This is a stellar opportunity within a thriving, growing and promising New England Biotech
company! You will be responsible for providing protein purification and cell culture process
engineering expertise for the successful manufacturing of monoclonal antibody and recombinant
protein therapeutic products. Your hands on responsibilities will also include:
* Designing and developing purification equipment used for column chromatography,
ultrafiltration, diafiltration, microfiltration and tangential flow filtration ? UF, DF,MF,
* Designing and developing cell culture equipment used for mammalian cell culture upstream
processing including bioreactors, fermentors, and cell banking equipment.
* Working with process control equipment and systems including Rockwell Automation, Allen
Bradley, Wonderware, Delta V, SCADA, PLC and DCS systems.
* Providing Manufacturing Support including monitoring trending processes, SPC, monitoring OOS
process results, and implementing corrective actions.
* Performing factory acceptance tests ? FAT, commissioning, equipment validation and facility
* Performing IQ/OQ/PQ validation activities.
* Providing outstanding equipment troubleshooting activities.
* Assisting in technology transfer activities.
* cGMP and GMP documentation activities writing SOPs and providing documentation within cGMP