Principal Scientist – Analytical Full-time

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, 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 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.
• The individual works as a contributor on one or more project teams working on small or large molecules.
• Lead to perform the activities to evaluate the stability of a variety of active pharmaceutical ingredients (API) and dosage forms to support clinical trials, development and support of paediatric, line extension and commercial products in the Lilly portfolio.
• Design, plan and manage the testing, data interpretation and release/disposition of raw materials and excipients that will be used in manufacturing.
• Technical expertise in developing analytical methods for oral and/or parenteral products.
• Understanding of the compendial method requirements and procedures for raw material, Drug substance and Drug products.
• Managing the testing, evaluating release and stability data and has technical expertise in several critical areas of an analytical including troubleshooting.
• Technical excellence in Method development, qualification/verification, validation, method transfer activities.
• Technical expertise 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.
• The individual has sounds technical expertise on analytical methods with at least 1 of following molecules and systems:
• Antibodies/bifunctional/fusion proteins/proteins
• Peptides/oligonucleotides/other genetic medicines
• Small molecules/other synthetic molecules
• Raw materials and packaging material testing

Other key responsibilities:

• Thorough understanding and adheres to all relevant job-related policies, including business, compliance, regulatory (cGMPs), quality, environmental, and safety expectations.
• Makes sound technical decisions, and proactively communicates these decisions with other scientists and management. Assumes ownership and showcases accountability by effectively managing project deliverables.
• Develop, establish and maintain strong professional relationships with partners / internal and external customer and key stakeholders across geographical locations.
• Authoring and DIR of regulatory documents following good documentation practice (e.g., Empower, NuGenesis, Signals (eLN)) and demonstrates proficiency in data review, analysis, reporting, interpretation, and trending.
• Authoring, reviewing and tracking of change controls and oversee other compliance requirements relevant to department projects. Use scientific expertise to conduct the laboratory investigations, addressing OOT/OOS/aberrant data, root cause analysis and CAPA implementation.
• Participate in inspection readiness activities and support regulatory inspections including internal and external audits as needed.
• Skills in Power BI, Python and database tools.

Educational Requirements:

• MS with 5-8 years of experience or BS with 7-10 years of experience in analytical department of a pharmaceutical organization developing API or DP for clinical or commercial use.

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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.