Website Goodwin Biotechnology
Scope of Function: Execute 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.
Execute Manufacturing Batch Records (MBR) for specific projects to manufacture cell-derived biopharmaceuticals in compliance with cGMP guidelines and regulations. Activities include maintaining cell culture in various cell culture vessels; preparation of inoculum for bioreactor production and operation of various bioreactors.
Department responsibilities also include assistance with some cell culture process development activities consisting of: cell line characterization, media formulation evaluation, and inoculum process.
Reports to: Manager, DSP Manufacturing
- Maintain laboratory inventory and equipment
- Record process development activities and results in appropriate notebooks and spreadsheets
- Assist in writing standard operating procedures (SOPs), specifications, and manufacturing batch records (MBRs)
- Participate in cell culture operations according to MBRs in compliance with cGMP regulations and guidelines
- Participate in the thawing and freezing of cell banks.
- Maintain accurate and current documentation per GBI SOPs
- Assist with the creation and revision of procedures and material specifications
- Prepare medium and buffers to support USP projects
- Maintain the GMP manufacturing areas per GBI SOPs
- Assist with the execution of bioreactor operations including assembly, sterilization, setup, inoculation, daily checks, maintenance, harvesting, system shutdown and cleaning
- Possess a thorough knowledge of all company SOPs relating to cell culture and bioreactor operations
- Recording of counts and equipment used
- Adhere to all GBI policies and safety guidelines
- 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 Upstream Manufacturing.
- Associate Degree in Science or Engineering or related field and minimum of 3 years of work experience in a GMP environment, preferably in Upstream Manufacturing.
- Minimum of High School Diploma or equivalent and 5 years of work experience in a GMP environment, preferably in Upstream Manufacturing.
- QA, QC, FAC, MM, USP, PD-DSP, and Senior Management.