Lilly PRD API QA Representative in Indianapolis, Indiana
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.
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.
Product Research and Development (PRD) quality assurance (QA) supports the delivery of the Lilly pipeline by providing oversight of the manufacturing, packaging, and distribution of the medicines needed for clinical trials (CT). As a QA Representative, in the active pharmaceutical ingredient (API) team, you will be responsible for the oversight of CT API manufacturing. This manufacturing is executed internally within the K360 clinical trial pilot plant located in Indianapolis at LTCN and at partner sites across the globe.
As a PRD API QA representative, you will be part of a team that provides oversight and executes batch release activities for API used in clinical trials. The API includes biologics (monoclonal antibodies, gene therapies, etc.) and chemically synthesized molecules (traditional small molecules, peptides, siRNA, etc.). API is manufactured internally in the K360 clinical trial pilot plant, by intracompany partners (e.g. Kinsale, Branchburg, IAPI), and externally by collaboration partners (CPs). For internal manufacturing, your oversight includes participating in production team meetings and spending time on the floor with operations personnel. For both internal and external manufacturing, you will also be responsible for approving master production records, reviewing executed batch records, and executing batch release activities. Oversight of external partners also includes partner qualification and person-in-plant activities. Additional specific responsibilities include:
Participate in day-to-day activities and decisions, including observation and change impact assessments) associated with the manufacturing of CT API.
Ensure appropriate execution of Quality Systems to sustain compliance with regulatory requirements and good manufacturing practices.
Support and / or evaluate the disposition of batches, including management and review of GMP documentation, analytical results, and regulatory commitments.
Assess the impact of change controls and events on the product and regulatory commitments
Identify opportunities for and participate in continuous improvement (with respect to both productivity and compliance)
Influence cross-functional manufacturing groups to maintain and continuously improve the quality system.
Provide support for internal and regulatory site inspections.
Maintain qualification of external partners.
Bachelor’s degree in Science, Engineering, or related field
Previous experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.)
Previous experience supporting cGMP API/drug substance manufacturing
Demonstrated strong oral and written communication skills
Demonstrated interpersonal skills and the ability to work as part of a team
Proven ability to envision and oversee implementation of continuous improvements
Previous QA experience
Proficient with data collection/analysis systems (e.g. Power Apps, Power Automate, SQL, Python, Tableau, PowerBI, etc.)
This position flexibly supports manufacturing activities in Indianapolis (LTCN).
Occasional travel (<10%) will be required for collaboration partner oversight, training, conferences, etc.
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@example.com.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!