Analytical Development - Manager / Sr. Manager at BridgeBio Pharma

Oversee CDMOs to manage analytical development and quality control (QC) activities for drug substance (DS) and product (DP)
Manage analytical documentation (CofAs, test methods, protocols, reports, specifications, stability, and raw data) within Quality Management System (QMS)
Support and author analytical content for CMC Regulatory content for U.S. and Rest of World dossiers
Manage GMP stability studies and provide trend analysis in support of retest and shelf-life extension
Manage reference standard program (i.e., qualification, storage, inventory, distribution)
Development and approval of specifications for raw materials, intermediates, and finished product and knowledge of regulatory requirements in the setting of specifications

At least 7 years of experience in analytical development in a pharmaceutical setting
Proven leadership experience in managing analytical chemists at various levels externally (CMO mgmt.)
Independently proficient in 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, and phase appropriate analytical method validation
Knowledge and direct experience with CMC analytical regulatory requirements and authoring of IND/IMPD filings and response to regulatory inquiries; experience applying regulatory guidelines (ICH, FDA, EMA, etc.) to pharmaceutical development and CMC strategy
Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates. Ability to understand project timelines and appropriately prioritize activities to achieve project goals
The position will require an ability to adapt to changes in priorities on short notice and will also need an ability to make decisions, independently, under tight timelines