Senior Manager, European Commercial Manufacturing

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 unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 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.

Position Overview:

The Senior Manager Commercial Manufacturing position is responsible for supporting the European radiopharmaceutical commercial manufacturing operations. The commercial manufacturing network consists of multiple contract manufacturing organization facilities located in select geographic locations to provide just-in-time delivery of radiotracers to patients.

This position liaises internally (CMCD, QA, Supply Chain, Regulatory) and externally (contract manufacturers) to ensure commercial radiotracers are safely and reliably manufactured with quality always.

Responsibilities:

• Manage contract manufacturing organization (CMO) sites to ensure the just-in-time supply of commercial and clinical trial radiopharmaceutical drug products
• Ensure CMO compliance with internal and external radiopharmaceutical product manufacturing and testing procedures and specifications.
• Ensure CMO compliance with applicable Marketing Authorizations.
• Ensure adherence to master service, dose supply, and quality agreements.
• Coordinate review of CMO deviation investigations and follow up to ensure CAPA completion.
• Identify technical problems or deficiencies at CMO sites and collaborate with site to find solutions
• Lead the internal joint process teams to maintain operations
• Work as a liaison between manufacturing, material management, clinical supply, quality, and regulatory to coordinate resources and deliver on objectives
• Collaborate with professional peers and leadership across internal and external teams
• Assist in the expansion of radiopharmaceutical drug product capacity at existing and new CMOs
• Triage and relay potential manufacturing issues to management.
• Drive process improvements and lead projects to support process improvements at the CMOs.
• Track manufacturing and testing results and issues.

Basic Qualifications:

• Graduated pharmacist or bachelor’s degree in scientific field.
• At least 5 years of pharmaceutical industry experience or equivalent experience.

Additional Skills/Preferences:

• Experience in radiopharmaceutical manufacture, testing and supply chain management
• Project Management experience
• CMO sponsor oversight management
• Strong computer skills (e.g. Excel, Word, Project)
• Ability to operate across organizational, functional and geographic boundaries.
• Fluent in English
• Intermediate proficiency in second language

Additional Information:

• 10-25% Travel. Primarily within Europe and occasional travel to US offices
• 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

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 ( E-Mail schreiben ) 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.

Lilly 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.

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