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Quality Control Lab Chemist

Durham, North Carolina

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Req ID R-4201 Title Quality Control Lab Chemist City Durham State / Province North Carolina Country United States

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 39,000 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:

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 39,000 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. #WeAreLilly

Position Brand Description:

Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina.  The QC Lab 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 method through method development, optimization, validation, transfer, or verification.  The successful candidate will work in partnership with Global  QCL, Global Facilities Delivery (GFD) organization, Global IT, Robotics, and the local site management to insure the laboratory is capable of all area monitoring, utilities, materials receipt, in-process, release, and stability testing tested required for routine site support. 

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.
  • Support initial recruiting and help build capability in Lab operations.
  • Additional responsibilities include:
    • Ensuring 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.
    • Insure methods, procedures and practices adhere to Lilly Global Quality Standards and regulatory requirements, including data integrity.
    • Supporting Lean Lab and efficient lab operations
    • Mentoring technicians and chemists in the QC Laboratory
  • 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.

Minimum Requirements:

  • Previous Lab IT / Automation experience including work with LIMS, LES, Environmental lab systems, enterprise chromatography systems and standalone COTS testing instrument IT systems.
  • Ability to manage and contribute to multiple concurrent project activities and adapt to changes in priorities.
  • Demonstrated creativity, analytical thinking, and the ability to troubleshoot and solve problems
  • Experience with statistics and data analysis software, especially data visualization
  • Working effectively with a cross functional group.
  • Understanding of compliance requirements and regulatory expectations for lab systems.
  • Excellent written and oral communication skills and ability to collaborate and interact with management, scientists, engineering and IT personnel.
  • Ability to work 8 hour days – Monday through Friday
  • Ability to work overtime as required.

Additional Preferences:

  • Previous experience with Lilly deviation and change control processes
  • Experience with Empower, SmartLab, Darwin, and MODA
  • Work with monoclonal antibody (Mab) product testing
  • Strong technical aptitude and ability to train and mentor others

Education Requirements:

  • Bachelor or Masters of Science in Science or engineering discipline with a minimum of 5 years industry experience working in a GMP QC Lab with additional experience in method transfer, optimization, validation, and remediation in GMP analytical testing laboratories.

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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-4201.

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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