Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States.
Our mission is to deliver on the promise of precision medicine through targeted radiation.
At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases.
You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.As the CMC Program Leadcovering commercial /pre-commercial radiochemistry , you will play a critical role in ensuring successful readiness of the company's radiopharmaceutical assets for commercial launch and ongoing commercial viability .
Ensuring the effective execution of CMC strategies through the cross functional collaboration of internal and external partners.
The CMC Program Lead will be responsible for coordinating and delivering CMC activities at radiochemical production partners in line with project requirements and company goals for assigned CMC development programs (Precision Medicine Diagnostics or Therapeutics).
Key AccountabilitiesPlan, coordinate, and deliver CMC strategies, plans, and deliverables for radiopharmaceutical drug candidates including a hand-off at pivotal Phase 3 studies through filing readiness, NDA/MAA/BLA submissions, and ultimately ongoing commercial life-cycle managementAlong with the CMC PL covering non-radioactive manufacturing, representing the CMC team on the global matrix team for the assigned projectsFacilitate, manage, and lead internal CMC project teams comprised of technical CMC SMEs, Supply Chain, Logistics, Validation, Quality, Clinical Ops, and RegulatoryEstablish and maintain CMC project dashboards, timelines, and budgets for assigned projectsTrack CMC deliverables, approve invoices, and ensure the CMC strategies and plans are incorporated into the overall project plansProactively outline CMC risks and mitigation strategies, and communicate risks and issues to project teams and senior managementProvide regular CMC updates to senior management on project status, timelines, risks, issues, KPIs, and forecasting for future project needsLead CDMO/CMO CMC vendor selection process in collaboration with Procurement, Quality and CMC SMEs,



and serve as the relationship lead to our internal and external contract manufacturing partnersPartner closely with all key stakeholders of the internal Telix teams, including Global Product Development Leads, Global Brand Leads, and external CDMO/CMOs to develop and maintain integrated project plans to identify/communicate interdependencies as well as critical path activities for the programPartner with development CMC Program Leads to plan hand-offs enabling smooth transitions from development to commercial and lifecycle managementFacilitate team meetings using project management best practices/tools to drive cross-functional communication, timely and effective decision making, and successful execution of project objectivesOrganize and maintain CMC team communications including meeting agendas, minutes, decision logs, task lists, and risk analyses/mitigation strategiesIdentify gaps in processes, then work with appropriate parties to develop and implement solutionsEducation and ExperienceBA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline required8+ years of relevant radiopharmaceutical/pharmaceutical/biopharma CMC experience with 2+ years of CMC program/project management experience.Experience in working with cross-functional teams, external partners and CDMOs requiredExcellent communication, collaboration, and change management skillsRobust knowledge of FDA and global regulatory requirements.Also possesses a strong technical understanding of manufacturing, radiopharmaceuticals, and product/process developmentMust have strong experience in MS Office suite applications and management software (e.g., SAP, MS Project, Smartsheet)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 processesAble 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.Key CapabilitiesCommitment to excellence: Take pride in your work and consistently strive for excellence in everything you doResults-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable resultsCreativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challengesStrong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise languageCollaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goalsResilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challengesInclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respectedAdaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challengesEthical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholdersContinuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skillsAt Telix, we believe everyone counts , we strive to be extraordinary , and we pursue our goals with determination and integrity .
You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives.
Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine.
We have hybrid and remote employees located all around the world.competitive salariesannual performance-based bonusesequity-based incentive programgenerous vacationpaid wellness dayssupport for learning and developmentTelix Pharmaceuticals is an equal chance employer.
We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.We have hybrid and remote employees located all around the world.
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📌 Cmc Program Lead, Commercial Radiochemistry (Brisbane)
🏢 Telix Pharmaceuticals
📍 Brisbane