Scientist - TS/MS Components

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$64,500 - $143,000

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 39,000 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.  #WeAreLilly 

The Component Scientist – TSMS is responsible for providing technical support of container closure systems (e.g. glass containers, elastomeric closures, seals) to achieve the reliable and compliant manufacture of parenteral drug product in the Indianapolis Parenteral Manufacturing site.   The role will regularly interact with manufacturing process support personnel and component vendors to share learning and ensure strategies are in line with technical, quality, and regulatory guidance, while supporting business expectations.  The component scientist will also participate in troubleshooting and driving continuous improvement as it relates to container closure systems. 

 

Responsibilities: 

• Understand the scientific principles required for manufacturing parenteral drug products, including the interaction container closure systems on the chemistry, equipment, aseptic processes, and device functionality. 

• Ensure that accurate instructions and technical documents describe the process as performed at Lilly and respective vendors 

• Evaluates the impact of changes at suppliers or the local site 

• Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability. 

• Understand, justify, and document the state of qualification of components with data that evaluate the capability of the manufacturing process to meet its stated purpose. 

• Prepare, review, approve, and provide technical support for preparation of relevant technical documents as required, such as change controls, regulatory submissions, deviation investigations, qualification protocols and summary reports, processing records, procedures, process flow documents, validation master plans, annual product reviews, etc. 

• Support and/or lead the development and implementation of process improvements to improve process control and/or productivity. 

• Participate in development and implementation of process improvements including capital expansions and technical projects. 

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