CMC Project Manager
Core
Manage the planning, development, and execution of projects supporting tissue product process development and medical device integration programs.
Role type
Senior CMC Project Manager (Technology Transfer)
Builds
Tissue products and medical device pipelines through manufacturing and regulatory transfer
Domain
Regenerative biologics, advanced wound care, surgical products
Required skills
Project management, cGMP compliance, root cause analysis, statistical trending, technical writing, regulatory document preparation, cross-functional collaboration, quality control planning, data analysis
Preferred skills
PMP certification
Technologies
MS Project, Minitab, MS Excel, MS Word
Responsibilities
Manage project timelines and functional deliverables for tissue product and medical device development; Collaborate with cross-functional teams on biologic manufacturing processes and product characterization; Review and execute protocols per regulatory requirements; Perform technical analysis including root cause analysis and predictive statistics; Author and review regulatory documents for FDA and other authorities; Plan and execute characterization studies for commercial supply chain
Seniority
Senior, hands-on IC with management scope
