CMC Program Lead

See Yourself at Telix

As the CMC Program Lead, you will play a critical role in ensuring successful development and manufacturing of the company’s radiopharmaceutical assets.  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 in 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 from first-in- human testing phases to all later phases of development, including pivotal Phase 2/3 studies and NDA/MAA/BLA submissions
• Represent the CMC team on the global matrix team for the assigned project/s
• 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 Quality and CMC SMEs, and serve as a relationship lead
• 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 project.
• Develop global CMC program hand-offs to enable 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.
• 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 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 to manage collaborations with global team members and CDMOs.

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 out opportunities to expand your knowledge and skills