Sutro Biopharma, Inc. is seeking a strategic seasoned Director of Quality Control who will lead by influence within a dynamic team environment to support phase appropriate GMP operations. 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 drug substance, as well as the management of 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. 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.
- 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 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.
- Pro-actively 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.
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.
- BS or MSdegree 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
- 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.