New Engineer/Scientist, Drug Product Process Development and Manufacturing

This is a builder role that is ideal for someone with deep technical know-how and a bias toward action. You’ll work cross-functionally to develop scalable formulations, drive process optimization, manage CDMO relationships, and ensure successful tech transfers and validation - all in service of getting life-changing therapies to patients faster. Primary responsibilities include designing and optimizing robust oral solid dosage formulations for clinical and commercial development. You will lead tech transfer activities from development to external manufacturing, ensuring seamless scale-up and validation. Additionally, you’ll author and review key technical documentation including batch records, master manufacturing records, and process validation protocols. A key part of the role is to investigate and resolve deviations and batch failures in collaboration with QA, Regulatory, and CDMO partners. You will serve as the technical point of contact for CDMO selection, oversight, and performance management. Drive process improvements using QbD and risk-based approaches to meet quality, regulatory, and timeline expectations, and collaborate with cross-functional teams to ensure end-to-end alignment.