Manager Biomanufacturing
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 Biomanufacturing Manager is responsible for leading all manufacturing activities related to the start-up and GMP production of novel cellular products for new and existing clients in compliance with regulatory agencies and associated guidelines. The Manager will also schedule appropriate resources to meet production schedules and maintain a state of safety, compliance, and control within manufacturing.
- Oversee all activities related to the start-up and production of new and existing client processes in accordance with quality and production timelines and agreements.
- Schedule and manage manufacturing staff ensuring adherence to production schedules; coordinate with relevant functions to ensure schedule adherence.
- Ensure a safe and compliant working environment by enforcing safety and quality policies and practices.
- Serve as manufacturing representative on cross-functional teams ensuring on-time completion of deliverables related to technology transfer, operations, production, and disposition.
- Advise and inform site and company leadership of issues with the potential to impact production timelines or Critical Quality Attributes of client products.
- Participate in Regulatory, Quality, and Customer inspections and audits as manufacturing systems and production process SME.
- Work closely with clients and internal functions to troubleshoot and solve issues related to client processes and production.
- Build, train, and develop highly skilled production teams capable of producing cell therapy products in accordance with regulatory guidelines and Cognate quality standards.
- Oversee the drafting, review, and approval of process specific and Internal Quality System documents.
- Foster a culture of continuous improvement; identify opportunities and lead implementation of improvement activities, as required.
Job Qualifications
- BS or MS in a scientific field.
- Minimum of 4 years of applicable experience.
- Minimum of 2 years demonstrated success in a supervisory role.
- Exhibits Exceptional leadership skills and deep knowledge of GMP
- Must be detail oriented and have excellent organizational skills.
- Must display a high degree of professionalism and confidentiality.
- Must demonstrate initiative to remain apprised of relevant industry and regulatory trends.
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.
For more information, please visit www.criver.com.
Nearest Major Market: Memphis
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