Head of Drug Product Analytical Operations

Essential Functions Lead and develop the Analytical Drug Product team. Oversee outsourced analytical development at CROs/CDMOs (phase-appropriate strategy, quality, governance, alignment). Build external partnerships; review technical documents; manage escalation and lifecycle changes. Lead analytical strategy for drug products, medical devices, and combination products (methods, characterization, stability, extractables/leachables; peptide-specific support). Oversee impurity, degradation, release, stability, comparability, and compatibility assessments. Partner with CMC/product teams for development, global regulatory submissions, clinical bulk supply release/stability, and lifecycle plans; ensure stability programs meet global expectations. Prepare/review analytical content for global regulatory submissions; serve as analytical lead for health authority interactions; lead responses to agency questions, inspections, and audits. Oversee analytical evaluation of primary/secondary packaging (integrity, E&L, compatibility) and integrate packaging studies into stability/lifecycle. Lead cross-functional governance/technical transfer/issue resolution and risk-based decisions across internal and external sites. Manage analytical budgets and external spending/cost optimization. Lead multiple analytical activities; prioritize, mitigate risks, troubleshoot/investigate, and communicate recommendations. Requirements Ph.D. (Analytical Chemistry/Pharmaceutical Sciences/Chemistry or related) with 10+ years pharma/biotech experience OR Master’s with 15+ years. Extensive experience with combination products (injectable support; packaging; lifecycle; Phase 3; process validation; launch readiness; commercial transfer). Experience with injectable synthetic peptide characterization (orthogonal methods, bioassays, solid-state, stability; phase-appropriate strategies). Proven management of outsourced analytical programs with global CROs/CDMOs. Deep knowledge of method development/qualification/validation/transfer, comparability, and regulatory submissions for drug products/devices/combination products. Packaging assessment expertise (E&L, compatibility). Familiarity with ICH, FDA, EMA, JP, and relevant ISO standards. Skills Strong project management/organization; problem-solving; communication/collaboration; data analysis and translating findings into technical/regulatory/business recommendations. Benefits Eligible for Restricted Stock Units; bonus or sales incentive; company-sponsored 401(k) match; medical/dental/vision/prescription coverage; wellness stipends; generous vacation/holiday schedule. #J-18808-Ljbffr Scorpion Therapeutics