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.
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:
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:
Additional Preferences:
Knowledge of aseptic manufacturing operations.
Strong investigational skills, working knowledge of microbiology assay development and validation.
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:
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$70,500 - $157,300
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.