Sr. Principal - Scientist - (QC - Analytical Equipment Support)

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 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

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Houston, TX.  This facility is intended to provide APIs for current and future products, including new modalities.  This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. 
 

Position Description:  

The Analytical Equipment Support Group (AESG) Scientist provides technical leadership and expertise for analytical instrumentation. We are seeking a skilled scientist with a strong engineering focus to join our team. The ideal candidate will be responsible for maintaining advanced analytical equipment and helping to ensure the accuracy and reliability of data gathered from these instruments. This role involves collaborating with cross-functional teams, troubleshooting equipment issues, and contributing to the development of engineering solutions to a variety of advanced QC analytical equipment. The scientist will also complete technical review of protocols and reports. They will also share technical information and best practice within the group. 

Key Objectives/Deliverables:  

• Manage and maintain advanced analytical equipment, ensuring optimal performance and reliability. 

• Collaborate with cross-functional teams to integrate analytical findings into practical applications. 

• Troubleshoot and resolve equipment issues, performing routine maintenance, calibration and qualification activities.  

• Design and implement engineering improvements to enhance equipment performance and efficiency. 

• Stay updated with the latest advancements in analytical equipment, methodologies, and engineering practices. 

• Ensure compliance with all relevant regulations and standards. 

• Manage comprehensive equipment life cycle.  

• Represent Lilly Houston in Global Lab Equipment Network.  

• Adhere to global quality standards related to computer systems.  

• Identify systemic issues affecting analytical testing in QC.  

• Research and recommend new technologies.  

• Serve as a technical mentor for Scientists and Technicians within and outside QC.  

• Work with both internal and external organizations in instrument selection, usage, and troubleshooting.  

• Coordinate with lab SMEs for procurement, set-up, and validation of lab equipment  

• Create maintenance work instructions and establish engineering controls.  

• Manage the drafting and review of cGMP documents.  

• Manage/Develop maintenance strategies and author qualification protocols. 

• Participate in self-assessments and regulatory inspections/audits.  

• Provide technical review and Second Person Verification (SPV).  

• Maintain and improve quality systems.  

• Provide technical support to non-routine (e.g., observations) investigations including the preparation as required of relevant technical documents, such as: Change Controls, Analytical Investigations, Validation Protocols, Procedures and Quality System Management Review, etc.  

Basic Requirements:  

• Bachelor’s degree (chemistry or engineering is preferred) and 1+ year of experience in a GMP regulated environment OR 
• 10+ years of experience managing maintenance, analytical equipment, or similar role in a GMP re