QC Microbiologist

Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics.

Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need. To date, Sutro's platform has led to cytokine-based immuno-oncology therapies, ADCs, vaccines and bispecific antibodies directed at precedented targets in clinical indications where the current standard of care is suboptimal.

The platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.

In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells.

Sutro Biopharma, Inc. is seeking a driven and talented individual to join our research and development team as we change the future of oncology. While collaborating with cross-functional departments, you will play a key role in maximizing our technology and progressing our novel therapeutics. We are dedicated to making a difference in the lives of patients, both as individuals and as part of a team.

Responsibilities

• 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, and Nitrogen), 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.
• May be required to become cross-trained on QC Analytical methods and testing.

Qualifications

• 4-year science degree (B.A. or B.S.) with at least 1 year in a cGMP laboratory
• Experience with aseptic technique
• Experience with microbiological testing such as Bioburden, LAL, Growth promotion, Gram Stain, 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 workspace for extended periods of time.

Sound exciting? Apply today and join our team!

Please submit resume for Req. #2192 to jobs@sutrobio.com . Please visit our website at www.sutrobio.com for more information.

Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP (Employee Stock Purchase Plan) and stock options.

As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into