[Hiring] CMC Program Lead @AMER

Role Description

The CMC Program Lead is responsible for leading the CMC Sub-Team and serving as the single point of contact for all CMC topics on the program matrix for early-stage antibody-conjugate radiopharmaceutical diagnostic and therapeutic assets. The CMC Lead will develop, execute, and maintain the integrated CMC strategy and plan grounded in Quality by Design (QbD) principles, aligned to Stage-Gate requirements, spanning Drug Substance, Drug Product, Analytical Development, and Supply Chain from preclinical development through end of phase 1 (first-in-human).

As the cross-functional integrator, the CMC Lead is the accountable owner for all CMC deliverables, establishing relationships with functional SMEs, internal manufacturing sites, and external partners to drive alignment, decision documentation, risk management, and Stage-Gate readiness. This position is part of the CMC Programs team within the Radiopharmaceutical Development group in Global Operations.

Key Accountabilities:

• Develop, own, and execute CMC strategies for antibody-based radiopharmaceutical drug candidates across the portfolio, from preclinical development through clinical supply.
• Apply QbD principles (target product profile, critical quality attributes, critical process parameters, control strategy) to drive science-based CMC development aligned to Stage-Gate expectations and readiness criteria.
• Serve as the single point of accountability and key point of contact for all CMC matters within the program matrix.
• Lead the CMC Sub-Team and represent the CMC function within the broader program governance structure.
• Coordinate functional SMEs across Drug Substance, Drug Product, Analytical Development, QC, QA, Supply Chain, Validation, and Regulatory CMC across multiple Telix sites.
• Own and maintain the integrated CMC plan, risk register, decision log, and project dashboards for assigned programs.
• Track CMC deliverables across multiple concurrent targets.
• Maintain relationships with internal and external partners, including contract management, budgeting, invoice approval, and ensuring CMC timelines are integrated with overall program plans and Gate-readiness milestones.
• Proactively identify CMC risks and develop mitigation strategies.
• Prepare Gate-readiness packages with documented evidence of deliverable completion, open risks, and residual risk rationale.
• Provide regular CMC updates to senior management and program governance on project status, timelines, risks, Stage-Gate readiness, and resource forecasting.
• Coordinate with internal manufacturing sites and external CDMOs/CMOs for Drug Substance and Drug Product supply.
• Partner with internal Telix stakeholders and collaboration partner counterparts to manage cross-functional dependencies and critical path activities.
• Develop CMC technology transfer packages and handoff documentation to enable transitions between development phases.
• Facilitate team meetings using project management best practices/tools.
• Organize and maintain CMC team communications including meeting agendas, minutes, decision logs, task lists, and risk analyses/mitigation strategies.
• Identify gaps in processes, then work with appropriate parties to develop and implement solutions.
• Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable.

Qualifications

• BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline required.
• 10+ years of relevant radiopharmaceutical/pharmaceutical/biopharma CMC experience with 5+ years of CMC program/project management experience.
• Experience with biologics (monoclonal antibodies, bioconjugates) and/or radiopharmaceuticals is required.
• Experience managing pharmaceutical alliance/partnership programs or multi-site CMC execution within a matrix operating model.
• Excellent communication, collaboration, and change management skills.
• Robust knowledge of FDA and global regulatory requirements (IND, NDA/BLA) applicable to 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 (QbD) principles.
• Strong experience in project management across drug development lifecycle.
• Strong foundational collaboration skills with experience working in a successful matrix managed environment.
• Ability to demonstrate initiative and suggest improvements to current systems.
• Able to thrive in a highly dynamic, fast-paced, continuously changing global environment.
• Ability to travel to manage collaborations with global team members and CDMOs (minimal).

Key Capabilities

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity.
• Creativity and innovation: Possess a willingness to think outside the box.
• Commitment to excellence: Take pride in your work and strive for excellence.
• Results-oriented: Driven to achieve goals and objectives.
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior.
• Adaptability: Comfortable working in a dynamic environment.
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders.
• Collaboration: Work effectively as part of a team.
• Resilience: Demonstrate the ability to bounce back from setbacks.
• Continuous learning: Show a commitment to ongoing learning and professional development.