Scope of Function:

The Bioprocess Specialist I position reports to the Downstream Manufacturing senior Manager. This role is responsible for supporting the overall Downstream GMP 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/III and commercial GMP manufacturing.

Specific Duties:

• Operates pharmaceutical manufacturing equipment such as: incubators, single use mixers, depth filtration skids, TFF skids, chromatography skids and in process testing equipment.

• Executes all Downstream Clinical Manufacturing and Development operations, including but not limited to work functions in buffer preparation, chromatography execution, pre-viral and viral clearance, and technology transfer to manufacturing.

• Learn to Trouble-shoot and maintain purification and tangential flow filtration systems.

• Adheres to Goodwin Biotechnology policies, GMP standards and safety procedures.

• Performs and monitors critical processes, execute manufacturing batch records (MBR) for specific projects to manufacture cell-derived biopharmaceuticals in compliance with cGMP guidelines and regulations.

• Informs supervisor/manager on progress of projects, transfer data, process details, etc.

• Supports the development of batch records, SOP’s and protocols as required.

• Supports other manufacturing processes teams and other GBI groups as necessary to achieve manufacturing goals.

Education and Experience Required:

• BS degree in Science or Engineering.

• Associate degree in science or engineering, or related field and minimum of 3 years of experience with biologic production processes under GMP compliance. Downstream experience preferred.

• Excellent documentation skills including comprehension and review & establishing batch production records.