Biochemical Process Engineer/Sr. Biochemical Process Engineer
Sutro Biopharma, Inc. - South San Francisco, CA

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Sutro Biopharma, located in South San Francisco, is developing a new generation of antibody drug conjugate therapeutics and bifunctional antibody-based therapeutics for targeted cancer therapies. These therapeutics will significantly extend the clinical impact of current oncology therapeutic approaches and are beyond what can be envisioned with current cell-based expression technologies. Sutro's biochemical synthesis technology, which underpins these therapeutics, allows the rapid and systematic exploration of many protein drug variants to identify drug candidates. Once these product candidates are identified, production can be rapidly and predictably scaled up to commercial levels. Sutro has established a Good Manufacturing Practice (cGMP) facility for the production of clinical supplies of materials using its biochemical protein synthesis platform. Sutro Biopharma is collaborating with pharmaceutical and biotech companies in the discovery and development of novel protein therapeutics.

Sutro Biopharma, Inc. is looking for energetic and talented individuals to join its multidisciplinary research and development team. You will be working to maximize our technology and internal and collaborative product development initiatives in a fast paced environment.

We are seeking a candidate to lead an effort in process engineering in the process development department. The candidate is responsible for the identification, acquisition, installation, qualification and operation of process equipment for various unit operations, which include fermentation, fermentation harvest equipment, recovery equipment including centrifugation, filtration, freezing pelletizers and lyophilization/drying equipment. This position is also responsible for integrating the equipment into upstream extract production processes and processes for drying E. coli extract and then optimizing the processes so that they are economical and efficient. You will work with manufacturing to ensure the equipment is appropriate for GMP manufacturing of biopharmaceuticals. You will also monitor process unit operations during development and manufacturing for consistency using statistical process control methods.

  • Identify equipment for new processes and for improvement of existing processes.
  • Responsible for the installation, qualification and operation of new equipment and will train others on the proper use of the equipment.
  • Work with IT, Facilities, Manufacturing and Quality to ensure that equipment is appropriate for GMP manufacturing and that it is properly installed, qualified and operated.
  • Increase efficiency and improve economics of various unit operations by understanding the inputs and outputs of the unit operations and balancing these for optimal productivity.
  • Analyze data with a variety of tools and techniques including JMP or other statistical software packages.
  • Author development reports regarding process design and process improvements.
  • Author regulatory documents and review regulatory data packages for interactions with regulatory agencies.
  • Represent process development during face-to-face interactions with regulatory agencies and defend process designs.
  • Author technology transfer packages and serve as a resource during technology transfer and process implementation to manufacturing.
  • Maintain database on equipment and developments in the area of process equipment improvements.
  • Interact with other departments such as facilities, manufacturing and Quality to ensure process control.
  • Assist Quality with manufacturing investigations and serve as a resource for these investigations. - 2 years ago - save job