Microbiologist- QC

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.

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

This role is at the CORE Indianapolis facility, formerly Point Biopharma.  The Center of Radioligand Excellence (CORE) is responsible for the Commercial launch of RLTs, supply of late-stage investigational products, and scale-up/optimization for Ph3 and commercial launches.

Position Description

This position relies on experience and knowledge in the field of Microbiology to perform work in a compliant manner. Supports the development and implementation of the site's sterility assurance and environmental monitoring programs. Maintains familiarity in a variety of microbiological concepts, practices, and procedures. Performs routine QC responsibilities as needed. Applies cGMP practices and ALCOA+ principles during execution of all work tasks. Presents innovative, creative, and compliant solutions to problems. Exhibits good problem solving and technical writing skills. Updates supervisor of progress on a regular basis. Role is based at Indianapolis Radioligand Therapy (RLT) manufacturing facility.

Overview

The major duties and requirements of the job are listed below and are not all-inclusive. May be expected to perform job-related duties other than those contained in this job description. Lilly employees embrace Operational Excellence in everything we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and our Quality System and Manufacturing Standards under the strict code of conduct guided by our Red Book assuring data integrity in all we do in order to deliver a reliable supply of medicine for people around the world.

Objectives

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

Accountabilities

 Performs the following routine QC Microbiology responsibilities as it relates to the specific area and is assigned by supervisor:

• Perform routine microbiological testing on in-process materials, final products, raw materials, environmental samples, finished goods.
• Performs material qualifications and QC inventory control.
• Performs identification of organisms.
• Performs Bioburden, Endotoxin, Sterility, Microbial Identification, and biological indicator testing.
• Prepares and maintains microbial stock culture.
• Performs method suitability (bacteriostasis/fungi stasis) testing.
• Assists in special projects (i.e. validations, microbiological studies, etc.).
• 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.
• 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.
• Creates, revises, or reviews documents such as SOPs, material specifications, protocols, and trend reports (water, environmental monitoring, or invalid assays).
• Performs analytical and deviations investigations.
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