Director - BRD Analytical Development

Role: Lead analytical scientist specializing in pharmaceutical drug substance and/or drug product development, focusing on enabling clinical trials, regulatory submissions, and commercialization. Responsibilities: develop and qualify analytical methods, justify specifications, design stability studies, author regulatory documents (IND/CTA, BLA/NDA/MAA), and provide technical guidance for external transfer and collaborations with CROs/CMOs. Drive technical solutions to support process design, ensure robust control strategies, and lead cross-functional teams. Requirements: Ph.D. in Analytical/Bioanalytical Chemistry with 5+ years in pharma, or B.S. with 15+ years, with experience leading analytical efforts in pharmaceutical development; familiarity with regulatory filings and emerging industry trends; strong communication, organizational, leadership, and mentorship skills. HighValue: expertise in peptide, oligonucleotide, monoclonal antibody, gene therapy modalities; experience with global regulatory strategies and submissions; experience with technology transfer and external network guidance. WorkSetup: onsite Indianapolis, IN; travel 0-15%.