Associate Director, Logistics Projects & Shipping Validation

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, periodontitis 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: The Associate Director, Logistics Projects & Shipping Validation is responsible for conducting and managing validation studies for pharmaceutical shipments to ensure compliance with Good Manufacturing Practices (GMP) regulations. This role involves oversight of designing, executing, and documenting validation studies for air, over-the-road, and temperature-controlled conditions, as well as providing technical support and guidance to the organization. Essential Functions: Lead all Shipping validation efforts across the entire supply chain including Drug Substance, Drug Product, Finished Drug product and other materials as required. Manage consultants and lead cross-functional teams to deliver validation projects including: Defining scope and master plans Performing risk assessments Writing protocols Conducting simulation studies Executing PQ shipments Data analysis & trend identification Risk Identification & Mitigation Plans Final Reports BLA submissions Ensure that validation studies adhere to GMP regulations and industry standards. Provide technical support and guidance to other departments on GMP compliance and validation matters. Assist in streamlining shipping procedures. Identify opportunities for process improvement and contribute to the development of new validation methodologies. Post validation, perform risk assessments to identify potential hazards and implement mitigation strategies to minimize risk. Interface with Quality, Process Development, Regulatory, MSAT, Commercial and other Supply Chain Teams. Establish strong relations with specialty shipping service providers (Biocair, World Courier, etc.), freight forwards, 3PLs. and other consultants. Lead or support other supply chain related projects as needed. Requirements: BA/BS degree in a related field required. Minimum of 10 years’ experience with 5 years in the life sciences industry. 5 years’ experience with international cGMP cold chain shipping and regulatory guidelines required. Experience in conducting validation studies for transportation processes in a regulated environment. Fluent with all global shipping-related statutory and regulatory requirements. Understand the requirements, technologies, and processes of cold-chain supply management. Experience with existing logistic service providers with knowledge of prequalified active and passive containers. Experience with arranging international and domestic transportation. Experience authoring and using GxP documents such as SOP’s and work instructions. Relentless focus and passion around process improvements (efficiency and automation). Excellent communication, customer service, and relationship skills are an absolute must. Reports to: Executive Director, Global Supply Chain Location: San Carlos, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary Range: $195,000 – $202,000 (SF Bay Area). Salary ranges for non-California locations may vary. Vaxcyte, Inc. 825 Industrial Road, Suite 300 San Carlos, CA 94070 We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.