QC Laboratory Manager (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 Laboratory Manager will report to the Director of Quality Control and will be responsible for ensuring compliance with QC and QA quality systems, maintaining oversight of laboratory staff and day-to-day laboratory activities, supporting operations, instrument maintenance/calibration, special projects, and supporting other parts of the business as needed. This position will require advanced knowledge of pharmaceutical dosage forms in commercial and clinical phases, PGood Manufacturing Practices (cGMP), Out of Specification (OOS) issues handling, Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), Analytical Testing Methods, as well as being familiar with FDA, EMA and ICH laboratory requirements. Capable of driving method development/validation/transfer projects.  While collaborating with cross- functional departments, this will be key role in maximizing our technology and progressing our novel therapeutics to next phases.

Responsibilities

  • Manages and is responsible for the day-to-day operations and success of the QC Laboratory including sample processing/intake, microbiology, and chemistry sections
  • Monitors productivity and time management of Release, In-process, and Stability testing to ensure laboratory is meeting benchmark metrics. Maintains oversight of testing volume to ensure service standards are met, including lab sample turnaround
  • Identifies problems (both personnel and technical) that may adversely affect test performance or reporting of test results and determines solutions while collaborating with Laboratory Management
  • Partners with Manufacturing/MSAT to anticipate workloads and overall efficiencies of the laboratory and represents QC in cross-functional meetings and projects regarding internal laboratory testing
  • Implements programs, processes, and operational improvements to enhance the level of internal Sutro Laboratory testing turnaround
  • Assist in the development and maintain compliance of SOPs, forms, and other laboratory documentation, policies, and procedures as well as instrument calibration and maintenance
  • Participates in conjunction with QC Leads/Managers, Quality Assurance, and the QC Director in implementation of cGMP, FDA and EMA, USP and EP, ICH, and ISO regulations and guidelines to ensure laboratory is compliant and current
  • Coordinates with Laboratory Director for the use of laboratory personnel and equipment for the execution of special projects and testing that falls outside the regular scope of QC testing and procedures
  • Assists Laboratory Management to select and schedule with outside vendors, purchase of equipment and contracts for services, acts as point of contact for preventative maintenance and calibration contracts
  • Assists in the evaluation of new instrumentation and/or methods as required to improve laboratory testing performance and may oversee the troubleshooting/problem-solving of instruments and methods
  • Aid in the development, implementation, and communication of departmental mission, vision, and strategic plan
  • Experience writing and reviewing regulatory dossiers
  • Experience participating in client and regulatory inspections

Qualifications

  • Minimum Education: Bachelor’s Degree in scientific discipline required.
  • 8+ years of experience working in a laboratory environment with 2+ years of management experience preferred
  • Experience in Clinical and commercial products is preferred
  • Advanced knowledge of pharmaceutical testing applications for microbiological or chemical analysis of API through experience or education preferred
  • 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
  • Proficient with using Quality tools such as FMEA, Fishbone, Process flow chart, etc.
  • Maintains a level demeanor in stressful situations and possesses skills to mitigate issues
  • Proficient with 21 CFR 58 and 211, ICH Q7, Q9, Q10, USP <795>, USP <797>, USP <800>
  • Advanced knowledge of scientific principles and concepts with strong mathematical and reasoning ability, with knowledge of pharmaceutical APIs and dosage forms
  • Advanced critical thinking skills and the ability to work collaboratively with other departments to resolve complex issues with innovative solutions
  • Possesses strong verbal and communication skills, attention to detail, time management skills, exceptional observation skills, organization, and thorough documentation
  • Demonstrates leadership skills including the ability to effectively develop, assist, train, and coach laboratory personnel
  • Demonstrated knowledge in managing and improving laboratory operations, personnel safety, and quality
  • Demonstrated success in leading laboratory operations to achieve improved performance and profitability
  • Willingness to adapt to changing environment and support the current business needs

Sound exciting? Apply today and join our team!

Please submit resume for Req. # 23-400-002N to jobs@sutrobio.com. Please visit our website at www.sutrobio.comfor more information.

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 $135,000 – $160,000 (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.

Company Overview

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.