Associate Director - CMC Development Program Management

Role Summary

Associate Director, CMC Development will be responsible for the execution of multiple radiopharmaceutical CMC development and manufacturing programs across Lilly Avid. The role will drive the development of strategic technical plans and provide operational leadership. Accordingly, this individual will lead one or more cross-functional matrix teams comprising Process Development, Analytical Sciences, Manufacturing, Quality, Supply Chain, R&D, Finance, and Regulatory to ensure delivery of CMC milestones for priority assets throughout clinical development. For each CMC development program under their direction, this individual will serve as the primary point of contact, cross-functional subject matter expert, and thought leader within the Lilly Avid organization. This is a hybrid position requiring a minimum of three days per week on-site at the Philadelphia office.

Responsibilities

• Serve as the CMC Lead for one or more development assets, ensuring integrated planning, execution, and governance across internal and external functions.
• Build and lead fit-for-purpose cross-functional CMC matrix teams, aligning timelines, deliverables, and risk mitigation strategies to ensure critical development milestones are met.
• Identify, evaluate, monitor, manage, and communicate risks and associated mitigation plans; ensure timely communication with senior management and across relevant functional areas.
• Support regulatory strategy development and health authority interactions related to CMC; Drive development and execution of CMC activities in support of IND, CTA and BNDA/MAA submissions.
• Partner closely with Development and Manufacturing Operations teams to oversee technical transfer, process validation, stability, and comparability planning.
• Maintain accountability for CMC program timelines, budget, resource allocation, and key deliverables.
• Serve as the primary interface between CMC and global program leadership, translating program strategy into executable operational plans; Represent the CMC function on Global Program Teams and other governance forums when required.
• Facilitate efficient decision-making and host formal staged readiness reviews wherever applicable.
• Support regulatory strategy development and health authority interactions as the CMC lead contributor.
• Maintain currency with US, European, Japanese, Chinese, and ICH regulations and industry standards.
• Present program updates, risks, and strategy to leadership and across the broader organization.
• Define standards of practice for CMC program leadership, encourage adaptation, and provide mentorship accordingly across the organization.
• Demonstrate a commitment to developing around Avid's core competencies: cultivates innovation, drives engagement, ensures accountability, plans and aligns, nimble learning, and manages complexity.

Qualifications

• Required: BS, MS, or PhD in chemistry, analytical chemistry, biochemistry, molecular biology, engineering, pharmaceutical sciences, or equivalent scientific discipline.
• Required: Minimum 7 years of CMC experience in the pharmaceutical industry including at least 5 years of direct experience leading cross-functional CMC projects or programs.
• Preferred: Deep understanding of process development, technical transfer, cGMP manufacturing, analytical development, release, quality control, and regulatory expectations for pharmaceutical products.
• Preferred: Direct experience with management of external partnerships.
• Preferred: Experience with radiopharmaceutical CMC development is highly desirable.
• Preferred: Proficient understanding of cGMPs as well as US, European, Japanese, Chinese, and ICH regulations and industry standards for pharmaceutical development.
• Preferred: Familiarity with Stage 1-3 process validation and pharmaceutical product lifecycle management.
• Preferred: Excellent interpersonal, verbal, and written communication skills with the ability to work with uncertainty and to resolve conflict in a constructive manner.
• Preferred: Capable of influencing at all levels and building high-quality presentation materials, slide decks, and documents for internal and external audiences.
• Preferred: Travel up to 10% of the time within the US and internationally, as needed.
• Preferred: Familiarity with project management tools such as MS Project, Smartsheet, Monday, Jira, etc.
• Preferred: Self-motivated and comfortable in a fast-paced, demanding, and dynamic work environment.
• Preferred: Proficiency in the Microsoft 365 environment.
• Preferred: Legally authorized to be employed in the United States; sponsorship for employment visa status is not anticipated for this position.