Senior​/Principal Scientist - QC

Role Summary

The Senior/Principal Scientist - QC provides technical leadership and expertise in the development, implementation, and maintenance of Quality Control laboratory systems at the Lilly Lebanon API site during startup, implementation, and day-to-day operations. The role involves accurate testing of routine and non-routine lab samples in accordance with GMP and safety guidelines, second-person data verification, participation in root cause investigations and equipment qualifications, and supporting quality system improvements.

The position may also provide technical support to QC operations as part of the organization’s forensic testing arm.

• Verify (SPV) analytical data of other analysts within the lab as requested
• Accurately and safely perform analytical test methods or related support activities per procedures or protocols
• Review data for conformity to procedures, standards, and protocols; recognize aberrant data in real time
• Perform data entry and review own work for accuracy in accordance with GMP requirements
• Initiate and participate in Root Cause Investigations for deviations
• Troubleshoot equipment and methods as required
• Experience in particle isolation, FTIR, ICP-OES, Microscopy preferred
• Assist in improvement of quality systems by creating or revising workflows and data collection systems
• Follow standards for Continuous Improvement (CCI/Lean) and lead departmental or site improvement initiatives
• Participate in laboratory projects following Lean OpEx standards
• Contribute to development of PQEs; review SOPs for executable as written
• Share technical information and best practices within plant sites or groups
• Write protocols for non-routine testing or validation; develop equipment qualification protocols
• Perform routine equipment calibrations or maintenance; ensure safety standards
• Notify management as required by procedures; initiate change controls and deviations
• Train and mentor others; develop training materials

• Required:
  
  Bachelor’s degree (4-year) in a science field related to the lab (e.g., Chemistry, Biology, Microbiology)
• Required:
  
  3+ years experience within a cGMP laboratory environment
• Preferred:
  Ability to work in a lab environment with appropriate PPE and safety considerations
• Preferred:
  Strong math and documentation skills
• Preferred:
  Strong oral and written communication and interpersonal skills
• Preferred:
  Proficiency with LIMS, CDS, Microsoft Office Suite
• Preferred:
  Experience with cGMP deviation and change control processes
• Preferred:
  Experience with FTIR, ICP-OES, Microscopy, Particle Isolation

• Laboratory data review and interpretation
• Root cause investigation and problem solving
• Laboratory information systems (LIMS) and data management
• Analytical method development and non-routine testing
• Equipment qualification and calibration
• Documentation, compliance, and SOP adherence

• Bachelor’s degree in a science field related to the lab (e.g., Chemistry, Biology, Microbiology)

• Must complete applicable Learning Plan for Scientist-QC
• Tasks may require repetitive motion and standing for long periods
• Must be able to lift at least 5 liters of liquid
• Role may require 24-hour operations with shifts covering days, nights, and weekends
• Overtime or weekend work may be required as necessary