The Manufacturing Associate I Downstream is responsible for supporting the overall GMP downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing.
The Manufacturing Associate I Downstream role is critical to our process. Manufacturing life-saving medicines right the first time for themselves and their team with patient safety in mind is our priority. Quality, safety and on-time delivery is a must to be successful in this role!
• Performs Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record.
• Documents/Records cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Key documentation includes batch records and equipment logbooks.
• Performs the weighing, dispensing of raw materials for media and buffers
• Performs the preparation of small and large volume media and buffer solutions, filtration and transfer of product.
• Operates bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders, filter integrity testers etc.
• Dispensing, labeling, transfer/staging of raw materials and parts
• Actively participates in training activities, managing their individual training plan. Proficient and knowledgeable in the operation and basic troubleshooting of at least one manufacturing area. The Candidate
• High School Diploma with a minimum of 2-4 years GMP Manufacturing experience, OR
• Associate’s Degree in a scientific, engineering or biotechnology discipline with a minimum of 0-2 years related experience; coursework with biotechnology focus highly desirable, OR
• Bachelor’s Degree (BS/BA) from an accredited college or university with an emphasis in a scientific or engineering discipline and a minimum of 0-1 years relevant experience Position Benefits