Sr. Principal Chemist - QC 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.
Company Overview: Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Concord, North Carolina. The Sr. Principal Chemist is a technical role in the Quality Control Laboratory helping to ensure the manufacture of products to predetermined standards to meet both Lilly and external requirements by focusing on QC laboratory systems during design, installation, startup, and operation. This role is responsible for the planning, coordination, and execution of laboratory certification on all testing methods through method development, optimization, validation, transfer, or verification. The successful candidate will work in partnership with Global Quality Control Laboratories (QCL), Global Facilities Delivery (GFD), Global IT, Automation, and the local site management to ensure the laboratory is capable of receipt and testing of incoming materials, in-process, release, and stability samples.
Key Objectives/Deliverables: Provide analytical support, project leadership, and/or technical direction, and perform laboratory analyses and data review as needed. Oversee and participate in the transfer of analytical methods for marketed products, including setting strategic direction, authoring and reviewing method certification documentation, execution of laboratory testing, and investigation of observations. Interact with Global Quality Labs and other commercial QC Labs to identify and adopt best practices for testing, documentation, and investigations. Ensure all aspects of safety are incorporated into the design and practices in the QC Lab, while maintaining a safe work environment, including supporting all HSE Corporate and Site Goals. Support Lean Lab and efficient lab operations. Help develop a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group. Network with other areas and externally to understand best practices, share knowledge, participate in technical planning, and to ensure customer needs are met. Help define and execute inspection readiness activities in the QC laboratories. Interact effectively with auditors and business partners. Support implementation of LIMS system. Education/Experience Requirements: Bachelor or Masters in a science or engineering discipline (Chemistry, Biology, Mechanical Engineering, Biomedical Engineering, etc.) Minimum of 7 years of demonstrated relevant experience in a GMP lab. Minimum Requirements: GMP Laboratory experience including familiarity with analytical testing, method transfer, and method validation. Previous experience with enterprise chromatography systems and standalone COTS testing instruments. Ability to manage and contribute to multiple concurrent project activities and adapt to changes in priorities. Experience with statistics and data analysis software, especially data visualization. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Additional Preferences: Experience with Empower and LabVantage LIMS. Strong technical aptitude and ability to train and mentor others. Understanding of compliance requirements and regulatory expectations. Working effectively with a cross functional group. Excellent written and oral communication skills and ability to collaborate and interact with management, scientists, engineering, and IT personnel. Ability to focus on continuous improvement. Other Information: Ability to work 8 hour days – Monday through Friday. Ability to work overtime as required. Limited travel may be required during project phase. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources for further assistance. Please note this email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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