Senior Director of Global Logistics and Distribution

Join Our Mission to Safeguard Humanity!At Vaxcyte, we are pioneering vaccine innovations aimed at developing high-fidelity vaccines to combat the dire consequences of bacterial diseases. These diseases pose significant health risks and financial burdens if not addressed. Our commitment extends to eradicating or treating various bacterial infections, including invasive pneumococcal disease, Group A Strep, and Shigella. We have a clear and strategic path to success, positioning Vaxcyte for long-term achievement. Our Approach: We believe that WHAT we do is equally important as HOW we do it! Our collaborative efforts are underpinned by four enduring core values: *RETHINK CONVENTION: We infuse creative and intellectual diversity into every aspect of our work to innovate and continuously improve the delivery of vaccines. *AIM HIGH: Together, we strive toward an ambitious goal of developing the most complex biologics to safeguard humanity. *LEAD WITH HEART: At Vaxcyte, we foster a kindness-first, inclusive approach to leadership, promoting collaboration and open debate that drives our business objectives forward. *MODEL EXCELLENCE: The scale of our challenges calls for a shared commitment to integrity, accountability, equality, and clarity in our communications and decision-making processes.Position Summary:The Senior Director of Global Logistics and Distribution will oversee the shipping and storage of all Vaxcyte CMC materials, including finished goods, bulk products, and samples. This role encompasses materials for Research, Development, Clinical, and Commercial purposes and will report directly to the Executive Director of Global Supply Chain.Key Responsibilities:Strategic Planning:Formulate and execute a global logistics and distribution strategy that aligns with corporate goals, including network design, transportation optimization, and warehousing operations.Operations Management:Guarantee the efficient, timely, compliant, and high-quality delivery of all materials within scope.Ensure robust pack-out designs with appropriate containers and components to maintain materials at target temperatures and facilitate efficient receipt.Establish strong shipping agreements with CMOs and suppliers to ensure seamless operations.

Join Our Mission to Safeguard Humanity!Vaxcyte is at the forefront of clinical-stage vaccine innovation, dedicated to developing high-fidelity vaccines aimed at protecting humanity from the serious and costly implications of bacterial diseases. Our commitment to eradicating or treating infections such as invasive pneumococcal disease, Group A Strep, and Shigella exemplifies our mission. With a clear and well-defined path to success, Vaxcyte is poised to make a significant impact. Our Approach: At Vaxcyte, what we do is as crucial as how we do it. Our collaboration is anchored in four enduring core values: *Rethink Convention: We infuse creativity and diverse thinking into every aspect of our work to continuously innovate how vaccines are delivered. *Aim High: We embrace our bold collective goal to courageously develop the most complex biologics ever attempted to safeguard humanity. *Lead with Heart: Every individual at Vaxcyte leads with a kindness-first, inclusive approach that fosters collaboration and vigorous debate to advance our business objectives. *Model Excellence: The scale of our challenge necessitates a shared commitment to integrity, accountability, equality, and transparency in communication and decision-making.Position Overview:The Associate Director of Quality Control Operations is a pivotal executive role within our global vaccine organization. This position is responsible for implementing Vaxcyte's analytical strategies at our Contract Development and Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs). Acting as the primary liaison for our CDMOs and CROs, you will ensure the delivery of high-quality, accurate, and compliant testing and analytical services. Collaborating closely with the analytical technical lead and various functions—including Analytics, Process Development, Manufacturing Science, Quality Assurance, and Regulatory Affairs—you will provide leadership and oversight for the execution of analytical strategies supporting analytical readiness and deliverables. You will be accountable for ensuring timely and compliant testing and release at our CDMO and CRO, facilitating a secure and uninterrupted supply of Vaxcyte’s groundbreaking therapies.

Join Our Mission to Protect Humanity!Vaxcyte is a pioneering clinical-stage vaccine innovation firm dedicated to engineering high-fidelity vaccines designed to safeguard humanity against the dire and costly consequences of bacterial diseases. Our mission extends to eradicating or treating bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella—this is merely the start of our journey. With a clear and well-defined path to success, Vaxcyte is poised to make a significant impact. Our approach is as crucial as the outcomes! Our collaborative efforts are anchored by four fundamental core values: *RETHINK CONVENTION: We infuse creativity and intellectual diversity into every aspect of our work, continuously innovating the delivery of vaccines. *AIM HIGH: We passionately pursue our ambitious goal to develop the most complex biologics ever attempted for the protection of humankind. *LEAD WITH HEART: At Vaxcyte, everyone is a leader, embracing a kindness-first, inclusive approach that fosters collaboration and robust debate to advance our business objectives. *MODEL EXCELLENCE: The magnitude of our challenges necessitates a collective commitment to integrity, accountability, equality, and transparency in our communications and decision-making.Position Overview:The Director of Drug Substance (DS) Commercialization for Critical Raw Materials will spearhead the launch readiness and commercial supply of essential raw materials for the production of engineered Critical Raw Materials (eCRM) and related components for glycoconjugate vaccines. This role encompasses serving as the technical lead and Subject Matter Expert (SME) on biologic raw material processes. The primary focus is on technical launch planning and execution, utilizing best practices while coordinating cross-functional efforts for regulatory submissions, facility readiness, launch supplies, and post-launch process robustness initiatives.This position also involves providing leadership to ensure effective communication regarding the scientific and commercial rationale behind critical raw material manufacturing processes to internal stakeholders, Contract Manufacturing Organizations (CMOs), and regulatory agencies. The incumbent will collaborate with the organization to guarantee timely execution and meticulous planning for commercial lifecycle management.This position reports to the Senior Director of Global DS Commercialization, Protein.

