Location:
Multiple LocationsClosing:
September 30, 2024The BioManufacturing Technician is responsible for performing various manufacturing activities related to the start-up and GMP production of a number of novel cellular products including compliance with regulatory agencies and associated guidelines.
Essential Duties:
- Obtain and maintain qualifications necessary for the performance of aseptic activities.
- Responsible for the production, formulation, and banking of cellular products (including GMP, GDP, and aseptic processing).
- Write, under supervision, GMP-required documents including standard operating procedures, product specifications, equipment specifications, and batch production records.
- Provide support in validation efforts related to the manufacturing process.
- Participate in all aspects of manufacturing activities including raw material support, cell culture, and continuous improvement.
- Consistently practice appropriate clean room behaviors and upkeep of clean room areas.
- Perform other duties as assigned.
Job Qualifications
• AS or BS in a scientific field is strongly preferred.
• Zero to 1 year of applicable experience in biotech or cell therapy.
• Must be able to work in a clean room environment that potentially includes hazardous materials and medical equipment (including blood, tissues, and needles).
• Must have the ability to perform algebraic math.
• 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.
• All other duties, as assigned.
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 biological 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 and over 200 licensed 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, and 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.
