Principal Scientist - QC Chemistry

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:Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities, including Gene Therapy. Located in Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, and start up the facility for both clinical and commercial supply. The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.Position Description:The Principal Chemist is a technical role in the Quality Control Laboratory helping to ensure the manufacture of products to predetermined standards to meet both Lilly and external requirements by focusing on QC laboratory systems during installation, startup, and operation. This role is responsible for the planning, coordination, and execution of laboratory certification on all chemistry testing methods through method transfer, optimization, validation, or verification, as well as execution of the testing. The successful candidate will work in partnership with Global Quality Control Laboratories (QCL), Global Facilities Delivery (GFD), Global IT, Automation, and the local site management to ensure the laboratory is capable of receipt and testing of incoming materials, in-process, release, and stability gene therapy samples.Key Objectives/Deliverables:Perform testing, review, interpretation, and release of chemistry product testing data, using techniques such as HPLC, CE, CCIT, icIEF, Spectroscopy, and Compendial/Wet-Chemistry methods.Provide analytical support, project leadership, and/or technical direction, and perform laboratory analyses and data review as needed.Perform technical training and mentor analysts through formal process/program.Oversee and participate in the transfer of analytical methods, including setting strategic direction, authoring and reviewing method certification documentation, execution of laboratory testing, and investigation of observations.LIMS usage, implementation, and deployment support by providing method-specific guidance.Utilize technical skills to lead or perform in-depth investigations into out of spec results and aberrant data. Draw conclusions and perform root cause analysis investigations and recommend solutions to prevent reoccurrence. Develop investigational testing protocols and perform testing as required.Improve lab quality systems; develop content, review, and approve SOPs and training as necessary.Contribute to development and implementation of Global Lab Quality Standards.Comply with and implement safety standards.Provide technical oversight for Periodic Management Reviews.Help develop a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.Interact effectively with business partners and auditors to communicate and resolve issues and gain a clear and accurate understanding of each other’s requirements.Network with groups internal and external to Lilly to understand best practices, share knowledge, participate in technical planning, and to ensure customer needs are met.Help define and execute inspection readiness activities in the QC laboratories.Provide additional support to the lab as necessary, such as support with e-systems (MODA, NuGenesis), equipment management and connectivity, and data integrity initiatives.Minimum Requirements:Education

Bachelors (4-year) degree in a science field related to chemistry, microbiology, or biology.

Experience

4+ years of demonstrated relevant experience in a GMP Testing Laboratory.Demonstrated proficiency in chemistry including, but not limited to HPLC, CE, CCIT, icIEF, Spectroscopy, and Compendial/Wet-Chemistry methods.Strong oral and written communication skills and demonstrated through documentation and presentation skills.

Additional Preferences:Experience with large molecule and/or viral vector testing techniques.Demonstrated strong problem-solving skills. Preferred training and demonstrated proficiency in Root Cause Analysis methodology.Demonstrated strong interpersonal interaction skills.Ability to focus on continuous improvement.Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.Deep understanding of compliance requirements and regulatory expectations.

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