Associate Director, CMC Team Lead

Role: Associate Director, Downstream, Emerging Modalities, leading downstream process development for novel therapeutic modalities, primarily focusing on antibody purification and antibody-oligonucleotide conjugate (AOC) purification. Objectives: enable transition from preclinical to Phase I, designing scalable, phase-appropriate purification processes, and supporting early clinical development. Responsibilities: develop and optimize purification strategies for complex molecules, collaborate with research, analytical, regulatory, and external CDMO partners, author technical documentation for regulatory submissions, and serve as SME in regulatory discussions. Qualifications: advanced degree in life sciences, chemical engineering, or related field; proven experience in CMC and biologics or complex modalities; strong knowledge of emerging modalities like AOCs, POCs, or biologics; excellent cross-functional communication and project management skills. High-Value: expertise in antibody and conjugate purification, process robustness, early-phase CMC development, regulatory CMC activities, and managing external manufacturing partners. Work setup: onsite in Cambridge, MA.