Analytical Technical Steward Peptides and Oligonucleotides

The Analytical Technical Steward in API External Manufacturing Quality Control focuses on ensuring that analytical testing of products at multiple sites meets Lilly and external requirements and follows predetermined standards.

We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, and more active lives.

• Technical review, interpretation, and release of data including data released from CM, stability, process validation, and reference standard characterization.
• Utilize technical skills to lead or perform in-depth investigations for out-of-specification results and aberrant data. Draw conclusions, perform root cause analysis investigations, and recommend solutions to prevent recurrence.
• Develop investigational testing protocols and perform testing as required.
• Contribute to APR, tech transfer, and process validation as required.
• Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners.
• Participate in internal/external audits as needed.
• Develop and ensure execution of quality plan projects.
• Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing.
• Perform method assessments, noting deficiencies and areas for improvement.
• Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs, taking actions to update packages as needed.
• Participate in method validations according to Global Quality Standards to bring methods up to current regulatory requirements or to provide additional data to support method changes.
• Review analytical test method packages.
• Approve test method protocols and new or altered test methods.
• Provide laboratory support, including method development, validation, and implementation of method improvements for marketed products.
• Support technical agenda projects, including implementation of new technologies in QC labs and improvements to existing methodologies.
• Improve assays in QC by reducing variability, optimizing methods, and developing new methods.
• Own local and global method change control.
• Oversee reference standard evaluations per Global Quality Standards.
• Select appropriate packaging materials.
• Consult in the preparation of the characterization protocol for corporate reference standards.
• Approve the characterization protocol before initiating laboratory testing of candidate materials for corporate reference standards.
• Participate in the review of the reference standard profile and associated documentation for data integrity.
• Transfer methods to contract manufacturers.
• Oversee transfer of analytical methods for marketed products to CM laboratories or designated third-party QC labs.
• Review and implement monographs.
• Ensure consistent practices between laboratories running the same methods.
• Effectively manage multiple projects.

• Bachelor's degree (4-year college) in a science field related to the lab (e.g., Chemistry, Biochemistry, Pharmacy).
• 5+ years of industry-related experience in pharmaceuticals in a GMP lab (Large Molecule, Peptide, and/or Oligonucleotide strongly preferred).
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role.

• Proficiency in complex laboratory analysis including chromatographic (HPLC and GC), spectroscopic, bioassay, compendial, and LC-MS.
• Ability to work in a lab environment, wearing appropriate PPE and following safety guidelines.
• Deep understanding of compliance requirements and regulatory expectations with demonstrated capability to coach and influence.
• Demonstrated accuracy and proficiency in analytical skills.
• Strong problem-solving skills and proven training in Root Cause Analysis methodology.
• Strong oral and written communication skills demonstrated through documentation and presentations.
• Strong interpersonal interaction skills.
• Ability to work in cross-functional teams and across networks.
• Experience with method qualification, validation, and transfer.
• Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs, including Large Molecule, Peptide, and/or Oligonucleotide.
• Proficiency in establishing and maintaining GMP or CS mode analytical equipment, including computer systems validation (CSV).
• Proven ability to support maintenance of Corporate Reference Standards, manage testing and reporting of results from contract manufacturers.

• Must complete applicable Learning Plan requirements.
• Tasks may require repetitive motion and standing for long periods of time.
• Must be able to lift at least 5 liters of liquid.
• May be required to provide 24-hour cell phone coverage.
• May require up to approximately 20% of…