What are the responsibilities and job description for the Biomanufacturing Manager, Cell & Gene Therapy position at Charles River Laboratories?
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.
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
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 Cognate 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 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
Compensation Data
The pay range for this position is $94,000 - $120,000. Please note that salaries vary within the range based on factors but not limited to experience, skills, education and location.
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.
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.
Salary : $94,000 - $120,000
