Senior Manager, External Quality Assurance (San Carlos, CA)

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.

Sutro has a unique capability that enables new molecular entities to be designed using a hybrid of synthetic and recombinant technologies to create best in class therapeutics in the oncology and auto-immune disease space. Our portfolio includes antibody-drug conjugates, bispecific antibodies, cytokine derivatives and other novel immuno-stimulatory approaches.

Sutro is actively pursuing a dynamic Quality customer-focused professional with working experience in areas including : audits and qualification of CMO/CTO organizations, product lot release of externally produced products, Quality records management and documentation control for externally produced products, project team participation and leadership.

Responsibilities

This individual will be responsible for supporting external supply chain cGMP operations at Sutro Biopharma and internal cGMP operations as needed and will, at a minimum, include:

• Perform lot release disposition of externally produced products
• Perform QA team leadership for specific product campaigns and CMC Team participation
• Lead investigation and resolution of cGMP or procedural compliance failures, as well as work CMO site leadership and partners to resolve compliance issues for externally produced products
• Drive the completion and maintenance of CMO/CTO Quality agreements
• Maintain an accurate list of all qualified suppliers, vendors, GMP service providers in support of Sutro San Carlos and external operations.
• Actively support the development, implementation, and maintenance of Sutro quality management systems, applicable SOP’s and qualification activities
• Perform reviews of cGMP documentation, both at Sutro and contract organizations
• Review and approve completed batch documentation for cGMP production, including QC documentation of release and in-process testing
• Lead investigation and resolution of cGMP or procedural compliance failures, as well as work with staff from other departments to resolve compliance issues found during the Quality review
• Release raw materials and batches/lots for further manufacturing, clinical trials and commercial distribution
• Perform Quality audits of potential and/or current vendors and contract organizations, as well as internal departments
• Oversee and perform training of personnel to ensure compliance and conformance to Sutro’s requirements
• Manage and perform day-to-day activities of the document control, including creation and/or revision, processing, routing and releasing controlled documents
• Provide QA support during manufacturing operations, which may include shift coverage
• Support contract Manufacturing operations as QA person-in-plant. Support QA management with various projects, as needed
• Develop, apply, revise and maintain quality assurance protocols and methods for processing materials into partially finished or finished products
• Design methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products
• Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary
• May assure compliance to in-house and/or external specifications and standards, (i.e. GLP, GMP, ISO, Six Sigma)
• May specialize in function specifically as it applies to biological licensing agreements
• Anticipated travel is approximately 5-20%

This individual will be expected to effectively follow Sutro Biopharma’s SOPs and policies, and cGMP compliance regulations. Additionally, the candidate should be able to independently manage review times to meet Sutro’s priorities and communicated timelines.

Qualifications

• 6+ years of Quality Assurance/Quality Systems related experience in a cGMP biologics regulated manufacturing environment is required
• Possess a working knowledge of 21 CFR FDA, EU and ICH guidelines
• Bachelor’s degree or higher in a relevant scientific area is strongly preferred
• Relevant Quality Systems experience including Supplier and CMO/CTO management, change control, documentation control, training and release
• Skilled in evaluating and implementing solutions for regulatory compliance guidelines
• Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities
• Knowledge and ability to sufficiently train others on regulatory compliance issues
• Strong interpersonal skills and ability to work with others in a positive “can do” and collaborative manner
• Balanced decision making that demonstrates critical thinking
• Able to establish priorities and maintain progress even under uncertain circumstances
• Strong verbal and written communication skills essential
• Strong communication, prioritization and organizational skills
• Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies
• Ability to utilize multiple word-processing and database applications 

Sound exciting? Apply today and join our team!

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.

Please be advised, inquiries or resumes from recruiters will not be accepted.

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.