Director, CMC Team Lead

AstraZeneca•New Haven, CT

5d•Hybrid

About The Position

This role offers the opportunity to lead the CMC strategy for high-potential therapies, guiding an asset from Candidate Selection through First Approval. The Director, CMC Team Lead will manage a cross-functional, matrix team responsible for drug substance, drug product, analytical, quality, regulatory, and clinical supply. The position involves crafting the CMC Development Plan, driving decisions, and ensuring operational execution aligns with strategy, risk, and value. The ideal candidate thrives at the intersection of science, operations, and governance, with a focus on accelerating patient impact.

Requirements

Bachelor's Degree with a minimum of 8-10 years of experience in the biopharmaceutical industry
Prior experience in a CMC leadership role
Demonstrated critical thinking capabilities with forward looking perspective.
Strong communication, leadership, and collaboration skills are required.
Solid understanding of drug development and clinic supply processes
Demonstrated ability to build, coordinate, and lead teams.
Strong interpersonal skills; proficient and able to influence others in spoken and written English.
Ability to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Nice To Haves

Prior experience as a liaison with corporate partners preferred.
High level of proficiency in MS Office software including Word, Excel, Outlook, Visio, Project, and PowerPoint.
Knowledge of MS Project Server a plus

Responsibilities

Own CMC leadership for a defined asset from Candidate Selection through First Approval, ensuring strategy, execution, and risk management align to program objectives.
Own the development of the integrated CMC Development Plan, setting clear priorities and team goals for timely submissions, clinical starts, and approval readiness.
Translate strategy into actionable operational plans, define critical paths, and drive delivery across drug substance, drug product, analytical, quality, regulatory CMC, and clinical supply.
Identify key interdependencies across execution teams, proactively manage risks and issues, and advance according to enterprise governance to protect timelines and quality.
Serve as the sole CMC point of contact to enterprise Global Product/Medicine Teams and internal governance bodies, providing transparent updates and securing decisions.
Facilitate timely, data-driven decisions across all CMC functions, ensuring clarity of responsibilities, deliverables, and success criteria.
Build positive relationships across the organization and with senior leaders; communicate succinctly, align team members, and create momentum behind the plan.
Prioritize and encourage a diverse, high-performing team; foster accountability, continuous improvement, and a patient-centered approach.