Chemist – QC – IAPI

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the global by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

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 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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$66,000 - $148,500

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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