Senior Director, Quality Control (San Carlos, CA)
Sutro Biopharma, Inc. is seeking a strategic seasoned Senior Director of Quality Control who will lead and influence all Quality Control aspects for GMP Operations, internally and externally in all phases of product development including commercialization. Primary function will be accountability for all internal and external QC analytical and microbiology activities to support testing and data review of in-process and final release of Sutro products, as well as owning all stability programs. The candidate will have technical understanding of both analytical and microbiology analytical test methods including deep understanding of the analytical method transfer process. Excellent verbal and written communication skills are essential for success in this position including extensive experience negotiating with CTOs and CMOs. In addition, the ideal candidate has working knowledge of Quality Systems (QS) such as Training, Deviation Management, CAPA, Supplier Management and Documentation Control and more importantly the applicability of quality systems to the QC Area. The candidate must be able to strategically define and drive a multi-year plan and priorities for the QC function, internally and externally as build the technical and GMP skillset within the QC organization.
- Establish and drive strategy to ensure we are ready and compliant with late-stage Quality Control requirements including all Phase 2 and 3, EU including China.
- Accountable to all internal QC activities within San Carlos.
- Lead all QC Oversight activities for all external CMOs including overseeing all QC tech transfer activities.
- Consolidate and own all stability activities within Sutro (end-to-end) from raw materials, reagents, cell free, drug substance and drug product.
- Principal SME for QC sections of all Sutro regulatory submissions.
- Strategically establish a sustainable QC organization as evidenced by right-the-first time execution and independent technical and GMP capabilities.
- Accountable for all QC analytical and microbiology operations in Sutro Biopharma’s cGMP Manufacturing Facility and executed by external Contract Testing/Manufacturing Organizations.
- Establish credibility as the SME for all QC issues at Sutro Biopharma inside and outside the organization.
- Lead all testing activities within QC to support release and stability of drug linker, reagents, intermediates, drug substance and drug product.
- Provide subject matter expertise in the bioanalytical and microbiology QC methods such as HPLC, CE, IEF, ELISA, Bioburden, Endotoxin and compendial methods required for the release and stability testing of raw material, in-process, and final product. Experience with antibody and antibody-drug conjugates is highly preferred.
- Lead, establish and maintain 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.
- Possess extensive auditing experience in the Quality Control Area. Actively participate in inspection readiness activities and be significantly involved in representing QC in inspections by regulatory agencies or partner companies.
- Work closely within QC and cross-functionally representing QC with QA, Manufacturing, and tech transfer departments to ensure project timelines are met.
- Proactively identify and troubleshoot issues to prevent missed timelines and identify opportunities for improvement in QC analytical laboratory operations.
- Actively prepare and revise QC documents (protocols, reports, SOPs, special studies, etc.) as needed to support QC analytical and microbiology laboratory operations.
- Drive from End-to-End deviation/OOS investigations as it relates to analytical QC testing and implement CAPA and change controls.
- Actively create and establish processes and procedures to ensure cGMP compliance and operational efficiency within QC.
- Communicate data both verbally at group meetings and through written documents and reports.
- BS or MS degree in Chemistry or related field with working knowledge of Microbiology.
- 15+ years of with BS or 10+ years with MS in QC management experience in a cGMP biologics regulated manufacturing environment is required.
- Working knowledge of antibody, antibody drug conjugates and protein analytical methods is strongly preferred.
- Extensive experience establishing QC infrastructure and oversight for tech transfers to external CMOs.
- Knowledge in ICH/USP/EP/JP guidelines as it relates to QC methods, validation, and stability.
- Natural leader by influence that can educate and earn the credibility of associates up, down and across the entire organization and outside of the organization.
- Capable of strategic thinking that drives critical thinking and prioritization in the midst of a dynamic environment with multiple priorities.
- Excellent customer facing capabilities.
- 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.
- Strong verbal and written communication skills essential.
- Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.
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.