Sr. Quality Assurance Specialist, Manufacturing

Sutro Biopharma, Inc. is looking for energetic and talented individuals to join its multidisciplinary research and development & clinical manufacturing team. You will be working to enhance our internal and collaborative product development initiatives in a fast-paced environment.

Strong organizational skills and the ability to prioritize work in a timely manner is a critical requirement of this position. You must be able to work the following hours: 0700-1500, Monday through Friday.

The Senior Quality Assurance Specialist reports to the Sr. Manager, Quality Operations.

Responsibilities:

This individual will be responsible for supporting Quality Operations (QO) in Sutro Biopharma’s cGMP Manufacturing Facility and will, at a minimum, include:

• Conducting on the floor Quality reviews of production documentation, including production batch records, analytical records and any supporting documentation to ensure compliance with cGMPs and Sutro policies and procedures, and in some cases prepare disposition documentation.
• Performing routine reviews of all cGMP documentation, to include laboratory notebooks, equipment logs and facility monitoring reports. Additionally, create and/or utilize various databases to track compliance issues and their resolution.
• Providing QA support during manufacturing operations.
• Assist with investigation and resolution of cGMP or procedural compliance gaps, as well as work with staff from other departments to resolve compliance issues found during the Quality reviews.
• Perform Area Changeover in Manufacturing areas.
• Interpret generated data and communicate results to Quality Management.
• Maintain effective communication and partnership with Operations.
• Performs 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 assist/support in Quality Systems activities including Documentation Control, Training Supplier Management and Raw Material/Product Release.
• May assist in driving initiation, execution, closure and trending of Change Controls, Deviations, and CAPAs in support of San Carlos Manufacturing Operation.
• May assist with training of personnel, to ensure compliance and conformance to Sutro’s requirements.

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

This individual may be asked to travel on behalf of Sutro Biopharma to support business operations that involve contract manufacturing. Travel is not expected.

Qualifications:

• 5 - 8 years of Quality Assurance On-The-Floor or Biologics manufacturing-related experience required.
• Experience in a cGMP-regulated facility is required.
• Bachelor’s degree or higher in a relevant scientific area is strongly preferred.
• Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.
• Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
• Results self-driven with a “can do” positive attitude
• Knowledge and ability to sufficiently train others on regulatory compliance issues
• Strong interpersonal skills and ability to work with others in a positive and collaborative manner
• Strong verbal and written communication skills essential
• Strong communication, prioritization, and organizational skills
• Strong attention to detail
• Knowledge of cGMP concepts and guidelines, as well as good documentation practices
• Ability to utilize multiple word-processing and database applications. Experience with contract manufacturing operations is a plus.

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 $110,000 – $130,000 (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.