Bioprocess Specialist, Downstream

GBI Bio; Fort Lauderdale (FL); On-site; USD 60,000 - 90,000; Full time

Job summary

GBI Bio is seeking a Bioprocess Specialist I to support downstream GMP operations from harvest through chromatography and viral filtration. You will document work following ALCOA+ principles and ensure safety and quality compliance in a cGMP environment.

Responsibilities include operating skids and equipment, performing buffer prep, chromatography, and data recording, while collaborating cross-functionally to resolve issues and transfer knowledge to manufacturing teams.

Qualifications

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

Responsibilities

• 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.

Skills

Attention to detail

Documentation skills

Collaboration

Education

BS degree in Science or Engineering

Associate degree in Science or Engineering

High School diploma or equivalent

Job description

Scope of Function

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

Description

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.

Requirements

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.