Teams at Crescent Biopharma, Inc.

Lead cross-functional CMC project management for clinical-stage oncology programs: create and maintain integrated plans, manage timelines, risks, vendors (CDMOs/CROs), support CMC regulatory submissions, track budgets and resources, and implement process improvements to ensure delivery of CMC milestones.

Provide high-level administrative support to R&D and medical C-suite leaders: manage complex calendars, travel, meeting coordination, document preparation, confidential records, cross-functional liaison work, and operational support for clinical and regulatory workflows.

Provide strategic and hands-on GMP QA leadership for biologics manufacturing across outsourced CDMOs, including batch review and release, tech transfer, PPQ, audits, issue/CAPA management, regulatory submission support, eQMS implementation, and mentoring QA staff to ensure clinical supply and commercial readiness.