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.