Sr. 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.

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.

Responsibilities

The Sr. Chemist performs accurate and timely testing of routine lab samples in accordance with appropriate GMP and safety guidelines, to support site production and stability requirements.  The Sr. Chemist will perform laboratory testing techniques including but not limited to UV-Vis, HPLC, device testing and perform compendial analysis (for example: pH, Color, Clarity, Osmolality).  The Sr. Chemist will review and interpret results and will perform second person verification (SPV) of analytical data.  The Sr. Chemist utilizes technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and assist in resolving laboratory investigations of atypical data and results. 

Key Objectives/Deliverables:

• 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.
• Perform routine laboratory analyses.
• Review and interpret data and document results of analyses and conclusions accurately and thoroughly in accordance with GMP and local guidelines.
• Utilizes technical skills to assist with in-depth investigations associated with out-of-specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence.
• Assist with development of investigational testing protocols and perform testing as required.
• Author SOPs and training documentation.
• Execute inspection readiness activities in the QC laboratories.
• Interact effectively with auditors and business partners.
• Training and mentoring lab personnel.
• Supporting Lean Lab and efficient lab operations.
• Comply with and assist with implementing safety standards.

Basic Qualifications

• Education:
  • Bachelor or Masters in a science or engineering discipline (Chemistry, Biology, Mechanical Engineering, Biomedical Engineering, etc.)
• Experience:
  • Minimum 3 years of demonstrated relevant experience in a GMP laboratory.
  • Previous experience with LC instruments, enterprise chromatography systems and standalone COTS testing instruments.

Additional Skills/ Preferences

• Experience with Empower and LabVantage LIMS.

• Demonstrated written and oral communication skills and ability to collaborate and interact with management, scientists, engineering, and IT personnel.
• Demonstrated problem-solving skills. Preferred training and experience in Root Cause Analysis methodology.
• Ability to manage and contribute to multiple concurrent project activities and adapt to changes in priorities.
• Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.

Additional Information

• Tasks may require repetitive motion and standing for long periods of time.
• 8-hour days – Monday through Friday.
• Minimal travel required.

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Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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