Analytical Technical Steward Peptides and Oligonucleotides

Role Summary

The Analytical Technical Steward in API External Manufacturing Quality Control is a technical role responsible for ensuring analytical testing of products at multiple sites meets Lilly and external requirements, with data reviews, investigations, and cross-functional collaboration to maintain robust analytical control strategies for the molecules supported.

Responsibilities

• Technical review, interpretation, and release of data including data released from CM, stability, process validation, and reference standard characterization.
• Lead or perform in-depth investigations for out-of-spec results and aberrant data; conduct root cause analysis and implement preventive actions.
• Develop investigational testing protocols and perform testing as required.
• Contribute to APR, tech transfer, and process validation as required.
• Communicate effectively in writing and orally within the API EM organization and with external customers and partners.
• Participate in internal/external audits as needed.
• Develop and execute quality plan projects.
• Coordinate testing needs across sites for batch release, stability, process validation, or single batch verification testing.
• Perform method assessments and identify deficiencies or areas for improvement.
• Ensure method validation packages for marketed products align with regulatory expectations and monographs; update packages as needed.
• Participate in method validations to meet regulatory requirements or support method changes.
• Review analytical test method packages; approve test method protocols; approve new or modified test methods.
• Provide laboratory support for marketed products (method development, validation, implementation, training/transfer, change controls, regulatory submissions).
• Support technical agenda projects including new technologies in QC labs and methodologies improvements.
• Improve QC assays, reduce variability, optimize methods, and develop new ones.
• Own local and global method change control; oversee reference standard evaluations; select packaging materials; advise on characterization protocols for corporate reference standards; approve protocols prior to lab testing of candidate materials.
• Review reference standard profiles and data integrity; manage method transfers to contract manufacturers; oversee transfers to CM labs or third-party QC labs.
• Monograph review and implementation; ensure consistency across laboratories running the same methods; manage multiple projects.

Qualifications

• Bachelor degree in a science field related to the lab (e.g., Chemistry, Biochemistry, Pharmacy) or equivalent experience.
• 5+ years of industry-related GMP laboratory experience; large molecule, peptide, and/or oligonucleotide experience strongly preferred.

Skills

• Proficiency in complex analytical techniques including chromatographic (HPLC, GC), spectroscopic, bioassay, compendial, and LC-MS analysis.
• Ability to operate in a lab environment with appropriate PPE and safety guidelines.
• Strong knowledge of compliance requirements and regulatory expectations; ability to coach and influence others.
• Accurate analytical skills with strong problem-solving abilities; experience with root cause analysis is preferred.
• Excellent written and oral communication; strong interpersonal skills.
• Ability to work in cross-functional teams and across networks; strong analytical capabilities.
• Experience with method qualification, validation, and transfer; QC support for contract manufacturers of starting materials, intermediates, and APIs (large molecule, peptide, oligonucleotide).
• GMP or CS mode analytical equipment maintenance and computer systems validation (CSV); experience with corporate reference standards management and testing/reporting from contract manufacturers.

Education

• Bachelor degree (4-year college) in a science field related to the lab (e.g., Chemistry, Biochemistry, Pharmacy) or equivalent experience.

Additional Requirements

• Must complete applicable Learning Plan requirements.
• Tasks may require repetitive motion and standing for long periods.
• Must be able to lift at least 5 liters of liquid.
• May require up to ~20% travel overseas; passport required.
• Role located in Indianapolis, IN.