Analytical Scientist

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: The Product Research and Development (PRD) organization strives to develop and deliver quality medicines to patients. The portfolio consists of 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. 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 PRD team that works closely with the PRD team in Indianapolis in enabling the delivery of Lilly’s portfolio. Responsibilities and Skillsets: The individual will be part of a multi-disciplinary team in synthetic molecule design and development (SMDD) and Bioproduct Research and Development (BRD) Analytical organizations that are critical teams within PRD. Work as a contributor on one or more project teams working on small or large molecules. Perform activities to evaluate the stability of a variety of active pharmaceutical ingredients (API) and dosage forms to support clinical trials, development and support of pediatric, line extension and commercial products in the Lilly portfolio. Assist in testing, evaluation and release/disposition of raw materials and excipients. Develop and execute analytical methods for oral and/or parenteral products. Knowledge of compendial method requirements and procedures related to raw material, drug substance and drug products. Support activities such as testing, evaluating release and stability data, and have technical skills in several critical areas of analytics including troubleshooting, method development, execution, qualification/verification, validation, and method transfer to manufacturing sites and third-party testing laboratories. Experience in handling various analytical techniques such as HPLC, GC, CE-SDS, SEC, ELISA, qPCR, DSC, Bioassay, Karl Fischer, UV, LC-MS, Dissolution, Disintegration, X-ray diffraction, etc. Experience in working on analytical methods with at least one of the following molecules and systems: Peptides/oligonucleotides/other genetic medicines, Small molecules/other synthetic molecules, Raw materials and packaging material testing. Other key responsibilities: Thorough understanding and adherence to all relevant job-related policies, including business, compliance, regulatory (cGMPs), quality, environmental, and safety expectations. Proactively communicate with other scientists and management. Assume ownership and showcase accountability by effectively managing project deliverables. Develop, establish and maintain strong professional relationships with partners/internal and external customers and key stakeholders across geographical locations. Author regulatory documents, following good documentation practices (e.g., Empower, NuGenesis, Signals (eLN)) and demonstrate proficiency in data integrity review, analysis, reporting and trending. Author and track the implementation of change controls. Use scientific expertise to conduct laboratory investigations, addressing OOT/OOS/aberrant data, root cause analysis and CAPA implementation. Support inspection readiness activities including internal and external audits as needed. Skills in Power BI, Python, and database tools. Educational Requirements: MS with 1-5 years of experience or BS with 3-5 years of experience in the analytical department of a pharmaceutical organization developing API or DP for clinical or commercial use. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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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