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Organization Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Analytical Technical Steward in API External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams, as well as APLOT. The Analytical Technical Steward works closely with development counterparts and GQL to ensure robust analytical control strategies are established for molecules they support.

Responsibilities:

• Technical review, interpretation, and release of data including data released from CM, stability, process validation, and reference standard characterization.
• Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence.
• 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.
• Performs method assessments, with deficiencies and areas for improvement noted within the assessments.
• Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed.
• Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices).
• Review of analytical test method packages
• Approval of test method protocols
• Approval of new test methods or changes or deletions to existing test methods
• Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions).
• Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies.
• Improve assays in QC. These improvements include variability reduction, method optimization, and new method development.
• Local and Global Method Change Control Ownership
• Oversight of reference standard evaluations per Global Quality Standards
• Selection of appropriate packaging materials
• Consult in the preparation of the characterization protocol for corporate reference standards
• Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards
• Participate in the review of the reference standard profile and associated documentation for data integrity
• Method transfers to Contract Manufacturers
• Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs.
• Monograph review and implementation
• Ensures consistent practices between laboratories running the same methods
• Effective management of multiple projects

Basic Requirements:

• Bachelor 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, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills/Preferences:

• Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, bioassay, compendial and LC-MS.
• Ability to work in a lab environment, including 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
• Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology
• Strong oral and written communication skills demonstrated through documentation and presentations
• Demonstrated strong interpersonal interaction skills.
• Ability to work in cross functional teams as well as across networks.
• Demonstrated analytical skills.
• Demonstrated experience with method qualification, validation, and transfer.
• Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include Large Molecule, Peptide, and/or Oligonucleotides.
• Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV).
• Proven ability to support maintenance of Corporate Reference Standards, and manage testing and reporting of results from contract manufacturers.

Additional Information:

• 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 travel overseas, requiring a passport.
• Role is located in Indianapolis, IN

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$65,250 - $169,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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