Sutro Biopharma, Inc. is seeking a versatile Sr. Manager or AD of Quality Control who 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. In addition, the ideal candidate is flexible to support Quality Assurance activities and has working knowledge of Quality Systems (QS) such as Training, Deviation Management, CAPA, Supplier Management and Documentation Control.
This individual will be responsible for supporting QC analytical operations in Sutro Biopharma’s cGMP Manufacturing Facility. Primary oversight will be analytical QC activities in support of release and stability testing and data review of Sutro Biopharma in-process and final product, QC oversignt for contract labs, 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 to ensure review is completed in a timely manner.
- 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 with emphasis on methods used to characterize antibody and antibody-drug conjugates.
- 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.
- Work closely within QC and cross-functionally 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 laboratory operations.
- Manage QC laboratory system (BioIT LIMS) and provide QC oversight to contract labs with investigation, OOS, trending data, and review and approval of changes to procedures.
- Complete deviation/OOS investigations as it relates to analytical QC testing, and implement CAPA and change controls.
- Actively participate in inspection readiness activities and be significantly involved in representing QC in inspections by regulatory agencies or partner companies.
- Actively create and establish processes and procedures to ensure cGMP compliance and operational efficiency within QC.
- Represent QC in cross-functional teams within Sutro.
- 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 MS degree in Chemistry or related field
- 10+ years of with BS or 8+ years with MS in QC management experience in a cGMP biologics regulated manufacturing environment is required
- Strong Techncial knowledge of QC methods- development, valiation, and life cycle and Stability Program
- Hands on experience on the QC testing, trouble shooting analytical instruments, and trending data
- Quality oversignt experience for contract labs and CMOs
- Working knowledge of antibody, antibody drug conjugates and protein analytical methods is strongly preferred
- Knowledge in 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.
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, and stock options.