibilities

_Oversee contract development and manufacturing organizations (CDMOs) to manage analytical development and quality control (QC) activities for drug substance (DS) and product (DP)

Manage analytical documentation (i.e., CofAs, test methods, protocols, reports, specifications, stability, and raw data) within Quality Management System (QMS)
Support and author analytical content for CMC Regulatory content for U.S. and Rest of World dossiers
Manage GMP stability studies and provide trend analysis in support of retest and shelf-life extension
Manage reference standard program (i.e., qualification, storage, inventory, distribution)
Development and approval of specifications for raw materials, intermediates, and finished product and knowledge of regulatory requirements in the setting of specifications
Development and validation of analytical methods and verification of compendial methods
Able to communicate results both internally and externally through oral and written updates and formal reports as necessary
Provide analytical support for API and Drug Product process development
Authoring of development reports, protocols, and methods
Support quality audits as a technical representative and contribute to authoring of audit reports