Scientist/Senior Scientist: Upstream Process Development
Located in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADC's). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor.
This individual will work in the upstream process development group. Responsibilities include CHO cell culture cell expansion, shake-flask process optimization, bioreactor production, and primary recovery operations. Detailed record keeping, data analysis, report generation, and participation and presentation at group meetings are included in job function. The position requires strong knowledge with biologics therapeutic production processes and analytical methods operations in the pharmaceutical industry.
- Implement upstream processes using bioreactors for production of in house generated biologics
- Lead the optimization for various parameters in upstream processes such as media and feed strategies, cell culture scale up and primary recovery processes
- Assure cGMP compliant cell line development and cell banks for production for research, toxicology and clinical materials to meet project timelines. Establish relevant cGMP documents to support successful implementation of process technology in clinical/commercial manufacturing operations
- Transfer cell lines, methodologies, processes and documentation to support drug substance manufacturing and follow-on support
- BS or above in engineering or biology related field and +10 years’ previous experience in cell culture process development in the biotechnology industry
- Solid experience with bioreactor control systems and analytical equipment for cell culture process analysis
- Strong knowledge and experience of GMP manufacturing processes and cGMP quality systems Experience with process and equipment validation systems a plus
- Knowledge and experience in the transfer of upstream process to manufacturing
- Experience with robotics, high-throughput processes and automated data management a plus
- Ability to work across disciplines from research to development to manufacturing
- Excellent aseptic handling and operations technique.
- Strong attention to detail and meticulous record keeping skills, ability to maintain careful and timely documentation of all activities
- Strong mechanical aptitude and ability to troubleshoot equipment and systems
- Ability to introduce new technologies to improve and accelerate upstream process development
- Technical writing skills to create and revise operating procedures and process documentation
- Schedule flexibility including weekend and occasional off-hours coverage.
- Up to 10% international travel is required.