QC Data Reviewer (San Carlos, CA)
Sutro Biopharma, Inc. is looking for a driven and talented individual to join the Quality Control team in San Carlos, Ca. as we change the future of oncology. The QC Data Reviewer will report to the Director of Quality Control and will be responsible for ensuring compliance with Sutro Quality systems, policies and procedures and in accordance with US and international regulatory agencies, ICH, general cGMP and international guidance. While collaborating with cross- functional departments, this will be a key role in maximizing our technology and progressing our novel therapeutics to the next phases.
- Data Review of Raw Material, Release and In-Process testing, Stability, Cleaning Verification samples, Microbiological testing, and Analytical test method Qualification/Verification/Transfer/Validation
- Review the data to comply with cGMPs, GDP, FDA, EMA and ICH Guidelines
- Continuously improve and educate analytical chemists to improve analytical data reporting, adhering to GDP and cGMP and to increase efficiency, compliance, and quality
- Review analytical data to ensure ALCOA+
- Ensure compliance of testing with laboratory procedures, test methods and protocols. Work with laboratory personnel to correct any errors and omissions in GMP documentation and promote a cGMP culture. Ability to pay attention to detail, focus and multitask on review of analytical laboratory data
- Review time of use logs on cGMP instrumentation and other analytical equipment. Review audit trails on computer systems used to acquire and process data from instrumentation (e.g., Chromeleon, Labx). Ability to use a computer to accurately to analyze data and generate reports as needed
- Strong technical knowledge of various analytical equipment, techniques, and methodology (e.g. liquid chromatography, pH, iCIEF, ELISA, SEC, CE-SDS, TAMC)
- Strong prioritization, organizational skills and detailed oriented. Coordinate and discuss with other team members for continuous improvement of the data review process. Discussions and provide suggestions to QC analysts for continuous improvement of the GDP within cGMP requirements and applicable written SOPs, test procedures and methods Completion of work within the assigned time frame, to perform or assist in general organizational tasks including open tasks and timelines and tracking of tasks
- Assist the audit of QC Laboratories (Chemistry, Microbiology) on a routine basis and report directly to department head
- Assist in writing/reviewing QA events/deviations/Investigation when required
- Interaction with QC Analysts and Group Leaders as well as managers of other departments as needed
- Able to work as a team member with the QC Lab environment
- Minimum Education: Bachelor’s degree or higher in scientific discipline required
- Minimum of 5+ years relevant work experience in Quality Assurance/Data review of QC in a pharmaceutical industry
- Experience in Clinical and commercial products is preferred
- Communicate with others clearly and concisely, ability to work in a fast-paced environment
- Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project etc. and Proofreading skills
- Knowledge of Quality Management Systems and LIMs systems
- Knowledge of current federal, local, and international regulations regarding the Testing, production and release of raw materials, drug substances and products. Excellent oral and written communication
- Ability to manage multiple priorities and re-prioritize tasks as required. Excellent problem-solving skills
- Ability to effectively train others on programs and procedures
- Experience working with cross-functional teams/sites
Sound exciting? Apply today and join our team!
Sutro Biopharma, Inc. requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Sutro will consider requests for reasonable accommodations.
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 every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability, or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together.
Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies.
The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be $95,000 – $115,000 (not including bonus, equity, and benefits). The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education.
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.