Manufacturing Manager

Manufacturing Manager Req ID #:  142971 Location: 

Memphis, TN, US, 38104 Memphis, TN, US, 38118 Memphis, TN, US, 38118 For 70 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.

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.    Job Summary  

We are seeking a Manufacturing Manager for our Cognate BioServices site located Memphis, TN.  

The following are responsibilities related to the Manufacturing Manager:

The Manufacturing 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.

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ESSENTIAL DUTIES AND RESPONSIBILITIES:

•Oversee all activities related to the start-up and production of new and existing client processes inaccordance with Cognate quality and production timelines and agreements.

•Schedule and manage manufacturing staff ensuring adherence to production schedules; coordinatewith relevant functions to ensure schedule adherence.

•Ensure a safe and compliant working environment by enforcing safety and quality policies andpractices.

•Serve as manufacturing representative on cross-functional teams ensuring on-time completion ofdeliverables related to technology transfer, operations, production, and disposition.

•Advise and inform site and company leadership of issues with the potential to impact productiontimelines or Critical Quality Attributes of client products.

•Participate in Regulatory, Quality, and Customer inspections and audits as manufacturing systems andproduction process SME.

•Work closely with clients and internal functions to troubleshoot and solve issues related to clientprocesses and production.

•Build, train, and develop highly skilled production teams capable of producing cell therapy products inaccordance 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 ofimprovement activities, as required. Job Qualifications  

The following are minimum qualifications related to the Manufacturing Manager position:

•BS or MS in a scientific field

•Minimum of 3 years or equivalent 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 possess effective written and oral communication skills

•Must display a high degree of professionalism and confidentiality

•Must demonstrate initiative to remain apprised of relevant industry and regulatory trends

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

Vaccine Mandate

Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021.  Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees. 

Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

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.

For more information, visit www.cognatebioservices.com 

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

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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