CMC Program Lead TLX597 & TLX66

Telix Pharmaceuticals (AMER)

About The Position

The CMC Program Lead for TLX597 and TLX66 leads the CMC Sub-Team and serves as the single point of contact and accountable owner for CMC topics and deliverables across early-stage antibody-conjugate radiopharmaceutical diagnostic and therapeutic programs developed through a co-development collaboration. The role develops, executes, and maintains an integrated CMC strategy and plan grounded in Quality by Design (QbD) principles and aligned with Stage-Gate requirements. Its scope spans Drug Substance, Drug Product, Analytical Development, and Supply Chain from preclinical development through Phase 3. As a cross-functional integrator, the CMC Program Lead coordinates functional subject-matter experts, internal manufacturing sites, collaboration partners, and external CDMOs/CMOs. The role manages CMC plans, risks, decisions, timelines, budgets, partner relationships, and Gate-readiness, while providing updates to senior management and program governance. It is part of the CMC Programs team within the Radiopharmaceutical Development group in Global Operations.

Requirements

BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline.
At least 10 years of relevant radiopharmaceutical, pharmaceutical, or biopharma CMC experience.
At least 5 years of CMC program or project management experience.
Experience with biologics (including monoclonal antibodies or bioconjugates) and/or radiopharmaceuticals.
Experience managing pharmaceutical alliance or partnership programs, or multi-site CMC execution within a matrix operating model, with demonstrated ability to drive cross-functional integration and escalation through governance structures.
Excellent communication, collaboration, and change-management skills.
Knowledge of FDA and global regulatory requirements applicable to radiopharmaceuticals and biologics, including IND and NDA/BLA requirements.
Technical understanding of antibody manufacturing, including upstream and downstream processing, bioconjugation, radiochemistry, and drug product fill/finish.
Familiarity with ICH Q8–Q12 guidelines and QbD principles, including TPP, CQAs, CPPs, and control-strategy development.
Strong project-management experience across the drug-development lifecycle.
Foundational collaboration skills and experience working successfully in a matrix-managed environment.
Ability to demonstrate initiative, suggest improvements to existing systems, and establish new processes.
Ability to work in a dynamic, fast-paced, continuously changing global environment with minimal oversight or direction.
Ability to travel minimally to manage collaborations with global team members and CDMOs.

Responsibilities

Develop, own, and execute CMC strategies for antibody-based radiopharmaceutical drug candidates across the TLX597 and TLX66 portfolio, from preclinical development through clinical supply.
Apply QbD principles, including target product profile, critical quality attributes, critical process parameters, and control strategy, to guide science-based CMC development aligned with Stage-Gate requirements.
Serve as the single accountable owner and point of contact for CMC matters within the program matrix; lead the CMC Sub-Team and represent CMC in broader program governance.
Coordinate functional SMEs across Drug Substance, Drug Product, Analytical Development, QC, QA, Supply Chain, Validation, and Regulatory CMC across multiple sites.
Own cross-functional integration and ensure CMC development activities follow QbD principles and sound scientific rationale.
Maintain integrated CMC plans, risk registers, decision logs, and project dashboards, and ensure timelines, budgets, and deliverables are traceable to Stage-Gate requirements.
Track deliverables across concurrent targets and manage partner relationships, including contract management, budgeting, invoice approval, and integration of CMC timelines with program plans and Gate-readiness milestones.
Identify CMC risks, develop mitigation strategies, escalate issues early, and prepare Gate-readiness packages documenting completed deliverables, open risks, and residual-risk rationale.
Provide senior management and program governance with regular updates on status, timelines, risks, Stage-Gate readiness, and resource forecasting.
Coordinate Drug Substance and Drug Product supply with internal manufacturing sites and external CDMOs/CMOs; serve as CMC relationship lead for key partners and support delivery to contract, specification, and timeline.
Partner with internal stakeholders and collaboration partners to manage cross-functional dependencies and critical-path activities across preclinical and translational development, CMC IND package coordination, and clinical supply workstreams.
Enable CMC technology-transfer packages and handoff documentation for transitions between development phases.
Facilitate team meetings using project-management practices and tools to support communication, timely decision-making, and execution of project objectives.
Organize and maintain CMC team communications, including agendas, minutes, decision logs, task lists, and risk analyses and mitigation strategies.
Identify process gaps and work with appropriate parties to develop and implement solutions.
Perform duties in accordance with established SOPs and applicable GxP requirements.