The Staff Engineer will lead and manage engineering activities for advanced biotechnological systems, including utilities, process equipment, and automation. They are responsible for ensuring regulatory compliance, overseeing validation initiatives, and managing cross-functional projects from conception through commercial launch.
Lead the development of digital infrastructure, AI capabilities, and the commercial technology roadmap for the launch of VAX-31. Act as a strategic enabler across Marketing, Sales, Medical Affairs, and Market Access to reduce friction and increase operational leverage.
Lead enterprise-wide efforts to structure, govern, and utilize data and knowledge assets to support process development, clinical, and regulatory activities. Establish systems to capture institutional knowledge and ensure data integrity for commercial regulatory submissions.
Lead QA oversight for QC activities related to drug substances and polysaccharides across multiple global sites. Manage internal QA teams and external partners to ensure compliance with global regulatory guidelines and support vaccine pipeline development.
Lead and facilitate commercial process validation and risk management activities across end-to-end manufacturing processes. Coordinate technical strategies and cross-functional efforts to ensure commercial readiness and regulatory compliance.
Develop and execute global regulatory CMC strategies for investigational products and lead the preparation of regulatory submissions. Manage interactions with Health Authorities and provide regulatory guidance to cross-functional teams to ensure global compliance.
Lead launch readiness and commercial supply of polysaccharides for glycoconjugate vaccines, focusing on technical planning and regulatory filings. Coordinate cross-functional efforts to ensure process robustness and seamless transition from development to commercial manufacturing.
Serve as the CMC statistical lead for the Vaccine Specification Working Group, providing leadership for specification setting and justification across late-stage development and commercial lifecycle management. Collaborate with cross-functional teams to develop statistically sound, regulatory-ready approaches for drug substance and drug product testing.
The Associate Director will lead commercial process validation and risk management strategies across end-to-end manufacturing processes. This role involves cross-functional coordination to ensure regulatory compliance, successful technology transfer, and product lifecycle management.
The AI Implementation Consultant will support the design, evaluation, and implementation of AI solutions within the Legal and Compliance functions. This includes developing AI-powered tools, enhancing existing dashboards, and collaborating with cross-functional teams to drive efficiency and compliance.
