Sterility Assurance Lead

Req ID #:  218532

Memphis, TN, US, 38118 Memphis, TN, US, 38118

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

Job Summary


As our Sterility Assurance Lead, you will act as SME for sterility assurance joining a talented and diverse team playing a key role in ensuring that all products leaving Charles River Laboratories meet the standards required.


Job Duties and Responsibilities

  • Take ownership of the site's Contamination Control Strategy
  • Work closely with the operations group to develop a training program for aseptic processing
  • Provide training in aseptic behaviors and principles to the site
  • Partner with the QC Micro Lab to develop the clean utilities and environmental monitoring program for the site
  • Supervise team of Laboratory Technicians and Lab. Coordinators, scheduling their work, vacations, and holidays. Planning & coordinating analysis of products, raw material, in-process samples, final bulk and final product samples, and water samples
  • Establish, in conjunction with the operations function, the sites gowning strategy and cleaning and sanitization program
  • Monitor and review microbiological data to detect trends
  • Liaise with the global science and technology team to ensure best practices are in place concerning sterility assurance
  • Ensure that the site is operating under governing regulations for sterility assurance
  • Maintain and develop site practices for contamination control etc. utilizing training and a purposeful presence on the operations floor

Job Qualifications


  • Bachelor’s degree in science or engineering.
  • Third level qualification to degree level in a relevant technical discipline, ideally microbiology, science/engineering.
  • 3 years supervision experience in Laboratory areas
  • Minimum 5 years’ experience in the pharmaceutical industry or biopharma industry in a Quality/Operations role
  • Minimum 1 years’ experience in an aseptic sterile fill-finish manufacturing environment

The pay range for this position is $29.57 - $33.75.  Please note that salaries vary within the range based on factors but not limited to experience, skills, education and location.  



Compensation Data

About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs.  Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.


About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.


With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. 


At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.


Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.


If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.


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