Sr./Principal Scientist - QC

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 an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly’s largest investment in manufacturing capacity and 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 Scientist-QC is part of the Lilly Lebanon API Quality Control team and provides technical leadership and expertise in the development, implementation, and maintenance of Quality Control laboratory systems to the Lilly Lebanon API site throughout the start-up, implementation, and day to day operations.

The Scientist-QC performs accurate and timely testing of routine and some non-routine lab samples in accordance with appropriate GMP and safety guidelines.  The Scientist completes second person verification of other’s results.  The Scientist also participates in laboratory root cause investigations, equipment evaluations and qualifications, and some quality system improvement initiatives by executing well-defined protocols and procedures.  The Scientist shares technical information and best practice within plant sites or group.

In addition, the Scientist-QC will provide technical support to QC operations as part of the organization’s off-hours support strategy.

Key Objectives/Deliverables:

    Sample Analysis and Reporting

• Verify (SPV) analytical data of other analysts within the lab as requested
• Accurately and safely perform analytical test methods or related support activities as per procedures or protocols.  Uses technical knowledge in the review and interpretation of data for conformances to procedures, standards and protocols and/or real-time recognition of aberrant data and results.
• Perform data entry and reviews own work for accuracy in accordance with laboratory procedures, standards and GMP requirements

    Problem Solving

• Recognizes when a deviation from protocols, procedures, etc. has occurred and initiates and participates in a Root Cause Investigation
• Performs investigations for deviations
• Troubleshoot equipment and methods as required

    Continuous Improvement Initiatives

• Assist in improvement of quality systems by creating or revising workflows and other lab data collection systems
• Follow Lilly standards for CCI/Lean and support/lead departmental or site continuous improvement initiatives
• Participate and/or lead laboratory projects in adherence to Lean OpEx standards
• Contributes to development of PQEs
• Reviews SOPs for executable as written
• Shares technical information and best practice within plant sites or group

    Lab Operations

• Write protocols for non-routine testing or validation with appropriate guidance
• Develop equipment qualification protocols with appropriate guidance
• Perform routine equipment calibrations or maintenance
• Comply with and implement safety standards
• Execute notification to management when required by procedures or standards
• Initiate change controls and deviations
• Train and mentor others. 
• Develop training materials

Basic Requirements:

• Bachelor’s degree (4-yr College) in a science field related to the lab (e.g., Biology or Microbiology)
• 1+ year of experience in a GMP QC Lab environment
• Previous experience with testing supporting various microbiological testing methods such as microbial enumeration tests (e.g., bioburden), growth promotion, and pour plate assays preferred

Additional Preferences

• Proficiency with computer systems LIMS, CDS, Microsoft Office Suite, etc.
• Ability to work in a lab environment, including wearing appropriate PPE and other safety required equipment a