Downstream Manufacturing Associate
3 days ago
Piscataway
Job Description: The Downstream Manufacturing Scientist is a hands-on position responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian based biosimilars. The candidate will be responsible in the purification of 50L to 1000L volumes engineering, clinical and commercial batches in a cGMP environment. This position requires technical expertise in AKTA purification skids or similar, TFF and knowledge of initiating batch records, protocols, investigations and other technical documents. Work in a team environment to execute batches and can work independently with minimum supervision. This position requires extensive technical expertise in mammalian cell-based purification processes, cGMP manufacturing and compliance for BLA requirements. Essential Duties & Responsibilities • Perform downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis. • Provides technical direction in the execution and development of the purification process., • Uses programs to collect and evaluate operating data to conduct on- line adjustments to products, instruments or equipment. • Ensure that engineering and clinical batches are executed in a timely manner., • Establishes operating equipment specifications and improves manufacturing techniques., • Works with other teams and outside vendors to resolve technical issues as well as maintenance of production equipment. • Should follow GMP instructions in the manufacturing area and take the lead to follow environmental health and safety policies. • Coordinate the conduction of investigations and corrections for issues found during the batch execution process. • Performs other functions as required or assigned, • Complies with all company policies and standards Position Requirements and Qualifications Education: • Requires a Bachelor or Master’ degree in chemical, biological or biochemical sciences and a minimum of 0-1 years of related experience in the biopharmaceutical industry., • Previous experience working in GMP and aseptic manufacturing environment., • Experience working with AKTA Process skids or similar and familiarity of single use manufacturing consumables such as bags, tube sets, columns and process manifolds. • Possess knowledge to execute engineering and clinical batches; familiar with GMP documentation