Developing theranostics (nuclear medicine) for prostate, kidney, glioblastoma, haematologic cancers and rare diseases.
CMC Program Lead
Location
United States
Posted
2 days ago
Salary
0
Seniority
Senior
Job Description
CMC Program Lead
Telix Pharmaceuticals Limited
• Play a critical role in ensuring successful development and manufacturing of radiopharmaceutical assets • Ensure effective execution of CMC strategies through collaboration of internal and external partners • Coordinate and deliver CMC activities in line with project requirements and company goals • Plan, coordinate, and deliver CMC strategies, plans, and deliverables for drug candidates • Represent the CMC team on the global matrix team for the assigned projects • Facilitate, manage, and lead internal CMC project teams • Establish and maintain CMC project dashboards, timelines, and budgets • Track CMC deliverables, approve invoices, and ensure CMC strategies are incorporated into overall project plans • Proactively outline CMC risks and mitigation strategies • Provide regular updates to senior management on project status, timelines, and risks • Lead CDMO/CMO vendor selection process in collaboration with Quality and SMEs • Partner closely with key stakeholders to develop integrated project plans • 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 • Organize and maintain CMC team communications
Job 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 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, suggest improvements to current systems as well as establish new processes
- Ability to travel to manage collaborations with global team members and CDMOs
Benefits
- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
Related Guides
Related Categories
Related Job Pages
More General Jobs
Client Relations Specialist
Hello Sunshine TravelsHelping families, couples, and groups plan stress-free, unforgettable vacations—so all you have to do is pack.
• Handling customer inquiries and providing exceptional customer support • Responding to emails and phone calls • Resolving client issues • Assisting with travel bookings and reservations • Ensuring overall customer satisfaction • Working closely with the finance team to process payments, provide budgeting assistance, and manage invoices
Client Relations Specialist
Hello Sunshine TravelsHelping families, couples, and groups plan stress-free, unforgettable vacations—so all you have to do is pack.
• Handling customer inquiries and providing exceptional customer support • Responding to emails and phone calls • Resolving client issues • Assisting with travel bookings and reservations • Ensuring overall customer satisfaction • Working closely with the finance team to process payments and manage invoices
Client Relations Specialist
Hello Sunshine TravelsHelping families, couples, and groups plan stress-free, unforgettable vacations—so all you have to do is pack.
• Handling customer inquiries and providing exceptional customer support • Responding to emails and phone calls, resolving client issues • Assisting with travel bookings and reservations • Ensuring overall customer satisfaction • Working closely with the finance team to process payments, provide budgeting assistance, and manage invoices
Client Relations Specialist
Hello Sunshine TravelsHelping families, couples, and groups plan stress-free, unforgettable vacations—so all you have to do is pack.
• Handling customer inquiries and providing exceptional customer support • Responding to emails and phone calls • Resolving client issues • Assisting with travel bookings and reservations • Ensuring overall customer satisfaction • Working closely with the finance team to process payments • Providing budgeting assistance • Managing invoices
