Sutro Biopharma, Inc. is looking for an engineer to join the upstream process development team. You will be working to develop new processes to maximize our technology and seamlessly transfer processes and molecules to both internal and external Manufacturing sites.
- Develop, optimize and scale up coli fermentation and/or XpressCF+™ processes over a large range of scales (0.25L to 200 L) using a variety of techniques (fed-batch and continuous).
- Author technology transfer documents and support other regulatory submissions (DMF, IND, etc.).
- Represent process development to execute technical transfers to manufacturing facility and between manufacturing sites in the area of process support and provide guidance on process optimization.
- Analyze data with a variety of tools and techniques, including JMP or other statistical software packages.
- Interact with other departments such as Facilities, Manufacturing, Tech Transfer and Quality to facilitate process transfer and assist with any troubleshooting activities.
- 10% of domestic and international travel is expected.
- B.S. or M.S. in biochemical engineering, life sciences, or a related discipline with at least 10 years (B.S.) or 5 years (M.S.) of process development and tech transfer experience in the biopharmaceutical industry.
- Strong understanding of microbial recombinant protein expression processes (fermentation, centrifugation, cell disruption). Significant experience with fed-batch fermentation expected. Experience with continuous fermentations helpful.
- Significant hands-on experience with stainless steel fermentors, CIP, SIP, medium sterilization method is preferred. Familiarity with process control loops and associated instrumentation is a plus.
- Knowledge of statistical design of experiments, advanced data analysis, process validation, and Quality by Design concepts is expected.
- Extensive experience in fermentation scale-up to pilot and commercial scale under cGMP environment.
- Proven track record of excellent communication, both verbal and written, and the ability to build and maintain relationships with partners, customers, and collaborators.
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, and stock options.