Downstream Manufacturing Specialist

3 days ago


Fort Lauderdale, Florida, United States Goodwin Biotechnology Inc Full time

Job Title: Downstream Manufacturing Specialist

About Goodwin Biotechnology Inc:

We are a pioneering biotech company focused on developing innovative solutions for biopharmaceutical production.

Salary: $70,000 - $90,000 per year

Job Description:

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.

Key Responsibilities:

  • Operates various pieces of pharmaceutical manufacturing equipment, including incubators, single-use mixers, depth filtration skids, TFF skids, chromatography skids, and in-process testing equipment.
  • Execute all Downstream Clinical Manufacturing and Development operations, encompassing but not limited to work functions in buffer preparation, chromatography execution, pre-viral and viral clearance, and technology transfer to manufacturing.
  • Develops ability to troubleshoot and maintain purification and tangential flow filtration systems.
  • Ensures adherence to Goodwin Biotechnology policies, GMP standards, and safety procedures.
  • Conducts and monitors critical processes, executes manufacturing batch records (MBR) for specific projects to manufacture cell-derived biopharmaceuticals in accordance with cGMP guidelines and regulations.
  • Communicates project progress, transfers data, process details, etc., to supervisor/manager.
  • Supports creation of batch records, SOP's, and protocols as needed.
  • Supports other manufacturing processes teams and other GBI groups as necessary to achieve manufacturing objectives.

Requirements:

  • Bachelor's degree in Science or Engineering.
  • Associate degree in science or engineering, or related field, and minimum of three years of experience with biologic production processes under GMP compliance. Downstream experience preferred.
  • Outstanding documentation skills, including comprehension and review & establishing batch production records.


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