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 person to lead a fermentation/upstream development group, which will be expanding in scope and numbers over time. This group will be responsible for designing fermentation processes for extract production and cell free protein synthesis processes for proteins. These processes will be used for production of preclinical drug substance for in vivo studies. These processes will be subsequently transferred to a manufacturing site for GMP production of clinical material.
- Design fermentation/upstream and cell free protein synthesis processes that are efficient, robust and economical. Resulting materials must be acceptable for preclinical animal and human clinical studies.
- Design continuous extract production process at laboratory scale and transfer process to appropriate manufacturing scale.
- Coordinate work between fermentation/upstream development group and other groups within Sutro to meet project objectives and time lines.
- Present information and data in both written and verbal form.
- Work with Sutro manufacturing group and Contract Manufacturing groups for the technology transfer and production of therapeutic proteins.
- Manage activities of internal Sutro employees and Contract Manufacturing Organizations for validation of fermentation and upstream processes.
- Prepare dossiers and data packages for to assist with the interactions with Regulatory agencies.
- Interact with agents from Regulatory agencies during Pre-IND and IND meetings and participate in Pre-Approval Inspections.
BioSpace.com - 19 months ago