Associate Director, CMC Development

Summary

The Associate Director, CMC Development provides scientific and cross-functional leadership for radiopharmaceutical development programs spanning discovery through First-in-Human readiness. The role integrates radiochemistry, analytical sciences and early CMC activities to advance multiple imaging and therapeutic radiopharmaceutical assets.

Working closely with Discovery, CMC, Technical Operations, Quality, Regulatory Affairs, Clinical Development, and external CDMOs, the Principal Scientist drives technical strategy, manufacturing readiness, and cross-functional execution across the development portfolio.

Responsibilities

• Lead development of imaging and therapeutic radiopharmaceutical programs from discovery through clinical readiness.
• Define radiochemistry strategies, radiolabelling processes, formulation approaches, and analytical development plans.
• Drive technical decision-making based on scientific, analytical, and manufacturing data.
• Lead early CMC strategy across multiple development programs.
• Support preparation of CMC documentation for regulatory submissions (IND/IMPD).
• Support process scale-up, manufacturing readiness, troubleshooting, and clinical supply planning.
• Collaborate closely with TechOps and external manufacturing partners.

Cross-functional Leadership

• Coordinate activities across Discovery, CMC, QA, Regulatory, TechOps, Clinical Development, and external collaborators.
• Identify technical and operational risks and develop mitigation strategies.
• Present scientific recommendations to senior leadership.

People Leadership

• Lead and mentor a multidisciplinary radiochemistry team.
• Build scientific capabilities, establish best practices, and promote operational excellence.
• Support recruitment, onboarding, and career development of scientists.

Qualifications & Experience

• PhD in Radiochemistry, Chemistry, Pharmaceutical Sciences, Medicinal Chemistry, or a related scientific discipline.
• 10+ years of relevant experience in radiopharmaceutical development, biotechnology, the pharmaceutical industry, or academia.
• Strong expertise in radiochemistry, analytical development, and early CMC.
• Experience with GMP principles, clinical manufacturing readiness, and technology transfer.
• Experience working with external CDMOs and multidisciplinary project teams.
• Excellent communication, leadership, and project management skills.

Preferred

• Experience with alpha therapeutic radiopharmaceuticals.
• Knowledge of GMP and radiopharmaceutical manufacturing environments.
• Experience supporting clinical-stage development programs.
• Experience working with CDMOs and technology transfer activities.
• Familiarity with regulatory expectations for radiopharmaceutical development.
• Experience with automated synthesis platforms and manufacturing equipment.

Personal Attributes

• Proactive, detail-oriented, and eager to learn.
• Comfortable working in a fast-paced biotech environment.
• Team player who thrives on collaboration and cross-functional flexibility.
• Commitment to safety and continuous improvement.

What We Offer

• A unique chance to contribute to first-in-class cancer therapies.
• Exposure to both radiochemistry and CMC development in a dynamic biotech setting.
• Hands-on training and professional development opportunities.
• An international, collaborative, and supportive work culture.
• Competitive compensation and benefits.