Teams at Crescent Biopharma, Inc.

Lead QC operations for biologics across CDMOs and CTLs, managing stability, specifications, reference standards, method transfers, validation, data integrity, regulatory Module 3 support, OOS/OOT/CAPA oversight, and mentoring QC staff to ensure GMP and ICH compliance throughout product lifecycle.

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.

Lead high-volume contract lifecycle for biotech agreements (CDAs, MSAs, SOWs, CTAs, vendor/supply and consulting agreements), draft/redline, manage negotiations, maintain CLM (LinkSquares), enforce governance, support audits/diligence, mitigate legal/IP/privacy/regulatory risks, and improve contract processes across cross-functional teams.