CMC Program Lead, Commercial Radiochemistry

Telix Pharmaceuticals (AMER)

5d•Hybrid

About The Position

The CMC Program Lead, Commercial Radiochemistry will play a critical role in ensuring the successful readiness of the company’s radiopharmaceutical assets for commercial launch and ongoing commercial viability. This role involves 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).

Requirements

BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline required
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.

Responsibilities

Plan, 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 management
Represent the CMC team on the global matrix team for the assigned projects, along with the CMC PL covering non-radioactive manufacturing
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.