Manager/Sr. Manager, QC

Role Summary

The Quality Control Manager at BridgeBio will be a key member of the Quality Control group, supporting BridgeBio subsidiaries Calcilytix, MLBio, and Eidos. The role ensures that all activities conducted at analytical contract manufacturing organizations (CMOs) laboratories comply with Current Good Manufacturing Practices (cGMP). A large portion of the responsibilities involves the critical review of analytical test packages for release testing, in-process testing, and stability testing of clinical and commercial supplies (drug substance and drug product). This is a U.S.-based remote role with quarterly, or as-needed visits to the San Francisco Office.

Responsibilities

• Review of analytical data for release, stability, and in-process testing at the contract manufacturing organizations in a timely manner.
• Oversight of laboratories including investigations for out of specification, out of trend, deviations, and/or anomalous results.
• Follow up with the contract laboratories to correct any deficiencies/omissions in the provided test packages.
• Submitting test packages to QA for their review and loading all data into the electronic storage program.
• Review of analytical data related to reference standard qualification, method validation and method transfer activities.
• Travel, when necessary, to analytical testing sites or other sites.

Qualifications

• M.S./B.S. in life sciences, ideally Chemistry, Analytical Chemistry preferred.
• 5+ years’ experience in Quality Control in a pharmaceutical setting with solid knowledge of Good Manufacturing Practices (cGMP) and 2+ years management experience.
• Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines with excellent organizational and planning skills and high attention to detail.
• Sophisticated understanding how and when to appropriately apply the cGMP requirements; ability to distinguish regulated and non-regulated activities.
• Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates.

Additional Requirements

• Travel may be required to analytical testing sites or other sites.