[Hiring] CMC Program Lead @AMER

Role Description

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 Lead covering Illuccix and Gozellix, you will play a critical role in ensuring successful readiness of the company’s radiopharmaceutical assets for ongoing commercial viability, market expansion, and process improvement.

• Ensuring the effective execution of CMC strategies through cross-functional collaboration of internal and external partners.
• Coordinating and delivering CMC activities at API, Fill/Finish, and Secondary Packaging partners in line with project requirements and company goals.
• Driving activities across the CMC disciplines as the program matrix team representative for CMC.

Qualifications

• BA or BS degree in Business, Science, Mathematics, Engineering, or a related scientific discipline required.
• 8+ years of relevant radiopharmaceutical/pharmaceutical/biopharma CMC experience with (optional) 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.
• Strong technical understanding of manufacturing, radiopharmaceuticals, and product/process development.
• 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 and 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 10-20% to manage collaborations with global team members and CDMOs.

Requirements

• Plan, coordinate, and deliver CMC strategies, plans, and deliverables for radiopharmaceutical drug candidates.
• 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, initiate PO requests, drive out of budget requests, 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.
• Partner closely with all key stakeholders of the internal Telix teams to develop and maintain integrated project plans.
• 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.
• Plan program and commercial budget along with Supply Chain, Program Management, and Finance.
• Drive change controls for complex CMC items such as product launch in expanded regions, product labeling changes, process improvement requiring filings, and more.

Benefits

• 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.
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise.
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges.
• Inclusive mindset: 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.
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions.
• Continuous learning: Show a commitment to ongoing learning and professional development.