Sr. Director - CMC Development - Eli Lilly and Company

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.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism

This position has overall responsibility for Avid’s global investigational medicinal product (IMP) manufacturing, IMP and commercial product precursor and reference standard contract manufacturing and provides leadership and direction to IMP Manufacturing Operations, and Supply Chain operations teams. The individual will provide expertise and leadership in the development and manufacturing of new radiopharmaceutical products working in a fast-paced, multi-disciplinary environment.

• Lead multidisciplinary cross functional team(s) to develop, manufacture, and supply novel PET radiopharmaceuticals, ensuring adherence to timelines, quality standards, and cost targets.
• Collaborate with cross-functional team leaders, including development, CMC regulatory, manufacturing, and supply chain teams, to ensure seamless execution of CMC strategies and activities.
• Lead and direct the establishment and operation of Avid’s just-in-time manufacturing of PET radiopharmaceutical investigational medicinal product (IMP) at contract manufacturing organizations (CMO) globally to ensure reliable and sufficient supply to Avid/Lilly clinical trials.
• Develop, implement, and execute upon supply chain strategy for materials needed for manufacturing of PET radiopharmaceuticals including precursors and reference standards.
• Ensure compliance with global GMP guidance and regulatory requirements, defined by FDA, EMA, PMDA, and other global health authorities, for CMC activities.
• Collaborate with global partners and external vendors to ensure timely and quality delivery of CMC activities.
• Drive continuous improvement initiatives to optimize processes, reduce costs, and improve efficiency in PET radiopharmaceutical development and manufacturing.
• Partner with key functions (e.g. Clinical Supply, Clinical Development, Clinical Operations, and Clinical Imaging Operations) in the planning and execution of a manufacturing strategy to meet clinical trial supply requirements.
• Manage the creation of, and lifecycle, relevant CMC documentation.
• Transition late phase products in identified regions to commercial operations team(s) following commercial approval of asset in region.
• Stay updated on industry trends, technological advancements, and regulatory changes related to radiopharmaceutical development and manufacturing and incorporate them into the CMC strategy.
• Mentor and develop team members, providing coaching and feedback to foster their professional growth and enhance their contribution to the company.
• Continuously monitor and track project progress, budget, and resource allocation, and provide regular updates to senior management.
• Lead other tasks / projects as assigned.

Basic Requirements:

• Bachelor’s degree or advanced degree (i.e., Masters, PhD ), in scientific or engineering related field.
• 5+ years of pharmaceutical or biotech industry related experience

Additional Skills/Preferences:

• Advanced degree in relevant scientific or engineering field
• PET drug experience preferred.
• Ability to lead and direct teams of scientists and operational staff in the successful execution of complex drug development and supply projects and programs.
• Advanced understanding of cGMPs and CMC regulatory requirements
• Ability to manage people and drive engagement among teams.
• Ability to adapt to change and be a nimble learner.
• Ability to ensure accountability of oneself and others.
• Ability to plan and align.
• Creative thinking and ability to cultivate innovation.
• Impeccable organizational skills
• Superior written and verbal communication skills and ability to work in a fast-paced environment.
• Exceptional problem-solving and decision-making skills, with the ability to integrate complex scientific information into drug development plans.
• Excellent computer skills (e.g. Word, Excel, PowerPoint, Teams)

Additional Information:

• Must be willing and able to travel within the USA and worldwide 20% of time.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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