Principal Engineer, Process Development - OSD

Role: Principal Engineer leading late-stage small molecule drug product process development from Phase 3 to PPQ, focusing on scale-up and technical transfer. Responsibilities: provide technical guidance, design experiments, develop process control strategies, and oversee external manufacturing collaborations; prepare regulatory documentation and present data to stakeholders; identify new technologies; mentor junior staff; support critical manufacturing activities onsite. Requirements: PhD (>8 years) or MS (>15 years) in Science or Engineering with expertise in small molecule process development, scale-up, and transfer; strong knowledge of ICH, FDA, USP regulations; adept in processing techniques such as granulation, coating, compression; experience managing CDMOs; excellent communication and leadership skills. Preferred: Process Analytical Technology experience. High-value: small molecules, late-stage development, regulatory compliance, cross-functional collaboration, travel required for manufacturing site support.