CMC Program Lead

Telix Pharmaceuticals (AMER)

5d•Hybrid

About The Position

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.

Requirements

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).

Nice To Haves

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

Responsibilities

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.