Associate Director - CMC Development Program Management

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

The Avid group's mission is to discover, develop, and deliver diagnostic solutions that improve global health by accelerating the development of new medicines. Avid's diagnostic solutions aid in early diagnosis, monitor the treatment effect of therapeutics and help understand disease pathology better. Avid is leveraging the power of diagnostics to transform patient outcomes. Avid is committed to accelerating the next generation of diagnostic tools to understand and unlock the potential of emerging science, enable the discovery of new medicines, and advance care for patients with unmet needs.

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* Position Overview:

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* The Associate Director, CMC Development will be responsible for the execution of multiple radiopharmaceutical CMC development and manufacturing programs supporting various therapeutic areas within Lilly Avid. In this capacity, this role will drive the development of strategic technical plans while providing 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.

Key responsibilities will include developing, maintaining, and enforcing integrated program timelines, assigning and ensuring completion of action items, leading CMC team meetings, identifying and managing risk, and partnering closely with broader program stakeholders and leadership to ensure that program activities closely align with business goals. 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 role requires an experienced, proactive self-starter with a strong executive presence and superior organizational skills who is passionate about driving operational excellence within the CMC Development group.

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.

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* Required Qualifications:

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* + BS, MS, or PhD in chemistry, analytical chemistry, biochemistry, molecular biology, engineering, pharmaceutical sciences, or equivalent scientific discipline.

+ Minimum 7 years of CMC experience in the pharmaceutical industry including at least 5 years of direct experience leading cross-functional CMC projects or…