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