Associate Director Sterility Assurance

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. 

ESSENTIAL 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
•    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.