Scope of   Function: 

The Bioprocess   Specialist I position reports to the Downstream Manufacturing Supervisor.

Bioprocess Specialist I   shall perform the production process under cGMP ensuring adherence to safety   protocols and quality standards. This role is responsible for supporting the   overall Downstream GMP process through the application of broad knowledge of   theories and principles. They will perform operational and routine tasks in   the production of bulk biologics from harvest of cell culture systems through   column chromatography, tangential flow filtration and viral filtration to   bulk drug substance for Phase 1/2/3 and commercial cGMP manufacturing. They   will document all work performed following ALCOA+ principles.

Specific Duties:

• Operates pharmaceutical manufacturing equipment such as 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.

• Collaborate with colleagues and supervisors to troubleshoot and resolve issues in a timely manner.

• Demonstrates, understands, and adheres to Goodwin Biotechnology policies, GMP standards and safety procedures.

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

• Perform routine maintenance and cleaning of production equipment.

• Accurately document and record production data and activities according to ALCOA+.

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

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

• Supports Goodwin Biotechnology QA during audits and regulatory inspections.

• Participate in training and continuing education to stay current with industry developments and regulations.

• Adhere to safety protocols and maintain a clean and organized work environment.

• Follow Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs) to maintain compliance with   regulations

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

 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, with +2 years of industry experience with biologic production processes under CGMP compliance.

• High School diploma (or equivalent) with +5 years of experience with biologic production processes under GMP compliance. Downstream experience preferred.

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