Scientist I

Role: Support ADC drug substance manufacturing, focusing on tech transfer, process characterization, and optimization. Responsibilities: oversee person-in-plant support, batch record review, deviation impact assessments, change controls, validation documentation, and serve as SME for manufacturing equipment. Conduct experimental work for process development, interpret results, and draft validation and change control documents. Ensure compliance with GxP and safety standards. Qualifications: Bachelor's degree with ~5 years or Master's with ~2 years in chemistry, chemical engineering, biology, or related fields; practical lab or manufacturing experience preferred. High-Value: ADC biologics, late-phase process characterization, manufacturing support, GxP compliance, hands-on experience with chromatography, UFDF, and analytical tools like HPLCs. Collaboration: cross-functional within manufacturing and quality teams. Work setup: role involves site support at Worcester and Waltham, MA, with occasional travel.