Responsibilities

As a Director CMC Operations, the individual will serve on interdisciplinary client project teams, providing technical leadership and guidance in process development and manufacturing, collaborating with colleagues to develop strategies and workflows, leading the identification and selection of CRO and CDMO partners, managing those relationships, conducting due diligence, performing market assessments, leading internal meetings, drafting CMC sections of regulatory submissions, recognizing and mitigating risk, and participating in investigations of manufactured product. Additionally, the role involves managing consulting groups to ensure successful project execution and staff development.