Senior/Principal Microbiologist - Product Testing

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.

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

Organization Overview:

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply. 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 Product Testing Microbiologist participates in the startup of the QC Microbiological testing for products manufactured at the site. The Product Testing Microbiologist leads the design and execution of product microbiological test method verifications, validations, transfers, and equipment evaluation/qualification. This scientist may perform routine lab work in support of those projects. The Product Testing Microbiologist utilizes their technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and completes thorough investigations associated with out of specification or out of trend Product Testing results. Outcomes of these activities including results, conclusions, and action plans are thoroughly and accurately documented by Role Name and may be published in regulatory and/or technical documents. The position is responsible for technical mentoring of microbiologist and Product Testing analysts, sharing technical information and best practice within the work group and across plant sites.

Key Objectives/Deliverables:

• Technical review, interpretation, and release of microbiological Product Testing data, such as for Bioburden, Endotoxin, Sterility, and Mycoplasma.
• Contributes to process validations, such as Container Closure, Biological Indicator as required.
• Perform technical training and mentor analysts through formal process/program.

• Review and approve change controls and deviations.
• Review and interpret data, document results of analyses, and formalizing thorough accurate conclusions 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 spec 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.
• Comply with and implement safety standards.
• Provide technical oversight for Periodic Management Reviews.
• Interacts effectively with 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.

Minimum Requirements:

• Education
  • Bachelors (4-year) degree in a science field related to microbiology or biology.
• Experience
  • 4+ years of demonstrated relevant experience in a GMP Microbiology/Environmental Monitoring Laboratory, associated with Product Testing.
  • Demonstrated proficiency in microbiological laboratory techniques including, but not limited to Bioburden, Endotoxin, Sterility, and Mycoplasma testing.
  • Demonstrated experience of usage of sterility isolators, bioburden manifolds, Mycoplasma identification techniques.
  • Strong oral and written communication skills and demonstrated through documentation and presentation skills.

Additional Preferences:

• Experience with Rapid Sterility and Rapid Bioburden testing techniques.
• 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.

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.

#WeAreLilly