Associate Director, Quality Control Analytical (San Carlos, CA)
Sutro Biopharma, Inc. is seeking a driven and talented individual to join our Quality team as we change the future of oncology. The Associate Director of Quality Control Analytical will work independently within a dynamic team environment to support GMP operations. Primary function will be oversight of QC analytical activities to support testing and data review of in-process and final drug substance as well as the management of the internal stability program. The position will also be required to write protocols and reports, participate in deviation/OOS investigations, and implement CAPAs and change controls per GMP requirements as needed. Excellent verbal and written communication skills are essential for success in this position.While collaborating with cross-functional departments, you will play a key role in maximizing our technology and progressing our novel therapeutics. We are dedicated to making a difference in the lives of patients, both as individuals and as part of a team.
This individual will be responsible for leading QC analytical operations in Sutro Biopharma’s cGMP Manufacturing Facility. Primary oversight will be analytical QC activities in support of release and stability testing of Sutro Biopharma in-process and final product, and will, at a minimum:
- Manage, coordinate, and prioritize the analytical testing function within QC to support release and stability of reagents, intermediates, and final product.
- Manage and perform analytical assay data review and approval.
- Provide subject matter expertise in the bioanalytical QC methods such as HPLC, CE, IEF, ELISA, and compendial methods required for the release and stability testing of raw material, in-process, and final product.
- Oversee and manage the internal stability program and ensure on-time test completion, on-time data review, and real-time monitoring of stability data. Prepare stability protocols and interim stability reports.
- Drive and manage method transfer activities to QC for new molecules.
- Proactively identify and troubleshoot issues to prevent missed timelines and identify opportunities for improvement in QC analytical laboratory operations.
- Exercise judgment within broadly defined practices and procedures to determine appropriate action.
- Actively prepare and revise QC documents (protocols, reports, SOPs, special studies, etc.) as needed to support QC analytical laboratory operations.
- Complete deviation/OOS investigations as it relates to analytical QC testing and implement CAPA and change controls as needed to improve compliance.
- Actively participate in inspection readiness activities and establish processes and procedures to ensure cGMP compliance and operational efficiency within QC.
- Work closely within QC and cross-functionally with Analytical Development, QA, Manufacturing, and Tech Transfer departments to ensure project timelines are met.
- Thisexpected to effectively follow Sutro Biopharma’s SOPs and policies, and cGMP compliance regulations.
- He/she should be able to independently manage review times to meet Sutro’s priorities and communicated timelines.
- PhD in scientific discipline plus 10+ years’ experience or BS/MS in scientific discipline plus 15+ years’ experience in pharmaceutical/biotech.
- 5+ years of QC management experience in a cGMP regulated manufacturing environment.
- Working knowledge of analytical methods for large molecules including protein characterization assays.
- Working knowledge of ICH/USP/EP guidelines as it relates to QC methods, validation, and stability.
- Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
- 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.
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.