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.
Position Overview:
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.
Required Qualifications:
* 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 programs.
Desired Qualifications:
* Deep understanding of process development, technical transfer, cGMP manufacturing, analytical development, release, quality control, and regulatory expectations for pharmaceutical products.
* Direct experience with management of external partnerships.
* Experience with radiopharmaceutical CMC development is highly desirable
* Proficient understanding of cGMPs as well as US, European, Japanese, Chinese, and ICH regulations and industry standards for pharmaceutical development.
* Familiarity with Stage 1-3 process validation and pharmaceutical product lifecycle management.
* Excellent interpersonal, verbal, and written communication skills with the ability to work with uncertainty and to resolve conflict in a constructive manner.
* Capable of influencing at all levels and building high-quality presentation materials, slide decks, and documents for internal and external audiences.
* Ability to travel up to 10% of the time within the US and internationally, as needed.
* Familiarity with project management tools such as MS Project, Smartsheet, Monday, Jira, etc.
* Self-motivated and comfortable in a fast-paced, demanding, and dynamic work environment.
* Proficiency in the Microsoft 365 environment.
* Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this position.
Additional Information:
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process, please email Lilly Recruiting Compliance. Please note, this email address is intended for use only to request a disability accommodation, please email Lilly Recruiting Compliance for further assistance. Inquiries which are not requests for accommodations may not receive a response.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$126,000 - $184,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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