Sutro Biopharma, Inc. is looking for energetic and talented individual to join its Quality Control team based in San Carlos, CA. You will be working to support the daily operations of the Quality control group, while supporting the development of new processes which maximize our technology and enhance our internal and collaborative product development initiatives in a fast-paced environment.

Responsibilities:

• Assist and manage all critical analytical method projects for new and existing proprietary and partner programs.
• Work with QC and AD teams in the completion of critical projects associated with analytical methodology.
• Collaborates with QC senior management and cross-functional departments to design, implement, and oversee Method Transfer and Method Qualification activities. The development of Transfer/Qualification protocols to evaluate and demonstrate method suitability per ICH. FDA, and EMA guidelines.
• Overseeing the execution of all Method Transfer, Qualification, and Validation protocols executed internally – ensure the timely execution, report approval, and SOP effectiveness to meet department timelines.
• Review and provide recommendations to CMOs/CTLs for protocols, reports, and methods originating from the Sutro QC department.
• Participate and lead Method Transfer Activities to CTLs/CMOs from Sutro QC.
• SME in a variety of analytical assays with leadership skills to assist junior staff with troubleshooting and method lifecycle issues.
• Collaborate with the internal Analytical Development department to design and support transfer/qualification/validation activities.
• Collaborate with the internal Analytical Development department to design and support method lifecycle activities.
• Collaborate with Quality Assurance to review and approve documents associated with all quality control activities.
• Trend and interpret analytical data and propose decisions to management for method lifecycle improvements.
• Provide support during inspection and regulatory audits with emphasis on method Transfer, Qualification, and Validation activities.
• Draft and review QC-analytical documents (SOPs, Protocols, Reports etc).
• Collaborate with external partners and RA to provide analytical data in support of regulatory filings and annual reports.
• Develop and maintain critical reagent inventory necessary to complete analytical quality control activities.
• Prepares method summary reports, trending plots, with periodic updates to leadership or external partners in support of analytical method lifecycle.

Qualifications:

• BS in chemistry, biochemistry, bioanalytical Chemistry, or scientific-related field with a minimum of 6 years of industry-related experience or MS degree in the same fields as above with 3-5 years of industry experience.
• Demonstrated expertise in the testing of raw materials and Antibody Intermediates, for clinical and phase II/beyond programs.
• Extensive knowledge of HPLC, Electrophoresis, ELISA, UV spectroscopic methods, and compendial methods.
• Demonstrated experience in a GMP Quality Control environment.
• Experience with regulatory and partner audits is preferred.
• Excellent interpersonal, organizational, written, and oral communication skills
• Excellent interdepartmental collaboration management skills
• Demonstrated expertise with cGMP applicable to pharmaceutical settings and with method verification/validation concepts.
• Positive team-oriented can-do-attitude.
• Ability to operate in a fast-paced laboratory environment and adapt to changing assignments.
• Ability to oversee critical QC projects to completion while driving and motivating a team.

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.

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 $100,000 - $125,000 (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.