Manager, Quality Control

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.

Calcilytix Therapeutics, an affiliate within Bridge Bio Pharma, is developing encaleret, a negative allosteric modulator of the calcium‑sensing receptor (CaSR) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1), a genetic cause of hypoparathyroidism. Encaleret is currently being evaluated in a Phase 3 clinical study and has received Orphan Drug Designation from the US FDA, EMA, and PMDA as well as Fast Track Designation from the US FDA.

Results from the Phase 2b clinical study of encaleret in patients in ADH1 were published in the .

The Quality Control Manager at Bridge Bio will be an important part of our Quality Control group supporting Bridge Bio subsidiaries (Calcilytix, MLBio, and Eidos). The Quality Control Manager is responsible for ensuring that all activities conducted at the analytical Contract Manufacturing Organizations (CMO) laboratories are conducted in compliance with Current Good Manufacturing Practices (cGMP). A large portion of the position’s responsibilities will be the critical review of analytical test packages for release testing, in‑process testing, and stability testing of clinical/commercial supplies (both DS and DP).

This will involve verification that test methods/procedures are followed as written, and documentation is both complete and accurate. The position will ensure that the data is reviewed in a timely manner. The position requires close collaboration with both Quality Assurance (QA) and the analytical contract laboratories. A working knowledge of various analytical techniques including HPLC, GC, GC/MS, LC/MS, ICP, dissolution, UV, NMR, XRPD, Karl Fischer titration, DSC, TGA, and wet chemistry is required.

A thorough and sophisticated understanding of relevant ICH guidelines and health authority expectations is expected. Additional responsibilities include review of analytical data with respect to late development/launch preparation activities including (but not limited to): analytical method transfer, phase appropriate method validation for both drug substance and drug product methods, and review of data for analytical sections of regulatory submissions (both DS and DP).

Excellent communication skills (both verbal and written) a must.

• 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
• Able to communicate results both internally and externally through oral and written updates and formal reports as necessary
• Create or review BBio Standard Operating Procedures as it pertains to Quality Control or management of contract analytical laboratories

This is a US‑based remote role that will require quarterly, or as needed, visits…