GMP, Manufacturing Associate II, Upstream CDMO
At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families.
The Upstream GMP Manufacturing Associate II will work directly with a range of bioreactor and recovery technologies such as single-use systems (adherent and suspension), filtration technologies (TFF and depth), and centrifugation following aseptic techniques and procedures in a cGMP environment.
Duties and Responsibilities
• Ensure safety of manufacturing area and work practices.
• Provide guidance, and direction to staff to create a quality-centric organization.
• Coordinate planned upstream manufacturing floor activities.
• Oversee and prepare upstream buffers/media aliquots in accordance with procedures.
• Assist Manufacturing Science & Technology in preparing Batch Production Records (BPRs).
• Ensure team members are qualified to execute GMP manufacturing.
• Ensure proper documentation and execution of Batch Production Records for assigned projects by actively participating in batch production.
• Participate in and/or lead incident investigations.
• Interact with other departments to implement approved process improvements.
• Monitor processes using automated production systems and controls with limited supervision.
• Engage in equipment preparation, sanitation, and disinfection.
• Perform other tasks as assigned to support GMP Manufacturing that ensure sustainable right-first-time performance.
• Other responsibilities as needed.
• High School Diploma or Associate Degree with 3-7 years of experience in Biopharmaceutical Upstream Manufacturing in a GMP environment; or
• Bachelor of Science in science or Engineering and 2-4 years of experience in Biopharmaceutical Upstream Manufacturing in a GMP environment.
• Experience with Upstream Operations in the Biopharmaceuticals Industry -single-use bioreactors, aseptic techniques, product recovery (centrifugation, depth filtration, etc.).
• Experience in the preparation of media and buffers at large scale (>20L).
• Preparation of material for autoclaving and operation of autoclave.
• Ability to operate manual and semi-automated in support of routine production with minimal supervision.
• Ability to work in a team and collaborative environment.
• Great attention to detail. time management, and project management.
• Previous work in viral or vaccine production highly desired.
• Previous experience working for a Contract Manufacturing Organization (CMO) preferred.
• Good communication skills.
• Basic computer skills-knowledge of Microsoft Word and Excel.
This position is located at our Rockville, MD site (Shady Grove area)