Senior Scientist, Engineering II

Role: Lead late-stage development, scale-up, validation, and commercialization of oral solid dosage products, ensuring robust manufacturing processes and regulatory compliance. Responsibilities: manage scale-up from pilot to commercial manufacturing, develop and execute technology transfer strategies, apply experimental design and modeling for process development, establish process control strategies, lead process validation and PPQ activities, author regulatory CMC documentation, and collaborate with cross-functional teams including Manufacturing, Quality, and Regulatory Affairs. Qualifications: Bachelor's degree with ~12 years, Master's with ~10 years, or PhD with ~4 years of relevant experience in pharmaceutical process engineering, especially in oral solid dosage form development and commercialization. Skills include process scale-up, process characterization, validation principles, DoE, QbD, risk assessment, and regulatory documentation. High-Value: Expertise in oral solid dosage manufacturing, process validation, process transfer, and regulatory submissions (e.g., CTD). Experience in scaling processes from laboratory to commercial levels and leading cross-site technology transfer is essential. Work setup and travel details are not specified.