Associate Director, CMC Lead

Job Title:

Associate Director, CMC Lead

Introduction to role:
Are you ready to lead early-stage CMC strategy that turns precision radio conjugate science into first-in-human reality? As Associate Director, CMC Lead, you will steer development across a portfolio of alpha-emitting, tumor-targeted medicines, shaping IND-enabling plans and building the foundations for reliable, phase-appropriate clinical supply. Your decisions will determine how fast promising candidates move from discovery to patients.

You will join a team pushing the boundaries of oncology through novel radio conjugates and smart combinations, supported by state-of-the-art radiopharmaceutical manufacturing capabilities and an advancing clinical pipeline. How will you prioritize across multiple candidates, balance scientific rigor with speed, and de-risk the path to first-in-human studies? If you thrive in a dynamic, matrixed environment and enjoy solving complex CMC puzzles, this role puts you at the center of impact.

• Phase 0 CMC Strategy:
  Define and deliver the pharmaceutical development strategy for the pre-IND/IND-enabling portfolio to drive timely progression to first-in-human readiness.
• IND/IMPD Readiness:
  Lead CMC regulatory strategy; guide and contribute to authoring high-quality documentation and data packages for IND/IMPD submissions.
• API/Drug Product/Analytical Integration:
  Coordinate API, drug product, and analytical development to establish robust, scalable, phase-appropriate processes and methods.
• Clinical Supply Strategy:
  Build and execute supply strategies for Phase 0/Phase I, aligning isotope availability, shelf life, and study timelines to ensure on-time, fit-for-purpose clinical material.
• Portfolio Leadership:
  Manage multiple early-stage programs; set priorities, balance resources, and adjust strategies as data emerge to protect the critical path.
• Cross-Functional Influence:
  Represent CMC on project teams; shape overall program strategies and inform candidate selection through clear, data-driven risk/benefit assessments.
• Target and Modality Assessment:
  Evaluate new molecular targets and modalities for CMC feasibility and develop ability to guide investment decisions.
• Transition Enablement:
  Partner with Program Management, Clinical, Research, Regulatory, Quality, and Supply Chain to enable seamless movement of candidates from research into early development.

• 7+ years of experience in pharmaceutical/biopharmaceutical product development and manufacturing;
• Minimum education:
  
  Bachelor's degree. Advanced degree in Biochemistry, Pharmaceutical Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering, or related scientific discipline preferred.
• Demonstrated experience managing early-phase CMC development, including IND-enabling activities, process development, and analytical method development.
• Strong project leadership skills with the ability to manage multiple concurrent programs at varying stages of maturity.
• Demonstrated strong interpersonal and communication skills with the ability to collaborate effectively across functions and influence stakeholders at multiple levels of the organization.
• Ability to develop and implement phase-appropriate pharmaceutical strategies across CMC areas (API, DP, Analytical) aligned with overall program objectives and timelines.
• Experience working in a matrix environment and leading cross-functional sub-teams to deliver against defined milestones.
• Strong problem-solving aptitude with the ability to navigate ambiguity and make sound technical and strategic judgments in a data-limited, early-stage environment.

• Experience with radiopharmaceuticals or radio conjugates, including awareness of radiochemistry constraints and alpha-emitting isotopes.
• Prior authorship or leadership of CMC sections for IND/IMPD filings for biologics, conjugates, or complex modalities.
• Familiarity with clinical supply strategies for short half-life or just-in-time manufactured products.
• Hands-on application of Quality by Design, design of experiments, and risk management in early development.
• Track record of successful tech transfer to GMP…