Quality Control Manager

Summary

Join Calcilytix Therapeutics, a BridgeBio Pharma affiliate, as their Quality Control Manager. You will play a vital role in ensuring cGMP compliance at contract manufacturing organizations (CMOs) for the late-stage acoramidis program and other BridgeBio subsidiaries. A significant portion of your responsibilities will involve critically reviewing analytical test packages for release, in-process, and stability testing. You will collaborate closely with QA and CMOs, requiring expertise in various analytical techniques and ICH guidelines. The position demands strong communication, leadership, and organizational skills. BridgeBio offers a competitive compensation and benefits package, including flexible PTO, opportunities for career advancement, and a collaborative work environment.

Requirements

• 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)
• 2+ years management experience
• Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates
• Proven abilities in leadership and personnel management
• Strong oral and written communication skills
• Excellent organizational and planning skills and high attention to detail
• Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines
• Sophisticated understanding how and when to appropriately apply the cGMP requirements; ability to distinguish regulated and non-regulated activities

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

Preferred Qualifications

• 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
• A thorough and sophisticated understanding of relevant ICH guidelines and health authority expectations

Benefits

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• An unyielding commitment to always putting patients first
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion