Upstream Manufacturing Associate |
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Scope of Function: Assists in all Upstream Development/Manufacturing activities including; cell culture, cell banking, media optimization, seed train design, feed strategy, bioreactor parameter optimization, harvest clarification, and technology transfer to manufacturing.
Responsible for the execution of a Manufacturing Batch Records (MBR) for specific projects to manufacture cell derived biopharmaceuticals in compliance with cGMP guidelines and regulations. Activities include cell culture in various cell culture vessels including preparation of inocula for bioreactor production, and operation of various bioreactors.
Department responsibilities also include cell culture process development activities, consisting of cell line characterization, media formulation evaluation, and inoculum process development.
Reports to: Upstream Manufacturing Manager
Specific Duties:
Education and Experience Required:
Education:
Interacts With:
Responsible for the execution of a Manufacturing Batch Records (MBR) for specific projects to manufacture cell derived biopharmaceuticals in compliance with cGMP guidelines and regulations. Activities include cell culture in various cell culture vessels including preparation of inocula for bioreactor production, and operation of various bioreactors.
Department responsibilities also include cell culture process development activities, consisting of cell line characterization, media formulation evaluation, and inoculum process development.
Reports to: Upstream Manufacturing Manager
Specific Duties:
- Maintains laboratory inventory and equipment
- Records process development activities and results in appropriate notebooks and spreadsheets
- Assists with writing SOPs, batch records, and experimental plans and reports
- Multi-task multiple projects as necessary
- Performs cell culture operations according to Manufacturing Batch record in compliance with GMP regulations and guidelines
- Thawing and freezing of cell lines
- Maintains accurate and current records per GBI specifications
- Creation and revision of procedures and material specifications
- Prepares medium and buffers as required
- Maintains the GMP Manufacturing area as per GBI specifications
- Performs bioreactor operations including assembly, sterilization, setup, Inoculation, daily checks and maintenance, harvesting, system shut down, and cleaning
- Possesses a thorough knowledge of all company SOPs relating to cell culture and bioreactor operations
- Performs environmental monitoring as required
- Performs all tasks assigned by the Upstream Manufacturing Project Leader
- Adheres to all GBI policies and safety guidelines
Education and Experience Required:
Education:
- BS in biological or physical science (degree requirement may be waived with relevant experience)
- 1 - 2 years of cell culture experience
- GMP manufacturing experience beneficial but not required
Interacts With:
- Downstream Manufacturing
- Process Development
- Materials Management
- Quality Control and Quality Assurance groups