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\xe2\x80\x99re looking for people who are determined to make life better for people around the world.AdPath/Level:R5/R6Organization 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.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\xe2\x80\x99s portfolio.Extractables are potential analytes that are extracted from the container/closure system under exaggerated conditions of time and temperature. Leachables are a subset of extractables that migrate from the container closure system (CCS) into drug substance (DS) or finished drug product (DP) under conditions of intended use or accelerated storage conditions.Large molecule drug substance and drug product as well as small molecule parenteral drug products usually have liquid presentations and have a high potential for leachables to migrate to the DS/DP. Regulatory agencies require that all final containers and closures shall be clean and free of surface solids, leachable contaminants and other materials that will hasten the deterioration of the product or otherwise render it less suitable for the intended use. Other guidance provided in USP and ICH requires the assurance that no leachables from the process contacting materials and CCS will impact the safety of the DS and DP. Assessments for extractable and leachable for some manufacturing components, delivery devices, and all container closure systems are required for submissions to health authorities (BLA, CTD etc.).The successful candidate of this position will support extractable and leachable studies for pharmaceutical development and manufacturing through working closely with external testing laboratories and Lilly internal functional areas.Key Responsibilities:

• Attend cross-functional meetings with project leads to understand timelines necessary for E&L studies.
• Work with Development and Manufacturing to make sure requesting DS and DP samples and control samples from relevant studies.
• Document proposal requests and review quotes for studies with external suppliers.
• Interface with Procurement to request Purchase Orders.
• Review extractables study lab protocols to support the Lilly platform.
• Review leachables study lab protocols to support molecule-specific DS and DP.
• Review molecule specific methods developed for the leachables studies for qualification / validation criteria.
• Review the strategy documents for the molecule specific leachables study for the DS and DP Container Closure Systems
• Work with Global Packaging engineers in DDCS to obtain samples and information needed for studies.
• Coordinate shipping of samples to external suppliers for E&L studies.
• Organize and help review extractables and leachables study reports provided by external study suppliers prior to completion and then once approved upload to Lilly QDocs.
• Provide data integrity review of extractable and leachables study result summaries / reports to share will Lilly toxicologists for assessments.
• Perform data integrity review of the regulatory submission sections relevant to E&L assessments. .

Educational Requirements:

• BS or MS in Analytical Chemistry, Organic Chemistry, or related field.

Experience Requirements:

• Knowledge or hands-on experience in Analytical Chemistry, especially those in sample preparation and analysis of organic compounds and related species using various analytical techniques, e.g. GC-MS, GC-FID, LC-PAD-MS, ICP-MS, HPLC-CAD/ELSD, ion-chromatography, TOC, NMR, etc.
• 7-10 years of relevant experience in Extractable Leachables assessment or other relevant analytical development areas
• Experience in identification of organic compounds and degradants using advance mass spectrometry techniques (e.g., high-resolution tandem mass spectrometry).
• Knowledge of relevant regulatory guidance (e.g., USP, ICH) on analytical methods and extractable and leachable studies.
• Familiarity with Microsoft Office Tools. Skills in Power BI or computer programming languages and database tools is desirable.
• Excellent written and oral communication skills.
• Excellent critical thinking capability and attention to details.
• Highly organized and efficient in executing complex tasks under tight timeline.
• Highly motivated to learn new knowledge and skills.
• Ability to collaborate effectively with others in a fast-paced multifunctional team environment.

Additional Information:

• Location-Bengaluru India

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively \xe2\x80\x9cLilly\xe2\x80\x9d) 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.#WeAreLilly

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