Senior Principal Chemist
5 days ago
We are seeking a highly skilled and experienced Senior Principal Chemist to join our team at Eli Lilly. As a key member of our Global Quality Laboratories division, you will play a critical role in ensuring the quality and integrity of our products.
Key Responsibilities- Transfer analytical methods for marketed products to third-party manufacturers or other quality control laboratories.
- Ensure that method validation packages are consistent with current regulatory expectations, including 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 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/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 pharmaceutical/biotechnology industry, or
- BS/MS in Chemistry, Biochemistry, or related field and a minimum of 5 years' experience in the pharmaceutical/biotechnology 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.
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