About the Company
Eli Lilly and Company is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. For more than a century, we have stayed true to a core set of values — excellence, integrity, and respect for people — while striving to meet the world’s growing health needs. We’re committed to creating an environment where employees can thrive professionally and personally.
Job Description
We are seeking a highly skilled and motivated HPLC Chemist – Chromatography Specialist to join our analytical development team in Fort Wayne, Indiana. The successful candidate will be responsible for performing complex analytical testing using High-Performance Liquid Chromatography (HPLC) to support research and development, quality control, and manufacturing operations. This role demands meticulous attention to detail, a strong understanding of chromatographic principles, and the ability to troubleshoot and optimize methods.
Key Responsibilities
- Execute routine and non-routine analytical testing using HPLC and other chromatography techniques (e.g., GC, LC-MS) to analyze raw materials, in-process samples, and finished products.
- Develop, validate, and transfer robust analytical methods for drug substances and drug products in accordance with ICH guidelines and regulatory requirements.
- Perform system suitability, calibration, and routine maintenance of HPLC instruments to ensure optimal performance and data integrity.
- Analyze and interpret complex chromatographic data, identify trends, and prepare comprehensive reports and presentations.
- Troubleshoot chromatographic methods and instrumentation issues, implement corrective actions, and document resolutions.
- Collaborate cross-functionally with R&D, Quality Assurance, and Manufacturing teams to support project timelines and objectives.
- Ensure all laboratory activities comply with cGMP, GLP, and company safety standards.
- Contribute to continuous improvement initiatives for analytical processes and laboratory efficiency.
Required Skills
- Extensive hands-on experience with HPLC systems and software (e.g., Empower, Chromeleon).
- Strong understanding of chromatography theory and principles.
- Experience in analytical method development, validation, and transfer.
- Proficiency in data analysis and interpretation.
- Knowledge of cGMP/GLP regulations and ICH guidelines.
- Excellent problem-solving and troubleshooting abilities.
- Effective written and verbal communication skills.
Preferred Qualifications
- Master's degree in Chemistry, Analytical Chemistry, Biochemistry, or a related scientific field.
- Experience with other analytical techniques such as GC, LC-MS, Karl Fischer, dissolution testing.
- Familiarity with regulatory submissions and compliance in the pharmaceutical industry.
- Prior experience working in a pharmaceutical or biotechnology manufacturing environment.
Perks & Benefits
- Comprehensive health, dental, and vision insurance.
- 401(k) retirement plan with company match.
- Paid time off and company holidays.
- Tuition reimbursement and professional development opportunities.
- Employee assistance programs.
- On-site fitness centers and wellness programs.
- Generous parental leave.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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