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.

Organization Overview: 

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). The CT Active Pharmaceutical Ingredient (API) team is responsible for the oversight of CT manufacturing executed internally within the K360 pilot plant located in Indianapolis at LTCN and at partner sites across the globe.

 

Responsibilities:

As the QA Associate PRD API, you will provide quality and compliance support for API manufacturinginitially supporting external BRD (Bioproduct Research and Development) collaboration partners worldwidewith potential long-term to support SMDD (Synthetic Molecule Design & Development) as needed based on Lilly portfolio demands.

• Provide secondary Quality support to API Manufacturing at collaboration partners across the globe, particularly as it relates to decisions associated with impact to the quality of products via processing questions in partnership with Lilly technical personnel, change controls, and deviations.• Execute qualification and Quality oversight of API Collaboration Partner manufacturing which includes building and maintaining relationships and performing person-in-plant visits.• Perform pre- and post- review of batch production records utilized for manufacturing.• Primarily review and approve collaboration partner Change Controls and Deviation investigations. Assess the impact of change controls and events on the product and regulatory commitments. Potential for authoring internal change controls exists.• Ensure appropriate execution of Quality Systems both internal (Lilly) and external (collaboration partner) 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.• Ensure inspection readiness through compliance auditing, site self-assessments, GMP education, monitoring, establishing and enhancing Quality systems.• Identify opportunities for and participate in continuous improvement.

 

Basic Requirements:  

• Bachelor’s degree in biochemistry, engineering, pharmacy, or science-related field• 5+ years’ experience supporting cGMP API/drug substance manufacturing (QA, TSMS, operations, engineering, auditing, etc.)•2+ years’ experience supporting cGMP manufacturing in a QA role that includes performing batch record review

 

Additional Skills/Preferences:

 

• Previous batch disposition QA experience • Previous experience writing Quality agreements with external partners• Previous experience working with external partners or demonstrated ability to confidently and comfortably communicate and challenge viewpoint outside of direct team• Proven ability to influence without direct authority both internally and externally• Demonstrated deep technical knowledge• Experience with computer systems (i.e., TrackWise, Veeva, SAP, Excel, PowerPoint, PowerBI)

 

Additional Information:

• On-site position located in Indianapolis (LTCN) with expectation of 3 days per week on-site but flexibility given to the days.  After hour support may be required depending on CP/business need• Occasional travel (