Bioprocess Specialist, Upstream

Goodwin Biotechnology Inc • Plantation, FL

2d • Onsite

About The Position

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.

Requirements

• 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.
• Minimum of High School Diploma or equivalent and 3 years of experience with biologic production processes under GMP compliance.
• Excellent documentation skills including comprehension and review & establishing batch production records.

Nice To Haves

• Downstream experience preferred.
• Upstream experience preferred.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level