Director, Microbiology and Sterility Assurance
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
The Director Microbiology and Sterility Assurance be responsible for all strategy, process, compliance, and execution of critical activities to assure sterile processes, controlled environments, and biocontamination controls are maintained for the site. This includes but is not limited to: sterility assurance, environmental monitoring of the faciity, quality control microbial testing, utility monitoring, and site contamination control strategy. This position reports to the Site Head of Quality for the Memphis site. This person will be responsible to partner with Global Quality stakeholders for development, implementation, and continuous improvement of microbial control and sterility assurance standards. The person filling this role will be responsible for the leadership, development and training of team members within their oversight as well as providing supportive leadership and strategic direction to operate with and maintain compliance to regulatory and industry quality standards in support of existing and new cellular therapy production.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Responsible for microbiological testing and monitoring functions to support the manufacturing and release of products within the Memphis Laboratories. Ensure that these activities are timely, efficient and productive while adhering to client’s requirements and operational and quality parameters.
• Will liaise with the Manufacturing, Quality Assurance, Supply Chain, Project Management, Facilities, and other GMP Quality Control units to ensure contamination control and sterility assurance standards are maintained across all site operations.
• Preparation of Revenue and Capex Budget as per spent analysis project. Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site.
• Maintain quality system controls for area of oversight to ensure no critical and major market complaints or audit findings.
• Ensure that all statutory and regulatory compliance standards are regularly monitored and in a state of compliance for area of oversight, as applicable.
• Responsibile to oversee all PQ requirements for Environment and Utilities systems as well as routine monitoring and trending of systems.
• Take appropriate steps to reduce waste and losses in the microbiology and contamination control processes and improve efficiency in ways of working.
• Ensure timely sampling, analysis, release and trending of environmental and utility system samples.
• Ensure completion and adherence to training of subordinates in area of oversight as per the job requirement.
• Provide leadership to and ensure necessary Quality oversight to areas within span of control.
• Effectively model, demonstrate and live an employee-focused leadership style that prioritizes compliance, respectful and professional cross departmental collaboration, accountability, and the well-being, personal, and career development of each employee.
• Effectively model, demonstrate and live the Charles River core values of Care, Lead, Own, and Collaborate
• Lead, coach and mentor individuals from all parts of the organization with varying levels of experience. Be a valued resource for the site in all matters related quality and compliance.
• Perform all other related duties as assigned.
Job Qualifications
• Minimum Bachelors degree in life sciences or related field. An advanced degree in the life sciences is preferred, but not essential, based on experience
• Minimum 10 years of experience in a biologics, pharmaceutical, medical device, or related industry.
• Minimum 5 years as a Leader with direct reports
• ISO Lead Auditor training, desirable.
• Certified Quality Engineer (ASQ), desirable
• Experience working in a GMP Biologics environment required.
• Experience preferred with a CDMO business and/or gene-modification modalities, cell-based gene therapies, and strong scientific background in QC testing required for such products.
• Complete competency with electronic document managements systems and other information management systems (QMS, ERP, LIMS,MES etc)
• Familiarity preferred with applicable regulatory requirements and compendia concerning cGMP manufacturing and testing of human cells (21CFR210, 211, 820 and 1271; Eudralex, USP, EP and ICH).
• Understanding of analytical method qualification and validation per USP, EP and ICH guidelines.
• Ability to maintain a high degree of accuracy and attention to detail.
• Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively.
• Outstanding verbal and written communication skills.
• Proficiency in Microsoft Office (Word, Excel, Outlook, etc.) is essential.
The pay range for this position is $176,500 - $207,680. Please note that salaries vary within the range based on factors but not limited to experience, skills, education and location.
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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment Opportunity
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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 crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit www.criver.com.
Nearest Major Market: Memphis
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