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. Our employees around the world 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. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
The analytical technical steward role within the Global Quality Laboratories (GQL) division will include a combination of laboratory activities and method transfer activities. Laboratory work may include method optimization, reagent qualifications, or other experimental determinations. Method transfer may include hands on analyst training, and authoring/reviewing documentation to move the molecule from the Development phase to the Commercial phase. The qualified individual will be expected to collaborate with third parties, development laboratories, and international testing laboratories. The qualified individual will also be expected to communicate results and processes effectively in presentation and written reports, and to participate in cross-functional teams actively and cooperatively.
Responsibilities:
- Transfer analytical methods for marketed products to Third Party manufacturers or other QC laboratories.
- Ensure that method validation packages are consistent with current regulatory expectations. This includes evaluating existing method validation data and taking actions to facilitate updating packages or providing additional data to support method changes/laboratory practice changes, as needed.
- Execute method development work and implementation of method improvements for marketed products (including laboratory work, training/transfer of new methods to labs, implementation of new technologies/improve existing technologies change controls, and regulatory submissions).
- Develop method assessments for marketed product control strategies and addresses deficiencies and areas for improvement identified in the assessments.
- Understand basic development, manufacturing, and regulatory processes, and maintain awareness of analytical and pharmaceutical industry trends.
- Balance needs/workload for multiple projects simultaneously.
- Establish relationships with Development or Third parties to enable development, optimization, or validation of analytical methods.
- Interact with development laboratories for training and utilization of new technologies.
- Provide updates to supervision regarding progress and issues.
- Conduct reference standard evaluations including consultation on the protocol, review of profile and associated documentation.
- Ensure compliance with applicable quality, environmental, and safety expectations.
Basic Requirements:
* PhD Degree in Chemistry, Biochemistry, or related field and a minimum of 3 years’ experience in pharma/biotech industry,
or
* BS/MS in Chemistry, Biochemistry, or related field and a minimum of 5 years’ experience in pharma/biotech industry.
Additional Preferences:
* Extensive hands-on experience with analytical techniques, analyses, and instrumentation, related to large and small molecules.
* Proven oral and written communication skills.
* Understanding of GMP quality systems.
* Knowledge about FDA/EMA regulations on method validation.
* Ability to influence diverse groups and effectively manage relationships,
* Demonstrated ability to teach, train, and supervise other scientists.
Additional Information:
*This position is banded across multiple levels, and the job title received upon hire might not be the posting title. Business titles are dependent upon employee level.
*This position is based in Indianapolis, IN and requires onsite presence the majority of the time. This is not a remote position.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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