CMC Program Lead, Commercial Radiochemistry

Telix Pharmaceuticals (AMER); United States; Hybrid; USD 180,000 - 230,000; Full time

Job summary

Telix Pharmaceuticals seeks a CMC Program Lead to drive commercial-ready radiopharmaceutical CMC activities in a fast-paced, global setting. You will coordinate cross-functional teams, manage external CDMOs, and maintain timelines, budgets, and risk plans to ensure successful filings and lifecycle management.

You will partner with Global Product Development, Brand Leads, and external partners to enable seamless transitions from development to commercial stages while supporting ongoing lifecycle

Qualifications

• 8+ years in radiopharmaceutical/biopharma CMC with program/PM experience
• Experience working with cross-functional teams and external partners/CDMOs
• Strong knowledge of FDA/global regulatory requirements and product/process development

Responsibilities

• Plan, coordinate, and deliver CMC strategies, plans and deliverables through pivotal trials to filing readiness
• Represent CMC on global matrix teams for assigned projects
• Lead internal CMC project teams with SMEs, Supply Chain, Quality and Regulatory
• Establish and maintain CMC project dashboards, timelines and budgets
• Track deliverables, approve invoices, and ensure CMC plans are integrated into project plans
• Outline risks and mitigation strategies and communicate to senior management
• Provide regular CMC updates to senior management on status, timelines, risks and KPIs
• Lead vendor selection with CDMO/CMO partners and manage external relationships
• Collaborate with stakeholders across Global Product Development Leads, Brand Leads, and CDMOs to manage interdependencies
• Facilitate cross-functional team meetings and maintain meeting records and risk analyses
• Identify gaps in processes and drive improvements

Skills

CMC Leadership

Cross-functional teamwork

Regulatory knowledge

MS Office

Education

BS in Science/Engineering

Tools

SAP

MS Project

Smartsheet

Job description

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.

See Yourself at Telix

As the CMC Program Leadcovering commercial/pre-commercial radiochemistry, you will play a critical role in ensuring successfulreadinessof the company’s radiopharmaceutical assetsfor commercial launchand ongoing commercial viability.Ensuring the effective execution of CMC strategies through the cross functional collaboration of internal and external partners.The CMC Program Lead willbe responsible forcoordinating and delivering CMC activitiesat radiochemical production partnersin line with project requirements and company goals for assigned CMC development programs (Precision Medicine Diagnostics or Therapeutics).

Key Accountabilities:

• Plan, coordinate, and deliver CMC strategies, plans, and deliverables for radiopharmaceutical drug candidates includinga hand-off atpivotal Phase 3 studiesthrough filing readiness,NDA/MAA/BLA submissions, andultimatelyongoingcommercial life-cycle management
• Along with the CMC PL covering non-radioactive manufacturing, representing the CMC team on the global matrix team for the assigned projects
• Facilitate, manage, and lead internal CMC project teams comprised of technical CMC SMEs, Supply Chain, Logistics, Validation, Quality, Clinical Ops, and Regulatory
• Establish and maintain CMC project dashboards, timelines, and budgets for assigned projects
• Track CMC deliverables, approve invoices, and ensure the CMC strategies and plans are incorporated into the overall project plans
• Proactively outline CMC risks and mitigation strategies, and communicate risks and issues to project teams and senior management
• Provide regular CMC updates to senior management on project status, timelines, risks, issues, KPIs, and forecasting for future project needs
• Lead 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 partners
• Partner 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 program
• Partner with development CMC Program Leads to plan hand-offs enabling smooth transitions from development to commercial and lifecycle management
• 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.

Education and Experience:

• BA or BS degree in Science, Mathematics, Engineering, or a related scientific disciplinerequired
• 8+ 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 required
• Excellent communication, collaboration, and change management skills
• Robust knowledge of FDA and global regulatory requirements. Also possesses a strong technical understanding of manufacturing, radiopharmaceuticals, and product/process development
• Must 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 processes
• Able to thrive in a highly dynamic, fast paced, continuously changing global environment with minimal oversight/direction.
• Ability to travel 10-25% to manage collaborations with global team members and CDMOs.

Key Capabilities:

• 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
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to 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
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

At 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. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity 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.

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