Scientist/Engineer - Process Microbiology

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:

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

Position Brand Description:

This position is responsible for process microbiological support for biotechnology manufacturing processes, overseeing a robust Product Protection Control Strategy against Adventitious Agents in a cGMP environment, and building the organization’s knowledge of aseptic manufacturing operations.  This role partners with Operations, QC Microbiology, Engineering, other TS/MS Scientists, and Quality on risk-based assessments, testing strategies and troubleshooting.  

Key Objectives/Deliverables:

Manage for Results /Strategic Planning:

Floor Support

Monitors (trends) in-process microbiological data and presents analyses in Manufacturing Process Team meetings.  Provide on-the-floor microbiological support for manufacturing processes including generation and maintenance of manufacturing support documentation (e.g. SOPs, trend analyses, evaluation protocols) Assist/Lead deviation investigations.  Troubleshoot suspected microbiological contamination incidents. Collaborate with Operations and Engineering to implement equipment, procedure and/or automation improvements to mitigate identified microbiological risk points. Provide microbiology guidance on facility and process-related controls and changes.

Product Protection Control Strategy Oversight

Oversee process contamination prevention and control according to Product Protection Control Strategy. Develop in-process microbiological acceptance criteria, sampling requirements, summations, procedures and reports.  Collaborate with QC Microbiology on specifications and microbiological control strategy. Serve as subject matter expert for evaluation and mitigation of microbiological trends.

Technology Transfer & Cross-Functional Support:

Support microbiological requirements for in-process hold time studies as well as small-scale studies to support hold time, resin cleaning, and other process validation activities. Collaborate with Validation Technical Services on microbiological requirements for cleaning/SIP validation and facility/equipment qualification. Collaborate with Quality Control in the development and execution of the facility-based environmental monitoring and clean utilities microbiology programs for the site.

Basic Requirements:

• B.S. in Microbiology or related science with a minimum of 0-7 years experience in a cGMP biopharmaceutical manufacturing environment. Would also consider candidates with a BS in Chemical Engineering with experience in contamination controls and/or microbiological controls.

Additional Preferences:

• Knowledge of aseptic manufacturing operations.
• Strong investigational skill.
• Demonstrated strong data-driven decision-making and problem-solving capabilities.
• Demonstrated strong interpersonal skills in cross-functional teamwork environment.
• Demonstrated strong communication skills, both oral and written. 
• Technical writing including position papers, validation reports, and microbiological investigations.
• Demonstrated ability to participate in and facilitate decision-making.

Additional Information:

• Travel required.
• Lifting not required.
• Not required to be on call.
• Shift work may apply.

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). 

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