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.

Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe 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 Summary:

The Advisor, RLT QC will provide project leadership and technical direction within RLT, ensuring consistent practices between laboratories globally while driving harmonization between manufacturing and testing sites.  Tasked with identifying and implementing global/cross-functional assessments, improvements, and standardization, this individual will drive internal business process improvements across multiple RLT groups.

Responsibilities:

Utilize knowledge of quality system and regulatory requirements to influence appropriate validation experiments are conducted to sustain control strategy.Influence and/or implement process improvements locally and/or cross-functionally.Utilize data, information, and/or diverse experience in influencing business decisions with local and/or cross-functional impact.Share learnings/teach others about basic development, manufacturing, and regulatory processes, and maintain awareness of analytical and pharmaceutical industry trends.Perform non-routine analytical work, analyze data, and prepare appropriate documentation.Demonstrate proficiency in developing, investigating, optimizing, and/or validating analytical methods.Identify areas for improvement, propose, network, and implement potential solutions in multiple areas/topics.Identify and implement global/cross-functional assessments, improvements, standardization, and/or harmonization.Improve assays in QC; these improvements include variability reduction, method optimization, and method development.Mentor new team members as needed.Ensure compliance with applicable quality, environmental, and safety expectations.Work collaboratively with people in GQL to achieve departmental goals.Demonstrate independence in balancing workload for multiple projects simultaneously.Execute method development work and implementation of method improvements for marketed products. Examples may include laboratory work, training/transfer of new methods to labs, implementation of new technologies/improve existing technologies change controls, and regulatory submissions.Ensure method validation packages are consistent with current regulatory expectations. This includes evaluating existing method validation data and taking actions to facilitate updating packages or providing additional data to support method changes/laboratory practice changes, as needed.Develop method assessments for marketed product control strategies and addresses deficiencies and areas for improvement identified in the assessments.Establish relationships (e.g., Development or Third parties) to influence and ensure appropriate development, optimization, or validation of analytical methods.

Basic Requirements:

Bachelor’s degree in biology/chemistry, or related field5+ years of pharmaceutical manufacturing experience.Experience collaborating with Development or Third Parties to ensure a proper method is developed, optimized/validated, and ready for transfer.

Additional Preferences:

Experience conducting reference standard evaluations including consultation on the RS protocol, review of RS profile and associated documentation.Experience with spectroscopic techniques is desirable (for example, NIR, Raman, Fluorescence).Experience with multivariate/chemometric modeling is desirable (model development, validation, optimization, implementation, and model maintenance).Knowledge of various IT Tools / softwareBasic knowledge of printed packaging materials / processes.Demonstrated and current experience with multiple analytical techniques such as HPLC, LC-MS, GC-MS, FT-IR, NIR, Raman, ICP-OES, SEM-EDS, microscopy, etc.Experience with Deviation & Change Control Processes.Root Cause analysis experience.Experience with method transfers.

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

$121,500 - $198,000

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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