CMC Program Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Play a vital role in the successful development and manufacturing of radiopharmaceutical assets.

• Ensure the effective implementation of CMC strategies through collaboration with internal and external partners.

• Coordinate and execute CMC activities in alignment with project requirements and company objectives.

• Plan, manage, and deliver CMC strategies, plans, and outcomes for drug candidates.

• Represent the CMC team within the global matrix team for 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 integrated into overall project plans.

• Proactively identify CMC risks and develop mitigation strategies.

• Provide regular updates to senior management on project status, timelines, and risks.

• Lead the CDMO/CMO vendor selection process in collaboration with Quality and Subject Matter Experts (SMEs).

• Collaborate closely with key stakeholders to create integrated project plans.

• Develop global CMC program transitions to ensure smooth shifts from development to commercial and lifecycle management.

• Facilitate team meetings utilizing project management best practices and tools.

• Organize and sustain CMC team communications.

⛳️ Requirements

• BA or BS degree in Science, Mathematics, Engineering, or a related scientific field is required.

• Over 10 years of relevant experience in radiopharmaceutical, pharmaceutical, or biopharma CMC, including more than 5 years of CMC program/project management experience.

• Experience collaborating with cross-functional teams, external partners, and CDMOs is required.

• Exceptional communication, collaboration, and change management capabilities.

• Comprehensive knowledge of FDA and global regulatory standards.

• Strong technical expertise in manufacturing, radiopharmaceuticals, and product/process development.

• Proficient in MS Office suite applications and management software (e.g., SAP, MS Project, Smartsheet).

• Solid foundational collaboration skills with experience in a successful matrix-managed environment.

• Demonstrated initiative, with the ability to recommend improvements to existing systems and establish new processes.

• Willingness to travel to manage collaborations with global team members and CDMOs.

🏝️ Benefits

• Competitive salaries.

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and development.