Associate Director, Analytical Development

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

Calcilytix seeks a motivated, knowledgeable, and hands-on small molecule analytical development professional to contribute to the late-phase clinical development of CLTX-305 (Encaleret) and NDA submission.  The position requires close collaboration with the Drug Substance, Drug Product, and Quality Assurance groups.  The candidate should know the various analytical techniques (e.g., HPLC, GC, GC/MS, LC/MS, ICP, dissolution, Karl Fischer, NMR, XRPD, DSC, and TGA) and have an in-depth knowledge of one or more techniques.  In addition, this individual should be experienced in test method development, analytical method transfer, and phase-appropriate method validation for both drug substances and products.  A thorough understanding of relevant ICH quality guidelines and excellent communication skills (both verbal and written) is required.  Experience managing outsourced analytical activities at contract manufacturing sites and testing laboratories is required. 

• Management of contract drug substance and drug product analytical development activities and timelines
• Review analytical method transfer documentation 
• Review analytical method validation protocols/ reports
• Review stability protocols and monitor the stability program 
• Author, review, and approve analytical and technical reports 
• Author, review, and adjudicate relevant CMC sections for U.S. and ex-US regulatory filings
• Collaborate with Quality Assurance to close investigations and deviations
• Manage reference standard materials

• 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-quality executors, who execute against goals and milestones with quality, precision, and speed

• Ph. D./M.S. in life sciences, ideally Analytical Chemistry, Chemistry, or Pharmacological Chemistry preferred; someone with a B.S. will be considered with additional five years of industrial experience
• 10 years of experience in analytical development in a pharmaceutical setting; 15 years non-Ph.D. will be considered
• Expertise and/or familiarity with the current analytical techniques for pharmaceutical development 
• Experience developing drug product tests and supporting formulation development
• Experience supporting process development and validation
• Knowledge and direct experience with CMC analytical requirements for IND/IMPD and NDA/MAA filing 
• Ability to communicate effectively with vendors and external partners regarding project scope, scientific results, and project updates 
• Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices 
• Strong oral and written communication skills 
• Proven abilities in leadership
• Ability to accommodate as much as 10% of travel

• 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. Learn more about how we do this here
• 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

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Salary : $152,000 - $195,000