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.
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.
Basic Qualifications:- Education Level: Minimum bachelor's degree in science or 2 years experience in a chemistry based labatory. (bachelor's in chemistry, analytical chemistry, or biochemistry preferred)
- Experience: 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
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1
Additional Preferences:- 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
- Additional Information:
- Must complete applicable Learning Plan
- Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE
- May be required to provide on call support
Additional Information:- This position will be on a 12 hr rotating shift supporting a 24/7 365 opperation. The hours for this role are 5:45am-6pm and will be on a 3-2-2-3 schedule.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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