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IAPI QC Chemist-FDE

Indianapolis, Indiana

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Req ID R-11888 Title IAPI QC Chemist-FDE City Indianapolis State / Province Indiana Country United States

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Chemist – QC – IAPI- FDE

Company Overview:

Lilly was founded in 1876 by Colonel Eli Lilly, a man committed to creating high-quality medicines that met real needs in an era of unreliable elixirs peddled by questionable characters. His charge to the generations of employees who have followed was this: "Take what you find here and make it better and better." More than 140 years later, we remain committed to his vision through every aspect of our business and the people we serve starting with those who take our medicines, and extending to health care professionals, employees and the communities in which we live.

Position Brand Description:

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 Requirements:

  • Bachelor degree in a science related field
  • Experience and knowledge of cGMP requirements in API manufacturing

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

Education Requirements:

  • Minimum of a Bachelor’s Degree

Additional Information:

  • Must complete applicable Learning Plan
  • Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE
  • This position is for 12 hour Day shifts, on a 3-2-2-3 schedule
  • This position is not permanent. It is for a fixed term of 2 years up to a maximum of 4 years and includes a competitive benefit package

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-11888.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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