Associate Director, CMC Lead

AstraZeneca•Boston, MA

6d•Hybrid

About The Position

Are you ready to lead early-stage CMC strategy that turns precision radioconjugate 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 radioconjugates 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.

Requirements

7+ years of experience in pharmaceutical/biopharmaceutical product development and manufacturing
Minimum education: Bachelor's degree.
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.

Nice To Haves

Advanced degree in Biochemistry, Pharmaceutical Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering, or related scientific discipline preferred.
Experience with radiopharmaceuticals or radioconjugates, 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 facilities and effective collaboration with external partners or CDMOs.
Understanding of analytical method lifecycle, including phase-appropriate validation and control strategy development.

Responsibilities

Define and deliver the pharmaceutical development strategy for the pre-IND/IND-enabling portfolio to drive timely progression to first-in-human readiness.
Lead CMC regulatory strategy; guide and contribute to authoring high-quality documentation and data packages for IND/IMPD submissions.
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, aligning isotope availability, shelf life, and study timelines to ensure on-time, fit-for-purpose clinical material.
Manage multiple early-stage programs; set priorities, balance resources, and adjust strategies as data emerge to protect the critical path.
Represent CMC on project teams; shape overall program strategies and inform candidate selection through clear, data-driven risk/benefit assessments.
Evaluate new molecular targets and modalities for CMC feasibility and developability to guide investment decisions.
Partner with Program Management, Clinical, Research, Regulatory, Quality, and Supply Chain to enable seamless movement of candidates from research into early development.