Website Goodwin Biotechnology

Scope of Function: With general supervision the individual will perform routine and critical manufacturing operations, including but not limited to work functions in, Purification, Solution & Equipment Prep areas. Operate production equipment according to SOPs for the production of clinical and/or commercial products.

Reports to:  Manager, DSP Manufacturing

 

Specific Duties:

  • Assemble, prepare, and maintain process equipment; chromatography skids, columns, TFF systems, Viral Filtration systems and ancillary equipment. Troubleshoot and resolve process related issues.  Execution of critical and routine production operations
  • Buffer preparation and filtration
  • Operate general production equipment such as, Autoclaves, Scales, pH/Conductivity meters, etc.
  • Operate general manufacturing equipment in strict accordance with Standard Operating Procedures (SOPs) to complete tasks as noted above
  • Participate in writing and revising Standard Operating Procedures (SOPs) and batch production records
  • Demonstrate understanding in scientific concepts, technical operations, safety, and Good Manufacturing Practice (GMP)
  • Perform daily cleaning and sanitization of the GMP work area
  • Accurately follow SOPs for operating production equipment and performing process step
  • Follow specific techniques and operations while demonstrating an understanding of cGMPs (Current Good Manufacturing Practices) and how they apply to specific responsibilities
  • Assume ownership of production areas and associated equipment
  • Complete and review GMP documentation and production records for accuracy and make corrections in a timely manner
  • Adhere to Quality Standards and learn and comply with regulatory requirements
  • Perform Batch Record, Logbook, and Form Prep requests
  • Perform all other duties as assigned

Education and Experience:

  • BS degree in Science or Engineering, or other related field and 0 – 2 years of experience in a GMP work environment, preferably in Downstream Manufacturing
  • Associate Degree in Science or Engineering, or related field and minimum of 3 years of work experience in a GMP environment, preferably in Downstream Manufacturing
  • Minimum of High School Diploma or equivalent and 5 years of work experience in a GMP environment, preferably in Downstream Manufacturing

Interacts with:  

  • QA, QC, FAC, MM, USP, PD-DSP, and Senior Management.