Chemist - Process Automation Technology Analytical Lead

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.

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN.  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 Lebanon manufacturing site, and the successful candidate will help to build the overall site readiness plan to enable a successful startup into GMP manufacturing operations. 

The Process Automation Technology (PAT) Analytical Lead role in Analytical Sciences/Quality Control Laboratories will be responsible for the technical oversight of the implementation and sustained performance of the analytical methods and systems in support of Process Automation across the Lebanon manufacturing facilities. The assets involved may be small molecules, peptides, therapeutic proteins, sRNAs, gene therapy and drug conjugates. These assets maybe pipeline or commercial.  The lifecycle management of existing technologies will be a further aspect of the role.  Given the increasing need for more in-depth molecule information and the increasing complexity of assets the identification of and implementation of new or improved technologies will be required.  As all the information generated will be used to support manufacturing objectives the active participation in cross functional teams will be required to understand manufacturing and regulatory requirements while also providing the analytical perspective to ensure overall success. 

Key Objectives/Deliverables:

• Understand the scientific principles for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
• Be capable of preparing relevant technical documents, such as:  technical reports, change controls, deviations/observations, validation protocols, summary reports, procedures, data integrity assessments, etc.
• Assist in improvement of quality systems by creating or revising worksheets and other PAT documentation systems.
• Accurately and safely performs analytical test methods or related support activities as per procedures or protocols, as needed. Uses technical knowledge in the review and interpretation of data for conformances to procedure, standards and protocols and/or real-time recognition of aberrant data and results.
• Authoring/Reviewing SOPs for executable as written.
• Comply with and implement safety standards.
• Train and mentor others. Develop training materials.
• May perform second person verification of others’ results/reports.
• May perform holistic review of process analytical data (i.e. PATrol, Data Integrity).
• May perform and contribute to performance monitoring and trending, as required.
• Partner with frontline representative(s), Quality Control, and process teams to meet PAT requirements.
• Troubleshoot equipment and methods as required.
• Maintain and improve quality systems.
• Participate in self-assessment and regulatory agency inspections.

Basic Requirements:

• Bachelor’s relevant scientific discipline such as Chemistry, Engineering, Biology, Microbiology, etc.
• 5+ years of deep technical knowledge and experience in applicable analytical equipment and applications such as chromatography (UHPLC, PATrols), Infrared Spectroscopy, and/or SoloVPE, etc.

Additional Preferences:

• Demonstrated strong problem solving and analytical thinking skills.
• Understanding of statistical tools and analysis.
• Excellent interpersonal skills and networking skills.
• Strong computer skills (DeltaV, JMP, Excel, PI, Empower).
• Ability to organize and prioritize multiple tasks.
• Demonstrated strong written and verbal communication skills.
• Relevant industrial experience in any of the following associated disciplines such as Protein/Peptide/Small Molecule Manufacturing, Method Development/Validation, and Quality Control is desirable.
• High-quality skills include teamwork, decision making, multi-tasking, ability to influence groups, written and oral communication skills, computer skills, statistical analysis, and problem solving.

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