About AetherfluxAetherflux is at the forefront of addressing the global energy challenge through innovative infrastructure for abundant, resilient, and continuous space-based solar energy. Our world-class team is dedicated to revolutionizing the way civilization powers, computes, and connects, from orbit to Earth.Position OverviewAs the Lead Software Engineer for Distributed Systems at Aetherflux, you will spearhead a talented software team focused on the development and maintenance of real-time constellation management and computational tasking architecture. Your leadership will ensure the overall quality, reliability, and fault tolerance of our ground systems software infrastructure, which encompasses satellite control, power beaming operations, compute cloud management, and ground receiver systems. You will also play a crucial role in mentoring and growing a team of software engineers, establishing development standards, leading architecture and code reviews, and implementing robust software practices to support Aetherflux's space-based power transmission and orbital computing platforms.Key ResponsibilitiesTeam Leadership: Oversee and guide the ground software team in developing mission-critical constellation and compute management software, while fostering mentorship, performance management, and career growth.Project Management: Strategically plan and coordinate code releases, including task breakdowns, sprint management, timeline tracking, and stakeholder communication.System Architecture: Design and lead the development of distributed systems aimed at achieving fault tolerance and high performance for mission-critical operations.Cloud Infrastructure Development: Lead the design and development of real-time scheduling systems, data pipelines, collision avoidance systems, and high-performance compute services.Testing & Simulation: Collaborate with hardware and test teams to create software-in-the-loop (SITL) and hardware-in-the-loop (HITL) environments for validating software performance during on-orbit maneuvers and ensuring constellation health.

Become a Champion for Global Health!At Vaxcyte, we are at the forefront of vaccine innovation, developing cutting-edge vaccines designed to combat the severe and costly impacts of bacterial diseases. Our mission is to eliminate or effectively manage bacterial infections, including invasive pneumococcal disease, Group A Streptococcus, and Shigella. We have a clear trajectory towards success, and Vaxcyte is well-equipped to achieve our ambitious goals. Our Approach: What we do is equally as significant as how we accomplish it! Our collaborative efforts are driven by four core values: *RETHINK CONVENTION: We introduce creativity and diverse perspectives into every aspect of our work to innovate and continuously improve vaccine delivery methods. *AIM HIGH: We strive for excellence with a bold ambition to create some of the most intricate biologics ever developed to safeguard human health. *LEAD WITH HEART: Kindness and inclusivity are at the forefront of our leadership style, fostering collaboration and robust discussions that propel our business forward. *MODEL EXCELLENCE: We share an unwavering commitment to integrity, accountability, and clarity in all our communications and decisions.Position Overview:Vaxcyte is in search of a Senior Director, Product Launch Lead for VAX-31, who will spearhead the strategic planning and execution of our inaugural launch. This pivotal role involves coordinating cross-departmental initiatives from late-stage development through market introduction, ensuring readiness across supply chain, regulatory, medical affairs, and commercial operations. You will collaborate with senior leadership to outline launch strategies, manage timelines, address risks, and synchronize efforts among internal and external stakeholders to successfully introduce our products to the global market.

As a Senior Director of Oncology Clinical Trial Operations at Natera, you will lead and optimize our clinical trial operations in the oncology space, ensuring the successful execution of clinical studies from inception to completion. You'll collaborate with cross-functional teams to develop innovative strategies that align with our mission to improve patient outcomes through precision medicine.Your leadership will be pivotal in managing a team of dedicated professionals, fostering a culture of excellence and continuous improvement. The ideal candidate will possess a deep understanding of oncology clinical trials, regulatory requirements, and an ability to navigate complex project landscapes.

