Stability Manager

Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values: *RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered. *AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. *LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. *MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making. Summary: Vaxcyte is looking for an energetic and talented individual to join Vaxcyte’s Vaccine Product Development organization as a Stability Manager within the Quality Control Unit. The primary function of this level position is to manage the stability program for various projects in preclinical and clinical development. The position will be an integral part of the team implementing and maintaining cGMP Stability for all phases of clinical development. Primary responsibility will include managing stability studies for individual projects and stability data analysis. This individual will collaborate with QC members in a highly collaborative and cross-functional environment. The ideal candidate will apply strong stability experience, ensure compliant operations and documentation, foster open communication, and pursue data-driven approaches. Essential Functions: • Designs, coordinate, and execute stability studies for early and late-stage vaccine products according to regulatory guidelines and company protocols. • Summarize vaccine stability results by applying analytical testing expertise to ensure scientific and technical excellence. Utilize statistical software like JMP to perform rigorous statistical analyses, ensuring robust interpretation of data and adherence to regulatory standards. • This includes, but not limited to, creating, implementing, and managing stability databases, performing data trending and statistical analysis, study and testing forecasting and reporting of metrics, creation, revision and approval of SOP's, stability protocols and reports in accordance with current GMP, FDA, EU, Global and ICH guidelines and regulations. • Produce impactful PowerPoint presentations to effectively communicate stability data to diverse project team members. Support the attainment of project milestones by facilitating stability monitoring and determining expiration dates for clinical and in-process materials. • Authors, reviews, revises, and approves SOP's, stability protocols and reports, memo’s, regulatory and specification documents (as required). • The Stability Manager will also assist with leading the functionality and maintenance of stability related processes and systems. • Drives continuous improvement activities for the clinical stability programs. • Ensures that the GMP stability program continuously aligns with FDA, ICH and other international agencies. • Manages Quality Systems records for QC Stability- creates, assesses, reviews Deviations, Change Controls