Associate Director, Logistics Projects & Shipping Validation

$195,000 - $202,000/Yr

Vaxcyte - San Carlos, CA

Full-time - Senior

San Carlos, CA

Professional, Scientific, and Technical Services

About the position

The Associate Director, Logistics Projects & Shipping Validation at Vaxcyte is responsible for managing and conducting validation studies for pharmaceutical shipments, ensuring compliance with Good Manufacturing Practices (GMP) regulations. This role involves oversight of validation efforts across the supply chain, including Drug Substance, Drug Product, and Finished Drug Product, while providing technical support and guidance to various departments within the organization.

Responsibilities

• 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, and final reports for 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 and identify opportunities for process improvement.
• Contribute to the development of new validation methodologies and perform risk assessments post-validation to identify potential hazards and implement mitigation strategies.
• Interface with Quality, Process Development, Regulatory, MSAT, Commercial and other Supply Chain Teams.
• Establish strong relations with specialty shipping service providers, 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.

Benefits

• Competitive salary package
• Comprehensive benefits
• Equity component