Senior Analytical Technical Specialist
2 days ago
We are seeking a highly skilled and experienced Senior Analytical Technical Specialist to join our Global Quality Laboratories team at Eli Lilly. As a key member of our team, you will be responsible for developing and implementing analytical methods for marketed products, ensuring compliance with regulatory expectations, and collaborating with cross-functional teams to drive quality and excellence.
Key Responsibilities- Develop and implement analytical methods for marketed products, including laboratory work, training, and transfer of new methods to labs.
- Ensure method validation packages are consistent with current regulatory expectations, evaluating existing data and taking actions to update packages or provide additional data as needed.
- Execute method development work and implementation of method improvements for marketed products, including regulatory submissions.
- Develop method assessments for marketed product control strategies and address 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 and 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.
- PhD Degree in Chemistry, Biochemistry, or related field and a minimum of 3 years' experience in the pharma/biotech industry, or BS/MS in Chemistry, Biochemistry, or related field and a minimum of 5 years' experience in the pharma/biotech industry.
- 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.
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 are committed to helping individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs.
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