Bioprocess Specialist, Upstream

Scope of Function:

The Bioprocess Specialist position reports to the Upstream Manufacturing, Manager. Prior experience in GMP manufacturing, operation of GMP process equipment and aseptic technique are prerequisites. This role is responsible for supporting the overall Upstream 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 1/11/111 and commercial GMP manufacturing.

Specific Duties:

• Operates pharmaceutical manufacturing equipment such as: incubators, wave reactors, single-use and stainless-steel bioreactors, single use mixers, depth filtration skids, TFF skids, chromatography skids and in process testing equipment.

• Executes all Upstream Clinical Manufacturing and Development operations, including but not limited to work functions in cell culture, cell banking, media optimization, seed train preparation, bioreactor operations, harvest/clarification, and technology transfer to manufacturing.

• Demonstrates, understands, and 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 regulation.

• 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.

• 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.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.

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.

• Minimum of High School Diploma or equivalent and 3 years of experience with biologic production processes under GMP compliance. Upstream experience preferred.

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