Senior/Principal, Scientist – QC Raw Materials

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.

Organization Overview:

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

Position Description:

The Senior/Principal Scientist – QC Raw Materials is an expert in incoming raw materials for the Quality Control (QC) team. They review and interpret data and are responsible for managing raw material lifecycle systems at the site. The Senior/Principal Scientist performs non-routine laboratory work to support validation and qualification of incoming raw materials, such as chemicals, excipients, and packaging components. Additionally, they serve as a technical expert for third-party work, equipment evaluation, and qualification. The role requires using advanced technical skills to identify continuous improvement opportunities and to lead investigations into deviations in raw material quality data or unexpected laboratory results.

The ideal candidate brings hands-on laboratory experience, strong analytical problem-solving abilities, and proven leadership in regulated environments. A thorough understanding of current Good Manufacturing Practices (cGMP) and a commitment to data integrity are essential for success in this role.

The position will support technical mentoring of laboratory staff and for sharing technical information and best practices within the work group and across plant sites. Leadership and cross-functional collaboration are key, as the role requires close partnership with manufacturing, quality assurance, and supply chain teams to ensure seamless integration of raw materials into production processes. The candidate will actively participate in the technical application of incoming raw materials for the manufacturing facility.

In addition, the Senior/Principal Scientist – QC may provide technical support to QC operations as part of the organization’s off-hours support strategy.

Key Objectives & Deliverables

• Lead the Quality Control design and startup of raw material qualification, lifecycle management, and control strategies for a greenfield GMP facility.
• Maintain 100% data integrity and traceability for all raw material testing records, supplier data, and technical justifications.
• Direct implementation of Raw Material support processes in Quality Control, ensuring the establishment and ongoing support of both new and existing site materials.
• Evaluate material risks, supply changes, and operational impacts by partnering with manufacturing, QC, QA, procurement, and supply chain teams.
• Own or lead investigations of material-related deviations, OOS/OOT events, and root cause analyses; develop and implement sustainable corrective and preventive actions.
• Author, review, and approve GMP documentation including change controls, technical assessments, protocols, reports, and procedures.
• Support supplier change notifications and conduct technical evaluations of material comparability and variability.
• Contribute to material control strategies and annual product review (APR) assessments.
• Act as QC Raw Materials subject matter expert for inspection readiness, regulatory commitments, and site audits.
• Ensure all raw material practices align with site and global quality standards and maintain ongoing inspection readiness.
• Mentor junior analysts to achieve competency milestones, fostering a culture of continuous improvement and professional growth.
• Develop and implement at least two new structured training modules annually to enhance analytical capability across the team.
• Support the creation and maintenance of standard operating procedures and knowledge-transfer resources.
• Act as a key liaison to ensure seamless communication between the QC laboratory and cross-functional departments—including Procurement, Manufacturing, and Regulatory Affairs—driving operational excellence.

Basic Requirements:

• Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related scientific discipline.
• Demonstrated experience supporting raw materials within a GMP manufacturing or quality environment.
• Strong scientific understanding of chemical and material‑related risks in pharmaceutical manufacturing.
• Proven experience leading investigations, technical assessments, and cross‑functional problem solving.

Additional Preferences

• Experience with supplier qualifications, second‑source strategies, and regulatory inspection support.
• Strong written and verbal communication skills with the ability to clearly document and defend technical decisions.
• Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic, spectroscopic and / or microbiological assays
• Deep understanding of compliance requirements and regulatory expectations.
• Demonstrated accuracy and proficiency in analytical skills
• Demonstrated strong problem - solving skills. Preferred training and demonstrated proficiency in Root Cause Analysis methodology
• Strong oral and written communication skills and demonstrated through documentation and presentation skills
• Demonstrated strong interpersonal interaction skills
• Ability to focus on continuous improvement
• Ability to work in a lab environment, including wearing appropriate PPE and other safety related equipment or considerations.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Other Information:

• Must complete applicable Learning Plan.
• Tasks may require repetitive motion and standing for long periods of time
• Day Shift - Monday through Friday
• Required to respond to operational issues off shift
• Minimal travel 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

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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