Downstream Manufacturing Scientist

Position Summary

• 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 4 - 5years 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.