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 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.

Position Brand Description:

The Chemist – QC – IAPI is the data steward for analytical data generated in their laboratory. They have responsibility to provide the technical support needed to ensure reliable and compliant manufacture of bulk drug substance to predetermined global quality standards.

The Chemist – QC – IAPI reviews and interprets results for their laboratory. 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:

• 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 including the preparation as required of relevant technical documents, such as: Change Controls, Regulatory Submissions, Deviations, Validation Protocols, Tickets, Procedures, PFDs, Periodic Quality Evaluations, etc.
• 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.
• Manage the review and retention of cGMP documents.
• Must follow data integrity practices and procedures. (ALCOA+ principles).

Basic Requirements:

• Bachelor’s Degree in a science related field or 7+ years of demonstrated relevant experience in a GMP laboratory.

• 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.
• Experience and knowledge of cGMP requirements.

Education Requirements:

• Minimum of a Bachelor’s Degree.

Other Information:

• Must complete applicable Learning Plan.
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
• Overtime or on-call hours may be required in order to meet business needs.
• Unless approved by leadership, Chemist-QC-IAPI is considered an on-site position.
• Must adhere to policies and guidelines outlined in the employee handbook and Red Book.

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.

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

$65,250 - $169,400

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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