Associate Director Sterility Assurance

Req ID #:  219730

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 Senior Manager Sterility Assurance, 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. 




•    Take ownership of the site's Contamination Control Strategy
•    Work closely with the operations group to develop a training program for aseptic processing
•    Lead Sterility Assurance team by hiring, training, motivating, and coaching employees 
•    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
•    Plan and coordinate 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
•    Provide technical guidance on any contamination related to non-conformances or events
•    Ensure that the site is operating under governing regulations for sterility assurance
•    Collaborate with cross-functional teams for the transfer of microbiological test methods to the site
•    Develop and sustain site practices for contamination control utilizing training and a purposeful presence on the operations floor
•    Influence operations area owners to ensure that quality issues are identified and appropriate corrective actions are implemented to maintain compliance
•    Comply with the EHS&S policy and procedures and demonstrate EHS&S best practices in all work activities
•    Adhere to and follows all procedures, policies, and guidelines ensuring compliance with cGMP and HPRA/FDA regulations 
•    Lives the Charles River core values of Care, Lead, Own, and Collaborate
•    Perform other duties as assigned.


Job Qualifications


•    Bachelor’s degree required, preferably in Microbiology or related science. 
•    At least 8 years’ experience in the pharmaceutical/Biotechnology industries conducting QC Microbiology testing, release testing and coordinating the activities of a QC Microbiology laboratory 
•    Minimum of 4 years’ previous leadership/management experience
•    Strong knowledge of cGMP compliance and cGMP manufacturing with preference for experience in a CDMO
•    Leadership experience in a cGMP environment, preferred
•    Knowledge of ICH, Eur. Ph., USP and FDA and JP guidelines 
•    SME level knowledge of Microbiology and aseptic manufacturing 
•    Experienced in supporting/writing OOS/OOE/OOT and/or deviation investigations 
•    Experience in supporting internal and/or external laboratory audits 
•    Advanced experience in the use of computer-based systems and applications associated with QC Microbiology testing analysis and reporting 
•    Ability and desire to take initiative on department-wide improvement projects and drive to completion.
•    Experience performing and managing performance of Environmental Monitoring of GMP cleanrooms.
•    Ability to process large amounts of paperwork in a timely and efficient manner.
•    Ability to work in a team-oriented, multidisciplinary, and multicultural environment

The pay range for this position is $138,800 - $161,800. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

About Cognate BioServices
Cognate BioServices, Inc., a Charles River Company, is the premier commercial-ready CDMO for cell and gene therapy needs. We are a dynamic, results-driven organization focused on providing the broadest range of expertise across the various cell types and technologies used in the commercialization of cell & gene therapies for regenerative medicine, cellular immunotherapy, and advanced cell therapy companies, organizations, and institutions.

We offer a unique combination of standard and custom services to companies across all points of clinical and commercial development. Our development and manufacturing services are focused on clients seeking rapid development of products from clinical studies into commercial manufacturing, with a unique capacity to handle all aspects of scale-up and commercial readiness.

Cognate leverages the combined know-how and expertise of its business, scientific, and technical teams to successfully develop and manufacture autologous and allogenic products across multiple cell-based technology platforms from start to finish, for you and your patients.

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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, 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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Nearest Major Market: Memphis

Job Segment: Pharmaceutical, Laboratory, Microbiology, Biology, Biotech, Science