Job Information
Lilly Biologist in Indianapolis, Indiana
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:
POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. Recently acquired by Eli Lilly and Company, POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT is a wholly owned subsidiary of Eli Lilly and Company.
The Microbiologist II role supports the development and implementation of the site’s sterility assurance program and environmental monitoring program. This role requires a meticulous approach and attention to detail to maintain our high standards of quality and compliance with regulatory requirements. This role will support the execution of team transformation map as well as internal and external audits/inspections.
Responsibilities:
Achieving the company’s strategic goals through the execution of day-to-day activities in support of product manufacturing and new product transfers in a timely manner.
Provide support for activities related to sterility assurance programs including air flow visualization, environmental monitoring performance qualifications, aseptic process simulations, cleaning, sanitization, and disinfection, gowning within the GMP classified areas, aseptic processing techniques, and contamination control.
Assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established.
Apply sterility assurance risk management to evaluate manufacturing processes and associated controls with respect to potential introduction of microbial, endotoxin, and particulate contamination.
Microbiological sampling and testing of raw materials, water, compressed air/ gas, routine and in process environmental monitoring, and finished product.
Read and review microbiology results.
Trending environmental monitoring data, bioburden, and sterility testing.
Preparing trend data reports in the required time, identifying adverse trends, and proposing CAPAs.
Ensuring compliance with aseptic operator qualification, process qualification and facility qualification through the media fill program.
Support of cleanroom qualifications, laboratory equipment qualifications, test method validations, and personnel qualifications.
Lead or perform root cause investigations associated with sterility assurance programs and environmental monitoring.
Provide training/ coaching for aseptic technique of microbiology and manufacturing personnel.
Provide support for activities related to sterility assurance programs including but not limited to:
Airflow Flow Visualizations
Environmental Monitoring Performance Qualifications
Aseptic Process Simulations
Cleaning, Sanitization, and Disinfection
Gowning within the GMP Classified Areas
Aseptic Processing Techniques
Contamination Control
Assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established.
Apply sterility assurance risk management to evaluate manufacturing processes and associated controls with respect to potential introduction of microbial, endotoxin, and particulate contamination.
Microbiological testing for raw materials, utilities (water, compressed air/ gas), microbiological media and finished products.
Conduct sampling for the evaluation of water, compressed air/ gas, and environmental monitoring.
Support aseptic operator qualifications, process qualifications and facility qualifications through the media fill program.
Prepare and analyze Biological Indicators in support of Validation and Qualification activities.
Read and review microbiological sample results pertaining to environmental monitoring, bioburden, sterility, growth promotion, media fills, and biological indicators.
Support sterility assurance/ microbiology qualifications for raw materials, finished products, and environmental monitoring of cleanrooms/ equipment.
Lead or perform root cause investigations associated with sterility assurance programs and environmental monitoring.
Participate in/ or provide technical support during internal and external audits.
Create, execute, review, and/ or approve technical documents related to sterility assurance programs and environmental monitoring.
Work within cross-functional teams to achieve the company’s strategic goals through the execution of day-to-day activities in support of product manufacturing and new product transfers in a timely manner.
Create and revise microbiology departmental documents.
Log and submit microbiology samples for microbial identifications.
General laboratory housekeeping duties and maintenance of department, premises, and equipment.
Basic Requirements:
BS in Microbiology, Biology, or a related field is required.
Demonstrated understanding and relevant experience of scientific principles required for manufacturing of parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance associated cGMP pharmaceutical manufacturing.
Strong analytical and problem-solving skills
Strong interpersonal and teamwork skills
Strong oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization.
Facility start-up and/ or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations.
Experience with data trending and analysis
Ability to analyze complex data and solve problems.
Additional Preferences :
Three to five (3-5) years of relevant experience in GMP preferred.
Excellent oral and written communication skills.
Demonstrated ability to function well in a collaborative team environment.
Ability to plan, develop and execute multiple projects under tight timelines.
Operate and execute with an extreme sense of urgency.
Excellent organizational and interpersonal skills
Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel)
Additional Information:
The physical demands of this job are consistent with a manufacturing environment. The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is in a Manufacturing site. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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 ( LillyRecruitingCompliance@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.
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