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.

Organization Overview

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

Responsibilities

The APR Coordinator is responsible for the technical evaluation of, preparation of and/or contribution to the Indianapolis Parenteral Manufacturing APRs (Annual Product Reviews), ARs (Annual Reviews), YBPRs (Yearly Biologic Product Reports), raw material annual assessments, and monthly quality metrics. As part of the periodic assessments, the APR Coordinator reviews the product and process data to identify and escalate trends which may have an adverse impact on the safety and quality of the product. The role will regularly interact with product stewards, cross-functional APR contributors, Regulatory personnel, and various members of leadership to assure APR reporting occurs with technical rigor, per quality requirements, and on time. The APR Coordinator will also participate on multi-site teams to influence improvements to the iAPR tool and share best practices. Additionally, the APR Coordinator is responsible for APR program ownership to assure local procedures and tools comply with regulatory requirements and corporate standards.

Key Objectives / Deliverables:

• Understand the scientific principles required for the manufacturing and testing of parenteral drug products to aid the in identification of data signals which may impact the safety and quality of the products.
• Develop and maintain the annual APR schedule for all IPM products and materials in alignment with FDA committed due dates.
• Initiate, prepare, assess, and drive to completion IPM periodic reviews including but not limited to APRs (Annual Product Reviews), ARs (Annual Reviews), YBPRs (Yearly Biologic Product Reports) and raw material annual assessments.
• Create control charts of in-process and finished product data and evaluate adverse trends
• Ensure that clear, accurate, and timely APR actions are assigned to contributors.
• Manage the completion of APR assigned actions.
• Assess and report applicable plant metrics per business requirements.
• Collaborate with APR Coordinators from other manufacturing sites to benchmark and share best practices.
• Identify and influence improvements to the iAPR tool. Participate in the improvement initiatives as needed.
• Complete periodic reviews of APR related procedures, tools, and forms to assure compliance with regulatory requirements and corporate standards.
• Complete thorough data integrity and second person verification activities for the content of the periodic assessment reports.
• Provide technical support for audit requests related to APR reports and data.
• Provide technical support for APR related investigations.
• Own change controls, as needed, to support TS/MS initiatives.

Basic Qualifications:

Bachelor's Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field OR 5+ years of pharmaceutical experience with a strong scientific base and technical writing skills.

Additional Preferences:

• Experience in pharmaceutical manufacturing environment in any of the following associated disciplines: TSMS, Production, Quality Assurance, Quality Control, or Engineering. Strong system knowledge of iAPR tool and source data systems (ex. DARWIN, PMX, SAP, RIM, Trackwise)
• Effective technical writing skills
• Strong compliance mindset
• Ability to influence regulatory, business, or technical issues within the site and function
• Responsible for maintaining a safe work environment
• Interactions with regulators, customers, and other stakeholders on business issues in support of internal and external agency audits
• Proficiency in delivering complex tasks and/or tasks that are cross-functional
• Strong analytical and quantitative problem-solving skills
• Demonstrated ability to learn & apply technical/scientific knowledge
• Ability to communicate and influence effectively across functional groups and stakeholders
• Ability to gain support for ideas or positions on difficult issues
• Ability to influence diverse groups
• Demonstrated establishment of key relationships with those outside of business area
• Enthusiasm for changes, team spirit and flexibility

Professional Certification/License: N/A

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 ( [email protected] ) 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 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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at [email protected].

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-28861.

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.