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 35,000 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.
The Synthetic Molecule Design and Development (SMDD) organization has an exciting opportunity for a scientist to join our process development organization. You will be part of a diverse team of analytical chemists, engineers and formulators delivering product and process understanding across a broad range of pharmaceutical manufacturing platforms. In addition, you will be responsible for carrying out basic and applied research as an individual contributor in the development and implementation of advanced process analytical technology (PAT) and modeling/optimization tools focused on real-time process monitoring and control applied to continuous and/or batch drug product manufacturing processes.
Top candidates for this position will be encouraged to:
Design, develop, and implement analytical methodologies for real-time characterization and monitoring of drug product processes and platforms.
Identify opportunities to create new insights that will inform drug product formulation, process, and other risk-based decisions.
Apply creative solutions to address instrument design, process integration, and data handling challenges.
Show strength in optical/vibrational spectroscopy. Apply chemometric and first principles modeling techniques to support process development teams and, as appropriate, real-time release testing strategies.
The ideal candidate will have experience using multiple spectroscopic based analytical techniques (IR, NIR, Raman, UV, etc.) and their application to drug product development and manufacturing. The candidate must demonstrate computer proficiency with the ability to navigate multiple instrument control software and data analysis environments, capably integrate data and implement innovative data analysis workflows, have strong technical problem-solving ability, and have an internal motivation to work independently and achieve efficient, high quality results in a fast-paced environment.
Engage with scientists across Eli Lilly’s Development and Manufacturing and Quality organizations to develop a deep understanding of new initiatives and improve existing scientific processes.
Conceive innovative solutions employing cutting-edge PAT technologies and applying industrial trends in analytical chemistry, chemical engineering, and continuous manufacturing.
Identify and utilize new scientific concepts, strong problem-solving skills, and be self-motivated to achieve quality results in a fast-paced environment.
Author technical documents that capture hypotheses, experimental designs, details, and findings. Review source data entries, reports and protocols to assure compliance with current guidance principles.
Proactively identify risks, then conceive and clearly communicate novel mitigation opportunities to development team members.
Basic Qualifications:Additional Preferences:
Experience with spectroscopy-based process monitoring tools (such as NIR and Raman, etc.) including phase-appropriate method development, validation, and data interpretation applying chemometrics, multivariate modeling, and other data manipulation tools.
Extensive technical knowledge of analytical instrument hardware and control software from different vendors.
Instrument engineering experience including design, development, or modification of analytical platforms.
Experience with continuous and/or batch drug product manufacturing processes.
General knowledge of process monitoring and control with system automation/integration.
Knowledge and understanding of regulatory and quality implications of a real-time monitoring in a regulated environment.
Demonstrated ability to rapidly learn and apply technical knowledge to meet changing project needs.
Flexibility to adjust priorities over time to meet organizational and scientific goals.
Demonstrated leadership capabilities, especially in a team environment.
Ability to balance multiple activities, prioritize and handle ambiguity.
Actively seek opportunities to present and publish scientific contributions.
Location: Indianapolis, IN
Potential exposure to chemicals, allergens, and loud noises.
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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).