Associate Director, CMC Lead — Radiopharma

AstraZeneca GmbH; Boston (MA); On-site; USD 137,000 - 205,000; Full time

Benefits offered by this job

Short-term incentives

Equity awards

Retirement plan

Paid time off

Job summary

AstraZeneca is seeking an Associate Director, CMC Lead to drive early-stage CMC strategy across a portfolio of radiopharmaceuticals, aligning IND-enabling plans and establishing phase-appropriate clinical supply foundations. You will steer development decisions that move candidates from discovery toward first-in-human studies while balancing scientific rigor and speed.

This role requires leadership across functions, strong communication, and experience managing multiple concurrent early-stage

Qualifications

• 7+ years in pharmaceutical/biopharmaceutical product development and manufacturing.
• Bachelor's degree minimum; advanced degree preferred in Biochemistry, Pharmaceutical Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering, or related.
• Experience managing early-phase CMC development including IND-enabling activities, process development, and analytical method development.

Responsibilities

• Define and deliver the pharmaceutical development strategy for pre-IND/IND-enabling portfolio to drive timely progression to first-in-human readiness.
• Lead CMC regulatory strategy and contribute to high-quality IND/IMPD documentation and data packages.
• Coordinate API, drug product and analytical development to establish robust, scalable, phase-appropriate processes and methods.
• Build and execute supply strategies for Phase 0/Phase I, ensuring isotope availability, shelf life, and study timelines for clinical material.
• Manage multiple early-stage programs; set priorities, balance resources, and adapt strategies as data emerges.
• Represent CMC on project teams; inform candidate selection through data-driven risk/benefit assessments.
• Evaluate new targets and modalities for CMC feasibility to guide investment decisions.
• Partner with Program Management, Clinical, Research, Regulatory, Quality, and Supply Chain to enable progression from research to early development.

Skills

CMC development

IND/IMPD readiness

Cross-functional leadership

Project management

Interpersonal skills

Matrix environment

Analytical thinking

Radiopharmaceuticals

Education

Bachelor's degree

Advanced degree preferred

Job description

AstraZeneca is seeking an Associate Director, CMC Lead to drive early-stage CMC strategy across a portfolio of radiopharmaceuticals, aligning IND-enabling plans and establishing phase-appropriate clinical supply foundations. You will steer development decisions that move candidates from discovery toward first-in-human studies while balancing scientific rigor and speed.

This role requires leadership across functions, strong communication, and experience managing multiple concurrent early-stage