|
|
Description
Perform a variety of enzyme manufacturing activities, including cell culture, fermentation, filtration, purification and testing. Operations are performed in a clean room and are conducted under GMP guidelines.
Primary Duties / Responsibilities:
Preparation of media and buffers.
Cleaning, assembly, disassembly, and operation of bio-processing and laboratory equipment.
Fermentor/bioreactor
Cell expansion, fermentation, and harvest/primary recovery.- Complete assigned tasks which include sterilizing vessels, and bioreactor system
Accurately record process documentation
Troubleshoot equipment or process issues as required
Assisting in technical, operational, and documentation problems
Supporting in the execution of validation protocols (IQ/OQ/PQ) for operations equipment and control systems
Develop, review and/or revise processing records and SOPs to support manufacturing operations
Compliance to safety requirements, current Good Manufacturing Practices, Standard Operating Procedures and manufacturing documentation
Other duties as assigned
Experience providing technical support for a GMP manufacturing process, specifically in protein purification and fermentation.
Experience writing technical documentation: such as change controls, protocols, operating procedures.
Experience with commissioning, qualification, and validation of biopharmaceutical equipment and processes.
Demonstrated expertise in bioprocessing unit operations such as fermentation, chromatography, tangential flow filtration
Qualifications:
The ideal candidate must have a Bachelors and/or Masters in biological or other
science related field and 3+
years relevant industrial experience in the manufacture or development of FDA
regulated Biological
Products. Clinical or commercial manufacturing experience preferred. Broad
based technical knowledge with
manufacturing equipment (i.e. Bioreactors, filtration, mixers, purification etc.).
Must possess mechanical
aptitude. Only candidate with relevant industry experience will be considered for the position.
| | Source: VentureLoop |
|
| Other Jobs At Pacific Biosciences |
|
