Sutro Biopharma, Inc. is looking for energetic and talented individuals to join its multidisciplinary research and development team. You will be working to develop new processes to maximize our technology and enhance our internal and collaborative product development initiatives in a fast-paced environment.
Coordinates and performs routine and non-routine GMP microbiological testing, including environmental monitoring (EM) of classified clean rooms and critical utilities (RODI, Clean Steam, Clean Dry Air), release of product, and testing for validation protocols. Coordinates testing performed by contract laboratories as needed. Performs organism identification. Reads and interprets microbiological cultures and other related tests including, but not limited to, environmental monitoring, bioburden tests, growth promotion, microbial limits tests, endotoxin (LAL), and TOC testing. Writes and executes protocols to perform validation, technology transfer and troubleshooting for microbiology testing. Writes standard operating procedures (SOPs) for the QC Microbiology laboratory. Reviews environmental monitoring data and laboratory equipment documentation and records. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness. Prepares EM trend reports. Performs and receives training on microbiological methods. Interacts with Facilities, Manufacturing and QA as needed to coordinate testing and support investigations of EM and microbiological excursions. Works with contract laboratories and equipment vendors as needed. Must have experience in a GMP biopharmaceutical/ pharmaceutical manufacturing environment. May be required to become cross-trained on QC Analytical methods and testing.
- 4-year science degree (B.A. or B.S.) with at least 2 year in a cGMP laboratory
- Experience with aseptic technique skills
- Experience with microbiological testing such as Bioburden, PCR, LAL, Growth promotion, Microbial Identification, Freeze/thaw isolates, and environmental monitoring/testing (total particulates, viable air particulates, and surface monitoring) and utility systems monitoring/testing (bioburden, TOC, conductivity, dew point, oil content, and endotoxin).
- Ability to communicate clearly, in writing and verbally, with peers, upper management and with external customers
- Understanding of scientific theories, principles, and techniques used in biological and analytical test procedures
- Understanding of basic microbiological compendial requirements and pharmaceutical industry standards. Experience with application of compendial requirements is preferred
- Strong technical writing skills with experience writing protocols, reports, discrepancies and/or deviations
- Ability to exercise sound judgment, reasoning, problem solving and decision making
- Independently capable to design, execute, interpret and review results
- Ability to work off-shift, weekends and holidays, as needed
- Proficient in computer software such as Microsoft Office. Experience with additional software that can be applicable to improving current systems is preferred
- Experience and ability to work with bacterial and fungal cultures
- Ability to sit, stand and work within work space for extended periods of time
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.