Lilly Research Scientist in Bioproduct Analytical Development in Bengaluru, India
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.
Overview of the organization
Bioproduct Research and Development (BRD) is an innovation-focused organization within Eli Lilly and Company. BRD is involved in key activities for the development of parenteral biologics drug substance and drug products including synthetic organic drug products from pre-clinical phases through commercialization. Our dynamic department is made up of molecular and cell biologists, purification and process engineers, pharmaceutical scientists, analytical chemists, and engineers. We strive to identify, develop, and apply groundbreaking technologies to deliver maximum benefit to our patients. BRD delivers on these responsibilities by recognizing that diverse talent and cultures are vital to bring the next generation of life changing medicines to patients. BRD Analytical is a flexible, cross-functionally integrated, and capabilities driven team within BRD committed to providing state of the art measurement sciences to guide product and process understanding leading to optimized control strategies. Our mission is to elucidate understanding at molecular level, define critical quality attributes, integration of CMC knowledge, establish new platforms and technologies, and achieve regulatory acceptance to commercialize life changing medicines.
Main Purpose and Objectives of Position
As part of a multi-disciplinary team in BRD Analytical, a successful candidate would be an individual contributor on multiple project teams. Responsibilities would include performing activities supporting an integrated analytical control strategy for a variety of active pharmaceutical ingredients, dosage forms, reference materials, and placebos. Included in these responsibilities would be oversight of analytical methods from development to validation, identifying solutions to complex technical issues, and comprehensive documentation to advance the portfolio.
Understands and complies with corporate, divisional, and departmental procedures, including GMP, safety, and other regulations.
Efficiently and effectively manage aspects of analytical control strategies of active pharmaceutical ingredients and drug products, as well as reference materials and placebos, for multiple projects in various phases of development.
Demonstrates comprehensive knowledge of various techniques to enable troubleshooting and problem solving (e.g., HPLC, CE, ELISA, qPCR, Bioassay, Karl Fischer, UV, compendial and parenteral tests such as particulates).
Oversight of development and verification / qualification / validation of methods to support in-process, release, characterization, and stability testing of active pharmaceutical ingredient and drug product.
Openly shares technical knowledge and key learning while establishing relationships with key business partners.
Ability to be flexible within the workday and effective at various forms of communication to enable participation in global team interactions.
Effectively guide and oversee external work at collaboration partners.
Demonstrates proficiency at data reporting, interpretation, and trending (e.g., Empower chromatography software and electronic laboratory notebooks).
Demonstrates good documentation skills with regard to raw data recording and authoring of technical documents (e.g., technical reports, data integrity reviews, and submission components).
Maintains awareness of analytical science advances, as well as pharmaceutical industry and regulatory trends.
P4 - BS/MS in analytical or related field with relevant pharmaceutical experience; alternatively, skills commensurate with a BS/MS chemist.
R1/R2 – Ph.D. in analytical, or related field; alternatively, skills commensurate with a Ph.D. chemist.
Previous pharmaceutical industry experience (preferably 5+ years) required.
Chemistry experience with knowledge of one or more of the following, as appropriate: separation sciences, biophysical/ biochemical characterization, and bioanalytical sciences.
Experience in large molecules and analytical development recommended.
Capable of designing experiments and interpreting results independently.
Ability to troubleshoot problems and identify solutions.
Effective oral and written communication skills, self-management, task planning, and organization.
Excellent general computer skills (MS Excel, Internet Explorer, PowerPoint, MS-Word, JMP) and the ability to compile, summarize, and present information to diverse groups.
Must be able to work productively in an interdisciplinary team environment as well as to influence and partner with individuals outside of a formal reporting relationship towards realization of team goals.
Experience with the drug development process, including knowledge of regulatory compliance issues.
Fundamental knowledge of cGMP/GLP compliance requirements.
0-15% is typical
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At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!