CMC Program Lead - Radiopharma Global Programs

Openkrill; United States; Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Equity-based incentive program

Bonuses and performance incentives

Generous vacation

Wellness days

Learning and development support

Job summary

Telix Pharmaceuticals seeks a CMC Program Lead to ensure readiness of radiopharmaceutical assets for commercial viability and global expansion. You will coordinate CMC activities across API, Fill/Finish, and Secondary Packaging with internal teams and external partners.

You will drive cross-functional programs, manage timelines and budgets, and communicate risks to senior leadership while supporting lifecycle management and regulatory filings.

Qualifications

• BA or BS degree in Business, Science, Mathematics, Engineering, or a related scientific discipline required.
• 8+ years of radiopharmaceutical/pharmaceutical/biopharma CMC experience with (optional) 2+ years of CMC program/project management.
• Experience in working with cross-functional teams, external partners and CDMOs required.
• Excellent communication, collaboration, and change management skills.
• Robust knowledge of FDA and global regulatory requirements; strong technical understanding of manufacturing.
• Must have strong experience in MS Office suite applications and management software (e.g., SAP, MS Project, Smartsheet).
• Ability to thrive in a dynamic, global environment with travel 10-20%.

Responsibilities

• Plan, coordinate, and deliver CMC strategies, plans, and deliverables for radiopharmaceutical drug candidates through filing readiness.
• Represent the CMC team on the global matrix team for assigned projects.
• Lead internal CMC project teams across technical SMEs, Supply Chain, Validation, Quality, and Regulatory.
• Establish and maintain CMC project dashboards, timelines, and budgets.
• Track CMC deliverables, manage PO requests, and incorporate CMC plans into overall project plans.
• Outline CMC risks and mitigation strategies; communicate to management.
• Provide regular CMC updates to senior management on status and KPIs.
• Lead CDMO/CMO CMC vendor selection and manage relationships with manufacturing partners.
• Collaborate with Global Product Development Leads and external partners to maintain integrated plans.

Skills

Cross-functional

Communication

Change management

Initiative

Adaptability

Teamwork

Problem solving

Education

BA/BS in related field

Tools

SAP

MS Project

Smartsheet

Job description

Telix Pharmaceuticals seeks a CMC Program Lead to ensure readiness of radiopharmaceutical assets for commercial viability and global expansion. You will coordinate CMC activities across API, Fill/Finish, and Secondary Packaging with internal teams and external partners.

You will drive cross-functional programs, manage timelines and budgets, and communicate risks to senior leadership while supporting lifecycle management and regulatory filings.