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 35,000 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.

Organization Overview:

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. #WeAreLilly

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 receive safe and efficacious drug and drug/device combination products through effective execution of product testing.

Position Description:

The Sr. Principal Microbiologist participates and influences the design and installation of systems, procedures, and methods for the startup of the QC Microbiological testing and environmental monitoring labs at the site. The Sr. Principal Microbiologist leads the design and execution of method development, validations, technology transfers, and equipment evaluation/qualification. The Sr. Principal Microbiologist may perform non-routine lab work in support of those projects. The Sr. Principal Microbiologist utilizes their technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and completes thorough investigations of aberrant data and results. Outcomes of these activities including results, conclusions, and action plans are thoroughly and accurately documented by the Sr. Principal Microbiologist and may be published in regulatory and/or technical documents. The position is responsible for technical mentoring of lab staff, sharing technical information and best practice within the work group and across plant sites.

Responsibilities:

• Technical review, interpretation, and release of data.
• Contributes to annual product reviews and process validations as required.
• Perform technical training and mentor analysts through formal process/program.
• Review and approve change controls and deviations.
• Review and interpret data and document results of analyses and conclusions accurately and thoroughly in summary reports in accordance with GMP and local guidelines. Writes and publishes regulatory and/or technical reports and memos.
• Utilizes technical skills to lead or perform in-depth investigations into out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence.
• Develop investigational testing protocols and perform testing as required.
• Method verification/transfer/validation/remediation.
• Monitor method and process performance.
• Research and recommend new technologies.
• Improve lab quality systems; develop content, review, and approve SOPs and training as necessary.
• Contribute to development and implementation of Global Lab Quality Standards.
• Participate in network meetings and compendial forums.
• Comply with and implement safety standards.
• Provide technical oversight for Periodic Management Reviews.
• Interacts effectively with auditors and business partners to communicate and resolve issues and gain a clear and accurate understanding of each other’s requirements.
• Types of communication include:
  • Notification to management of quality issues.
  • Interaction with other functions and auditors.
  • Participation in internal/external audits.

Basic Requirements:

• Education
  • Bachelors (4-year) degree in a science field related to microbiology or biology.
• Experience
  • 7-10 years of demonstrated relevant experience in a GMP Microbiology Laboratory, preferably associated with GMP manufacturing.
  • Demonstrated proficiency in laboratory analysis including, but not limited to endotoxin, bioburden, sterility, non-viable and viable particulates, and colony identification.

Additional Preferences:

• Demonstrated strong problem-solving skills. Preferred training and demonstrated proficiency in Root Cause Analysis methodology.
• Demonstrated strong problem-solving skills. Preferred training and demonstrated proficiency in Root Cause Analysis methodology.
• Demonstrated strong interpersonal interaction skills.
• Ability to focus on continuous improvement.
• Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
• Deep understanding of compliance requirements and regulatory expectations.
• Strong oral and written communication skills and demonstrated through documentation and presentation skills.

Additional Information:

• Tasks may require repetitive motion and standing for long periods of time.
• 8-hour days – Monday through Friday.
• Occasional shift work when required within the lab.
• Required to be available off shift and respond to operational issues.
• Minimal travel required.

The job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification.

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.

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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

#WeAreLilly