Full-Time CMC Program Lead
Telix Pharmaceuticals (Americas) is hiring a remote Full-Time CMC Program Lead. The career level for this job opening is Manager and is accepting USA based applicants remotely. Read complete job description before applying.
Telix Pharmaceuticals (Americas)
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Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company. Our mission is precision medicine via targeted radiation.
As the CMC Program Lead, you will ensure successful development and manufacturing of radiopharmaceutical assets, from early clinical phases to submissions.
Key Accountabilities:
- Plan, coordinate, and deliver CMC strategies.
- Represent the CMC team on the global matrix team.
- Lead internal CMC project teams.
- Establish and maintain project dashboards, timelines, and budgets.
- Track deliverables, approve invoices, and ensure alignment with project plans.
- Outline CMC risks and mitigation strategies.
- Provide regular updates to senior management.
- Lead CDMO/CMO vendor selection.
- Partner with key stakeholders (Global Product Development Leads, etc.).
- Develop global CMC program hand-offs.
- Facilitate team meetings and communication.
- Identify process gaps and implement solutions.
Education and Experience:
- BA/BS degree in Science, Mathematics, Engineering, or related field.
- 10+ years of radiopharmaceutical/pharmaceutical/biopharma CMC experience.
- 5+ years of CMC program/project management experience.
- Cross-functional team experience with external partners and CDMOs.
- Strong communication, collaboration, and change management skills.
- Knowledge of FDA and global regulatory requirements.
- Technical understanding of manufacturing, radiopharmaceuticals, and product/process development.
- MS Office, project management software (e.g., SAP, MS Project, Smartsheet) experience.
- Matrix-managed environment experience.
Key Capabilities:
- Inclusive mindset
- Creativity and innovation
- Commitment to excellence
- Results-oriented
- Ethical behavior
- Adaptability
- Strong communication skills
- Collaboration
- Resilience
- Continuous learning