Remote opportunity at
Telix Pharmaceuticals LimitedCMC Program Lead TLX597 & TLX66
Telix Pharmaceuticals Limited seeks a CMC Program Lead to direct chemistry, manufacturing, and controls efforts for early-stage antibody-conjugate radiopharmaceutical diagnostic and therapeutic assets under a co-development…
Career Tools
About This Role
Telix Pharmaceuticals Limited seeks a CMC Program Lead to direct chemistry, manufacturing, and controls efforts for early-stage antibody-conjugate radiopharmaceutical diagnostic and therapeutic assets under a co-development partnership. This remote position operates within the Radiopharmaceutical Development group under Global Operations, acting as the primary point of contact and head of the CMC Sub-Team for the TLX597 and TLX66 portfolio. The professional in this role will build, guide, and manage an integrated…
Job Description
Telix Pharmaceuticals Limited seeks a CMC Program Lead to direct chemistry, manufacturing, and controls efforts for early-stage antibody-conjugate radiopharmaceutical diagnostic and therapeutic assets under a co-development partnership. This remote position operates within the Radiopharmaceutical Development group under Global Operations, acting as the primary point of contact and head of the CMC Sub-Team for the TLX597 and TLX66 portfolio. The professional in this role will build, guide, and manage an integrated CMC strategy encompassing analytical development, supply chain, drug substance, and drug product from preclinical phases up to phase 3. Responsibilities include utilizing Quality by Design standards, handling risk management, tracking milestones, and coordinating internal sites alongside external contract development and manufacturing organizations. Candidates must have extensive biopharma experience and a strong background in program management.
Responsibilities
- Manage and execute CMC strategies for antibody-based radiopharmaceutical drug candidates across the TLX597 and TLX66 portfolio
- Direct the CMC Sub-Team and represent the function in program governance structures
- Apply Quality by Design principles to guide science-based CMC development
- Maintain the integrated CMC plan, risk register, decision log, and dashboards
- Monitor deliverables, contracts, budgets, and timelines across multiple concurrent targets
- Identify potential risks early and formulate mitigation strategies
- Prepare Gate-readiness packages and deliver project status updates to senior leadership
- Coordinate drug substance and drug product supply with internal manufacturing sites and external partners
Requirements
- 10+ years of relevant radiopharmaceutical, pharmaceutical, or biopharma CMC experience
- 5+ years of CMC program or project management experience
- Experience with biologics such as monoclonal antibodies or bioconjugates, and radiopharmaceuticals
- Experience managing pharmaceutical alliance programs or multi-site CMC execution within a matrix environment
- Familiarity with FDA and global regulatory requirements for radiopharmaceuticals and biologics
- Technical understanding of antibody manufacturing, bioconjugation, radiochemistry, and drug product fill-finish
- Familiarity with ICH Q8-Q12 guidelines and Quality by Design principles
Qualifications
- Bachelor of Arts or Bachelor of Science degree in Science, Mathematics, Engineering, or a related scientific discipline
Core Skills
Benefits
- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the remote status of this role?
This position is remote.
What are the employment type and salary details?
The role is full-time, but the specific salary is not stated in the job posting.
What education is required for this position?
Applicants must hold a BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline.
Sample Interview Questions
AI-generated questions tailored to this specific role — a preview of the full practice set.