Job Description

The Downstream Manufacturing Supervisor 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 and supervise 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.

• Prepare / review all quality management related documents (Deviation / Change control / investigation reports etc.)

• 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.