CMC Technical Development Leader (TDL):
The key person responsible for accomplishing the supply, timeline and quality goals of the project.
Planner and coordinator for CMC activities for a given project.
CMC representative in the project team.
Expert of either API synthesis, formulation, or analytical science depends on project requirement.
Nominated by CMC head when Visirna project team formed (before PCC for internal projects or CMC participation is required for in-licensed projects).
Responsibilities of CMC TDL:
1. Strategic planning:
Drive preparation of draft QTPP based on project requirement (e.g. TPP) and input from various functions (CD, RA, BD, CMC, QA, etc.).
Collect information from potential customers (non-clinical safety, clinical, etc.) to generate materials demand, then propose manufacturing batch size and schedule.
Propose a stage appropriate technical development plan to maximize the opportunity of process/control optimization.
2. Resource management:
Coordinate internal team, including CMC and other functions, to complete required CMC tasks.
Propose budget projection for CMC activities.
Prepare RFPs, coordinate vendor selection process, define deliverables & milestones in the contract.
3. Technical champion:
Drive innovation and execution excellence, instill high standard to external vendors.
Identify the technical hurdles and risks in CMC development, propose solutions to ensure on time delivery of quality products.
Identify opportunities for process/control optimization, oversee development activities at CDMO.
Drive introduction of new technologies, especially chemoenzymatic synthesis of oligonucleotides.
Seek opportunity to build up IP in DS/DP manufacturing technology.
4. Document preparation:
Coordinate preparation of the initial technical package for early process development and batch production.
Review technical documents, including R&D reports, validation protocols/reports, campaign reports, batch records, etc. prepared by CDMO.
Ensure the quality of Lab Notebook documentation at CDMO.
Author internal development report.
Coordinate preparation of tech-transfer package.
Coordinate preparation the technical part of CMC patent application.
Coordinate preparation the CMC sections for RA documents, such as IND, NDA, DSUR, and PPT/RTQ for regulatory communication.
5. Project alliance:
Monitor project progress, identify potential bottlenecks, and propose actionable solutions.
Update progress and status of CMC development to project team.
Communicate urgent issues and critical risks to project team and Visirna MT.
Manage relationships with CDMOs and other key suppliers to ensure timely delivery of high-quality materials.
