Manager, Quality Control

About Calcilytix & BridgeBio Pharma

Calcilytix Therapeutics, an affiliate of BridgeBio Pharma, is developing encaleret (CLTX-305), 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 and Fast Track Designations from the US FDA.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at https://calcilytix.com/ | https://bridgebio.com

Who You Are

The Quality Control Manager at Eidos/Bridge Bio will be an important part of our Quality Control group supporting our late-stage small molecule acoramidis program as well as other BridgeBio subsidiaries. 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 (discriminating and USP), 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 Eidos regulatory submissions (both DS and DP). Excellent communication skills (both verbal and written) a must.

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 method validation and method transfer activities
• Travel, when necessary, to analytical testing sites
• Able to communicate results both internally and externally through oral and written updates and formal reports as necessary
• Create or review Eidos Standard Operating Procedures as it pertains to Quality Control or management of contract analytical laboratories

No matter your role at BridgeBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quali