Chemist – QC – IAPI
Eli Lilly and Company
Summary
The Chemist – QC – IAPI performs accurate and timely testing of routine lab samples in accordance with appropriate GMP and safety guidelines. The Chemist – QC - IAPI also participates in second person verification (SPV) of analytical data, laboratory investigations, equipment calibrations and maintenance by executing well-defined protocols and procedures. The Chemist – QC - IAPI identifies and communicates opportunities for improvement within the lab.
Job description
The Chemist – QC – IAPI reviews and interprets results for their laboratory. The Chemist – QC – IAPI initiates analytical method re-evaluations based on data generated within the laboratory including knowledge acquired from monitoring the Proven Important Factors (PIFs) monitored within the laboratory data. They may perform non-routine laboratory work in support of those projects.
The Chemist – QC – IAPI utilizes technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and complete thorough investigations of atypical data and results. Outcomes of these activities including results, conclusions, and action plans and/or technical documents.
The position is responsible for technical mentoring of laboratory staff and sharing technical information and best practices within the work group and across plant sites. The Chemist – QC – IAPI participates and influences the technical agenda of the plant or corporation.
Key Objectives/Deliverables
Sample Analysis and Reporting
- Accurately and safely perform analytical test methods or related support activities as per procedures or protocols and reviews that results conform to standards
- Perform data entry and reviews own work for accuracy in accordance with laboratory procedures, standards, and GMP requirements
- Recognizes when a deviation from procedures, etc. has occurred and initiates an investigation
- Verify (SPV) analytical data of other analysts within the lab as required
Continuous Improvement Initiatives
- Identifies and communicates opportunities for improvement initiatives in daily work activities
- Troubleshoot equipment and methods as required
Lab Operations
- Training and mentoring others within lab, where applicable
- Executes notification to management when required by procedures or standards
- Understand the scientific principles required for manufacturing and testing of intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
- Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess analytical vs. process variability and capability.
- Provide technical support to non-routine (e.g., deviation) investigations
- Support production floor operations through change proposals, investigations, and deviation root cause analysis.
- Maintain and improve quality systems including method remediation.
- Participate in self-assessments and regulatory agency inspections.
- Ensure internal and external quality and supply commitments are met.
This position will be on a 12 hr rotating shift supporting a 24/7 365 operation. The hours for this role are 5:45am-6pm and will be on a 3-2-2-3 schedule.
Requirements
- Minimum bachelor's degree in science or 2 years experience in a chemistry based laboratory
- Bachelor's in chemistry, analytical chemistry, or biochemistry preferred
- 2 years experience in analytical chemistry laboratory work in a GMP-regulated environment
- Ability to apply advanced techniques and tackle moderately complex technical challenges
- Must be able to lift at least 5 liters of liquid
- Must be authorized to work in the United States on a full-time basis
- Demonstrated strong problem solving and analytical thinking skills
- Understanding of statistical tools and analysis
- Excellent interpersonal skills and networking skills
- Experience in QA, QC, Manufacturing, Tech Services, or Regulatory Affairs
- Demonstrated strong written and verbal communications skills
- Strong attention to detail
- Ability to organize and prioritize multiple tasks
Benefits
- Company Bonus
- 401(k) Matching
- Pension
- Vacation Benefits
- Medical, Dental & Vision
- Prescription Drug Benefits
- Flexible Spending Accounts
- Life Insurance
- Death Benefits
- Leave Benefits
- Employee Assistance Program
- Fitness Benefits
- Employee Clubs and Activities
Company overview
Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.