Analytical Development - Manager / Sr. Manager

📋 Description

• 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

🎯 Requirements

• 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

🎁 Benefits

• Market-leading compensation
• 401(k) with employer match
• Employee Stock Purchase Program (ESPP)
• Fertility & family-forming benefits
• Hybrid work model
• Comprehensive paid medical and parental leave