Eli Lilly and Company Hiring a Analytical Technical Steward-Peptides in Hyderabad, India – June, 2025

Eli Lilly and Company is hiring an analytical technical steward in API (Active Pharmaceutical Ingredient) in Hyderabad, India.

Job Information

In API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control, the Analytical Technical Steward is a technical role that assists in making sure that product analytical testing at various locations satisfies Lilly and external requirements and is carried out consistently in accordance with established standards. Up to four in-person site visits to the contract manufacturer each week, or more frequently as needed, will be necessary for this peptide-focused role. The Analytical Technical Steward leads the resolution of laboratory-related manufacturing issues by conducting in-depth problem solving, proactively identifying opportunities for continuous improvement, and conducting comprehensive investigations of aberrant data and results. The steward also reviews data released by contract manufacturers in accordance with API EM Risk Based Oversight Governance to ensure it meets expectations for internal integration and data integrity, reviews deviations for trends, and reviews and/or releases stability data. They might support this with non-routine lab work.

Responsibilities

1. Technical evaluation, interpretation, and data release, including stability, process validation, reference standard characterisation, and data released from CM (Contract Manufacturers).
2. Use technical expertise to direct or carry out comprehensive investigations for anomalous data and outcomes that don’t meet specifications. makes inferences, does root cause analysis research, and suggests fixes to stop recurrence.
3. Create protocols for investigative testing and carry out tests as needed.
4. Verify that method validation packages for marketed products adhere to compendial monographs and current regulatory requirements. This entails assessing the data from method validation that is currently available and taking steps to make package updates easier when necessary.
5. Participates in Global Quality Standards-based method validations (either to update techniques to meet current regulatory standards or to offer new data to support changes in practices or procedures).
6. Packages for analytical test methods are reviewed.
7. Protocols for test methods are approved.
8. Approving the addition of new test methods or the modification or removal of current test methods.

Qualifications

1. A bachelor’s degree in a laboratory-related science (such as chemistry, biochemistry, biology, or pharmacy) and a master’s degree are preferred, as at least ten years of pharmaceutical industry experience in a GMP lab.
2. Experience with either large molecules or peptide SPPS/LPPS synthesis is required.
3. Experience in comparability evaluations and characterisation tests is required.
4. Experience with NDA applications, laboratory section authorship, and/or review is required. It is preferred to have experience with both NDA and BLA.
5. Proven ability to perform sophisticated laboratory analyses, such as spectroscopy, KF, particle size, LOD, appearance, LCMS, GCMS, bioassay, compendial tests, chromatographic (both HPLC-RP, Normal Phase, SEC, and GC-HS), and more.
6. Capacity to operate in a laboratory setting, including donning the proper PPE and adhering to safety regulations.
7. thorough comprehension of regulatory expectations and compliance standards.
8. displayed precision and mastery of analytical abilities.
9. Strong problem-solving abilities were displayed. Recommended completion of the training and proven competence with the Root Cause Analysis methodology.

Application

For more details and application, visit Lilly’s official website or job listing.

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