Job Description

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\xe2\x80\x99re looking for people who are determined to make life better for people around the world.

Bioproduct Research and Development (BRD) is an innovation-focused organization within Eli Lilly and Company. BRD is involved in key activities for the development of parenteral biologics drug substance and drug products including chemically-synthesized biomolecule drug products from pre-clinical phases through commercialization. Our dynamic department is made up of molecular and cell biologists, purification and process engineers, pharmaceutical scientists, analytical chemists, and engineers. We strive to identify, develop, and apply groundbreaking technologies to deliver maximum benefit to our patients. BRD delivers on these responsibilities by recognizing diverse talent and cultures are vital to bring the next generation of life changing medicines to patients. The BRD GMP pilot plant is a flexible, cross-functionally integrated, and capabilities driven team within BRD committed to providing a high quality and reliable clinical supply of large molecule assets in Lilly pipeline. Our mission is to manufacturing materials to support clinical trials, integration of CMC knowledge, establish new platforms and technologies, lead technology transfer to commercial facilities and achieve regulatory acceptance of life changing medicines for global supply.

As part of a multi-disciplinary team in BRD Analytical, the incumbent will provide oversight and support for GMP activities of clinical trial material manufacturing. Job responsibilities include consumable inventory management, campaign planning activities, operational efficiency projects and project management. These activities may include use of data and information in Trackwise, Veeva Vault and other systems.

• Understands and follows all relevant policies relating to this job including business, compliance, regulatory, quality, environmental, and safety expectations. May participate in the development and review of procedures, policies, and training materials associated with the area.
• Demonstrates understanding and experience with cGMP requirements

• Develops and maintains awareness and familiarity of Lilly quality systems, ICH guidelines and other global regulations and guidance documents.
• Understands the needs and restraints of operating in a regulated manufacturing environment to balance the needs of the business and compliance requirements.
• Demonstrates project management, documentation and communication skills

• Efficiently and effectively manages project deliverables to provide support for multiple projects in multiple phases of development.
• Generates, interprets, troubleshoots and effectively communicates (both in writing and orally) relevant information to management, team members, project leaders, and customers.
• Develops and maintains successful partnerships with other Lilly scientists, regulatory representatives, QA representatives and third-party collaboration partners
• Ensures the accuracy of the data/information entered into IT systems.
• Demonstrates understanding and experience with laboratory and stability systems and tools

• Demonstrates proficiency in performing basic operations in common informatics tools to maintain collaboration tools in SharePoint and Teams

Demonstrates capability and expertise in utilization of Trackwise to document events and changes; familiar with ServiceNow and quality docs

B.S. or M.S. in Chemistry, Pharmaceutics or related field and significant pharmaceutical industry experience.

For the above activities, an individual in this role requires:

• Fundamental knowledge of cGMP compliance requirements and pharmaceutical principles.
• Previous pharmaceutical industry experience (at least 3-5 years) required
• Good documentation skills and ability to author and/or review standards, guidelines, SOPs, templates, protocols, and other GMP documentation.
• Excellent general computer skills (MS Excel, PowerPoint, MS-Word, SharePoint, Teams) and the ability to compile, summarize and present information to diverse groups.
• Excellent communication skills and willingness to interact with manufacturing personnel, contractors and management.
• Ability to troubleshoot problems and identify solutions.
• Ability to influence and partner with individuals outside of a formal reporting relationship towards realization of team goals.

Customer-focused attitude

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively \xe2\x80\x9cLilly\xe2\x80\x9d) 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.

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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