Job Description

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:

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, USA. Our 39,000 employees worldwide 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.


The Medicines Innovation Hub (MIH) strives to discover, develop, and deliver creative medicines to patients through the development and commercialization of insulins, small molecules, monoclonal antibodies, novel therapeutic proteins, peptides, oligonucleotide therapies and gene therapy systems. This organization is a multidisciplinary group that works collaboratively with therapeutic business units and manufacturing to deliver the incredibly exciting Lilly clinical portfolio to patients around the world. This group drives innovation in the process development and product design through the efficient combination of domain expertise coupled with lab experimentation, computational modelling, automation, data sciences, and data rich experimentation.


The Lilly Capability Centre India (LCCI) located in Bengaluru India is a strategic investment made by Lilly to attract top talent from the vibrant academic and professional environment in India and deploy them to develop and enable critical capabilities for Lilly. The LCCI group in India houses a MIH team that works closely with the MIH team in Indianapolis in enabling the delivery of Lilly's portfolio.




Works as an individual contributor on one or more project teams cross functionally within analytical. Job responsibilities include performing activities for the analysis of a variety of active pharmaceutical ingredients and dosage forms to evaluate stability and support clinical trial materials; testing raw materials and excipients; generation/review of release and stability data; qualification, verification, validation, and transfer of analytical methods and techniques to manufacturing sites and third party testing laboratories ensure consistency of analytical testing across sites as necessary (both internal and external laboratories) while meeting compliance requirements. Apply cGMP practices during execution of routine testing. Lead and/or provide input to investigations using scientific techniques to resolve laboratory related issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results.

Key Responsibilities:

• Awareness, understands, and follows all relevant policies relating to this job including business, compliance, regulatory (cGMPs), quality, environmental, and safety expectations. Makes sound technical decisions, and appropriately communicates these decisions to other scientists and management.
• Demonstrates technical excellence at performing, assessing, and troubleshooting multiple analytical methods. Displays comprehensive knowledge of instrument set-up, operation, and troubleshooting (e.g., HPLC, CE, ELISA, qPCR, Bioassay, Karl Fischer, UV, compendial and parenteral tests - particulates).
• Openly shares technical knowledge and key learning.
• Efficiently and effectively manages project deliverables to provide support for multiple projects at multiple phases.
• Establishes and maintains key relationships within BR&D and Testing Labs.
• Identifies internal and external customer requirements and develops solutions to meet customer needs.
• Demonstrates proficiency at data review, analysis, reporting, interpretation, and trending (e.g., Empower, NuGenesis (eLN)) including batch release, stability, and method installation data.
• Demonstrates good documentation skills with regard to raw data recording and authoring of documents.
• Participates in investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent recurrence. Utilize technical writing strategies to ensure content is clear, concise, and complete.
• Participate in inspection readiness activities and support regulatory inspections. Participate in internal/external audits as needed.
• Author and track the implementation of change controls, and all other compliance requirements relevant to department projects.
• Use scientific expertise to assist with troubleshooting, laboratory investigations, OOT/OOS/aberrant data, and problem resolution. Participates in the root cause analysis and improvement of processes with technical and non-technical solutions that help to improve efficiencies within the department and prevent reoccurrence of deviations. Develop investigational testing protocols in support of analytical investigations and performs/oversees testing as required.
• Subject Matter Expert in instrumentation including installation, operation, and performance qualifications of instrumentation. SME in methods and troubleshooting.

Educational Requirements:

• BS/MS in analytical sciences, or equivalent pharmaceutical degree with at least 3 years relevant experience in Analytical field.

Experience Requirements:

For the above activities, an individual in this role requires:

• Fundamental knowledge of cGMP compliance requirements and regulatory expectations.
• Good documentation skills and ability to author and/or review standards, GMP guidelines, SOPs, templates, protocols, and other documentation.
• Excellent general computer skills (MS Excel, Internet Explorer, PowerPoint, MS-Word, JMP) and the ability to compile, summarize and present information to diverse groups.
• Familiarity with Microsoft Office Tools. Skills in Power BI, Python and database tools are nice to have.
• Ability to troubleshoot problems and identify solutions.
• Customer-focused attitude.
• Experience with a variety of root cause methodologies.
• Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment internally and with external partners.
• Demonstrated learning agility, and ability to think creatively, try new ideas and apply learnings and strong problem-solving skills.
• Highly flexible, adapting to changes in priorities, requirements, and processes.
• Demonstrate proficiency in complex laboratory analysis including, but not limited to chromatographic, spectroscopic, immunoassay, DNA, and/or microbiological assays.
• Ability to work in a lab environment and following safety guidelines.


Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.


Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


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