Associate Director, CMC Lead

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

Benefits offered by this job

Short-term incentive bonuses

Equity-based awards

Health, dental, and vision coverage

Job summary

AstraZeneca is seeking an Associate Director, CMC Lead in the United States to steer early-stage CMC strategy and IND-enabling plans for alpha-emitting radioconjugates. You will lead API, drug product, and analytical development, coordinating with Clinical and Regulatory teams to ensure timely readiness for first-in-human studies.

Join a team advancing radiopharmaceuticals with state-of-the-art manufacturing capabilities.

Qualifications

• 7+ years of experience in pharmaceutical/biopharmaceutical product development and manufacturing.
• Bachelor's degree required; advanced degree preferred in Biochemistry, Pharmaceutical Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering, or related field.
• Experience leading early-phase CMC development including IND-enabling activities, process development, and analytical method development.
• Strong project leadership with ability to manage multiple programs across maturity levels.
• Excellent interpersonal and communication skills to collaborate across functions and influence stakeholders.
• Ability to develop phase-appropriate CMC strategies across API, DP, and Analytical.
• Experience in a matrix environment leading cross-functional sub-teams.

Responsibilities

• Define and deliver the pre-IND/IND-enabling CMC strategy to drive first-in-human readiness.
• Lead CMC regulatory strategy and contribute to IND/IMPD filings.
• Coordinate API, drug product, and analytical development to enable robust, scalable processes.
• Build and execute Phase 0/Phase I clinical supply strategies with isotope availability and shelf life considerations.
• Manage multiple early-stage programs, setting priorities and aligning timelines.
• Represent CMC on project teams and inform candidate selection with data-driven risk assessments.
• Evaluate new targets and modalities for CMC feasibility and developability.
• Partner with Program Management, Clinical, Regulatory, Quality, and Supply Chain to enable smooth transitions.

Skills

CMC development

Leadership

Cross-functional collaboration

Regulatory strategy

Project management

Education

Bachelor's degree

Advanced degree preferred

Tools

IND/IMPD documentation

Job description

Job Title: 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 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.

Accountabilities

• 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 developability 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.

Essential Skills/Experience

• 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.

Desirable Skills/Experience

• 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.

The annual base pay (or hourly rate of compensation) for this position ranges from $136,514 USD to $204,771 USD. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Why AstraZeneca:Here you will follow the science with the resources to act on it, working alongside radiochemists, data scientists, clinicians, and CMC leaders who challenge assumptions and unlock new solutions together. We invest deeply in understanding disease biology and harness digital, data science, and AI to better predict clinical success, accelerating promising assets without compromising quality. Expect an environment that values kindness alongside ambition, where bold ideas are welcomed, thoughtful risks are supported, and your expertise directly shapes how innovative medicines reach patients sooner.

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