Principal Microbiologist

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.

Lilly is a fortune 500 company in operation for over 140 years creating high-quality medicines for our patients while living our company values of Integrity, Excellence, and Respect for People in everything that we do.

Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Concord North Carolina.  This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.  The Quality Control Laboratory assures patients worldwide of safe and efficacious drug and device products, through effective execution of product testing.

A Principal Microbiologist demonstrates strong technical writing in support of analytical investigations, laboratory deviations, laboratory protocols, and associated reports. The Principal Microbiologist will have strong understanding of laboratory testing techniques including but not limited to Bioburden Membrane Filtration, Endotoxin (RFC Method), Sterility, Growth Promotion, Particulates, Container Closure Integrity (CCI) and Microbial Identification. The Principal Microbiologist will support continuous improvement projects and laboratory deliverables to support site production and stability requirements. As needed, the principal will review and interpret results and will perform second person verification (SPV) of analytical data.  The Principal Microbiologist utilizes technical skills to perform in-depth problem solving and assist in resolving laboratory investigations of atypical data and results. 

Key Objectives/Deliverables:

• Accurately and safely perform timely testing of routine and non-routine lab samples in accordance with appropriate GMP and safety guidelines.
• Accurately record data in reports or LIMS in accordance with laboratory procedures, standards, and GMP requirements.
• Recognizes deviations from procedures, methods, etc. and initiates an investigation as required.
• Demonstration of strong technical writing skills to support report investigations, protocols and reports.
• Verify (SPV) analytical data generated by other analysts within the lab as required.
• Adhere to all Environmental, Health, and Safety standards.
• Identify and communicate opportunities for improvement initiatives in daily work activities.
• Troubleshoot equipment and methods as required.
• Support lean lab and 5S initiatives.
• Provide technical support for non-routine (e.g., deviation) investigations.
• Maintain inventory of all supplies and consumables for the laboratory.

Requirements (Education, Experience, Training):

• Bachelor (4-year college) degree in Chemistry or Biology and relevant experience in a GMP microbiology lab (including undergraduate research experience).
• Minimum of 5 years of relevant experience.

• Experience performing Bioburden, Endotoxin (chromogenic, turbidimetric methods), Sterility, Growth Promotion, Biological Indicator testing, Container Closure Integrity, and Identification Techniques.
• Ability to organize, manage and prioritize multiple tasks.
• Experience with Root Cause Analysis.
• Demonstrated ability to work both independently and as a part of a Team.
• Demonstrated problem solving and analytical thinking skills.

Additional Preferences:

• Experience with a LIMS (Laboratory Information Management System) system and MODA.
• Understanding of statistical tools and analysis.
• Excellent interpersonal skills and networking skills.
• Experience in a GMP QC lab environment.
• Demonstrated written and verbal communications skills.
• Strong attention to detail.
• Experience with lean lab and 5S concept.

Additional Information

• 8-hour days – Monday through Friday with flexibility to support weekends and/or overtime as needed.
• Applicant will work in various areas within the site.  Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
• Tasks may require repetitive motion (e.g., keyboarding).
• Minimal travel required.

Lilly is dedicated to helping individuals with disabilities to actively engage in the wo