Analytical Manager, Quality Control

Eidos Therapeutics, a subsidiary of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our product candidate, AG10, is an orally-administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country. 

To learn more, visit us at  eidostx.com/ www.bridgebio.com

Who You Are:

Eidos is seeking a Manager in our commercial Quality Control group supporting our late-stage small molecule acoramidis program.  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 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
• Oversight of laboratories including investigations for out of specification, out of trend, 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

Education, Experience & Skills 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)
• 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 
• Proficiency in a variety of analytical techniques and regulatory areas including, but not limited to: HPLC, LC/MS, GC, GC/MS, USP dissolution testing apparatus, pH meters, UV/Vis spectroscopy, KF, disintegration, DSC, TGA, hardness, and friability and phase appropriate analytical method validation
• 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 of how and when to appropriately apply the cGMP requirements; ability to distinguish regulated and non-regulated activities

What We Offer:

• Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
• Learning and development training to help employees be the best version of themselves
• Collaborative business environment
• Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
• Excellent benefits package
• Flexible PTO
• With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
• A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
• Work with the most productive groups of R&D operators in the industry
• Partnerships with leading institutions
• A platform for meaningful scientific contributions to shine
• Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so

We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.