Eli Lilly and Company · 12 hours ago
Associate Director - CMC Development Program Management
Philadelphia, PA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$126K/yr - $185K/yr
7+ years expEli Lilly and Company is a global healthcare leader committed to improving lives through innovative medicines. The Associate Director, CMC Development will lead cross-functional teams to execute radiopharmaceutical CMC development and manufacturing programs, ensuring alignment with business goals and regulatory requirements.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
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
Qualification
Required
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
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
Preferred
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
Benefits
Company bonus
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
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