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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 Indianapolis API site has a long legacy of operating with technical excellence while producing lifesaving medicines for many decades. We are currently executing a complex modernization and transformation effort across the site that includes a strong analytical agenda. We are seeking a talented individual that can provide technical leadership and analytical molecule stewardship.

The Chemist – Quality Control provides stewardship of the analytical control strategy. This position may assist with analytical control strategy development and will be responsible for method transfers and method certifications as appropriate.

Key Objectives/Deliverables** **:

+ Serve as Site Analytical Molecule Steward for IAPI Drug Substance and ensure alignment with global decisions and practices.

+ Ensure the analytical control strategy from raw materials through drug substance is technically sound, cost effective, compliant and sustainable for specific molecules.

+ Serve as and/or provide oversight of reference standards in a molecule technical expert role.

+ Advise on the troubleshooting and investigation of major analytical issues. Participate in Root Cause Investigations, as needed.

+ Advise on the analytical component of regulatory strategies for specific molecules.

+ Author and review regulatory submissions including question response and providing critical reagent supply for drug substance authorization and import testing

+ Design, develop and implement analytical characterization strategies that reduce or eliminate the need for pilot scale, commercial scale and/or clinical comparison studies.

+ Identify and support the implementation of new technologies/methods that offer significant advantages in cost reduction, compliance improvement or process control.

+ Implement training programs designed to improve the technical capabilities within the IAPI QC organization.

+ Support regulatory inspections as a Subject Matter Expert for assigned analytical control strategy.

Basic Requirements:

+ Bachelor's degree in a in a laboratory-related science field (e.g., chemistry, microbiology or biology)

+ Six years of relevant experience in a GMP lab.

Additional Preferences:

+ Proficiency with computer systems.

+ Demonstrated strong math and documentation skills.

+ Demonstrated superior oral and written communication and interpersonal interaction skills.

+ Demonstrated ability to identify and perform self-directed work

+ Experience with a broad range of analytical techniques applicable to proteins

+ Knowledge of ICH guidelines applicable to biotech drug substance

+ Strong statistical skills

Other Information

+ Onsite presence required

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), enAble (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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