CMC Program Lead

 

See Yourself at Telix

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, ensuring all CMC questions, decisions, and deliverables are coordinated through a single accountable owner
• Lead the CMC Sub-Team for assigned programs, coordinating functional SMEs across Drug Substance (antibody/bioconjugate), Drug Product (radiochemistry/fill-finish), Analytical Development, QC, QA, Supply Chain, Validation, and Regulatory CMC across multiple Telix sites. In partnership with SMEs, own cross-functional integration and ensure CMC development activities are executed following QbD principles and sound scientific rationale
• Own and maintain the integrated CMC plan, risk register, decision log, and project dashboards for assigned programs, ensuring CMC timelines, budgets, and deliverables are traceable to Stage-Gate requirements
• 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. Escalate issues early, not when timelines are already at risk. 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. Serve as CMC relationship lead for key partner management, ensuring delivery to contract, specification, and timeline
• Partner with internal Telix stakeholders (R&D/Discovery, Translational Development, Radiochemistry, Regulatory, Quality, Supply Chain) and collaboration partner counterparts to manage cross-functional dependencies and critical path activities across preclinical, translational development, coordination of CMC IND package, and clinical supply workstreams.
• Develop CMC technology transfer packages and handoff documentation to enable transitions between development phases
• Facilitate team meetings using project management best practices/tools to drive cross-functional communication, timely and effective decision making, and successful execution of project objectives.
• 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.

Education and Experience:

• 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, with demonstrated ability to drive cross-functional integration and escalation within defined governance structures
• 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 (upstream/downstream processing), bioconjugation, radiochemistry, and drug product fill/finish. Familiarity with ICH Q8-Q12 guidelines and Quality by Design (QbD) principles, including target product profile (TPP), critical quality attributes (CQAs), critical process parameters (CPPs), and control strategy development
• Must have 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, suggest improvements to current systems as well as establish new processes
• Able to thrive in a highly dynamic, fast paced, continuously changing global environment with minimal oversight/direction.
• Ability to travel to manage collaborations with global team members and CDMOs (minimal).

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking opportunities to expand your knowledge and skills