Global Supply Manager, Structures | Supply ChainLocation: San Carlos, CA (on-site)About 1XAt 1X, we are at the forefront of innovation, building humanoid robots that collaborate with humans to address labor shortages and foster a future of abundance.Role OverviewWe are in search of a dedicated Global Supply Manager to lead the global sourcing of structural components such as frames, enclosures, and pivotal structural systems. Your contributions will be crucial in establishing a robust and scalable supply chain that ensures the reliable production of our next-generation humanoid robots.Key ResponsibilitiesFormulate and implement sourcing strategies for structural components, encompassing metals, plastics, and composites.Identify, assess, and onboard global suppliers that fulfill our stringent quality, cost, and delivery criteria.Negotiate contracts, pricing, and delivery terms to secure advantageous agreements.Collaborate with engineering teams to ensure parts meet both mechanical and aesthetic specifications.Support initiatives aimed at cost optimization while maintaining durability and consistency.Conduct supplier benchmarking and stay abreast of technology and pricing trends.Monitor supplier performance metrics to ensure adherence to contractual obligations.Implement risk mitigation strategies, including alternate sourcing and diversification.Provide technical support for Design for Manufacturing (DFM) efforts with an emphasis on structural systems.Manage supplier audits and drive continuous improvements where necessary.Work collaboratively with manufacturing, operations, and quality teams to ensure seamless integration.

Join Our Mission to Safeguard Humanity!Vaxcyte is at the forefront of vaccine innovation, dedicated to developing high-fidelity vaccines aimed at protecting humanity from serious bacterial diseases. Our commitment to eradicating or effectively treating infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. With a clear and well-defined path ahead, Vaxcyte is positioned for long-term success. Our approach is defined by our core values: *RETHINK CONVENTION: We embrace creative and intellectual diversity to innovate and continuously improve vaccine delivery. *AIM HIGH: We pursue our collective audacious goal of developing the most complex biologics to protect humanity. *LEAD WITH HEART: At Vaxcyte, we lead with kindness and inclusivity, fostering collaborative discussions that propel our business objectives. *MODEL EXCELLENCE: Our significant challenges demand a shared commitment to integrity, accountability, equality, and clear communication.Role Summary:The Senior Manager for Drug Substance (DS) Commercialization will oversee the launch readiness and commercial supply of the conjugate drug substance. This role will facilitate the transition of the conjugate product strategy from the Process Development team to Manufacturing Science and Technology (MSAT) during the late stages of product development. Key responsibilities include technical launch planning and execution, implementing best practices, and coordinating cross-functional efforts for regulatory submissions, facility preparations, and launch materials.The successful candidate will provide leadership to ensure effective communication of the scientific and commercial rationale for the conjugation process to internal stakeholders, relevant Contract Manufacturing Organizations (CMOs), and regulatory bodies. Exceptional written communication skills are essential, particularly in authoring submissions to Health Authorities (IND/BLA). The ability to collaborate with individuals from diverse backgrounds and perspectives is crucial for success in this role.

As the Director of Deployment at robust.ai, you will play a critical role in the successful implementation of our cutting-edge artificial intelligence solutions. You will lead the deployment team to ensure seamless integration of our technologies into client environments, driving operational excellence and delivering exceptional customer experiences.

About You and This Role:Robust AI is an innovative and rapidly expanding startup, established in 2019 by a remarkable team with extensive expertise in robotics, artificial intelligence, and business. We pride ourselves on our collaborative culture, where diverse backgrounds and perspectives are valued. We are on the lookout for passionate individuals who share our enthusiasm for robotics and AI, as we strive to redefine the core principles of robotics and create intelligent, collaborative, robust, safe, flexible, and genuinely autonomous robots.As the Director of Perception, you will spearhead our initiatives in computer vision and sensing, driving the development of resilient, real-world robotic systems. You will be responsible for building and leading a world-class team dedicated to enabling our robots to perceive, comprehend, and engage with intricate, dynamic environments. This role demands a rare combination of technical expertise, strategic foresight, and exceptional leadership skills. You thrive in a fast-paced startup environment and are adept at adapting to evolving challenges.

Global Supply Manager, Motors & Magnets | Supply ChainLocation: San Carlos, CA (on-site)About 1XAt 1X, we are at the forefront of innovation, creating humanoid robots designed to collaborate with humans in tackling labor shortages and fostering abundance in various industries.Position OverviewWe are on the lookout for a skilled Global Supply Manager who will spearhead the sourcing and supply chain strategies for motors, gearboxes, and magnetic assemblies essential for the high-performance and scalable production of our advanced humanoid robots.Key ResponsibilitiesFormulate and implement effective sourcing strategies for motors, gearboxes, magnets, and associated components.Identify, assess, and onboard international suppliers that align with our quality, cost, and delivery benchmarks.Negotiate terms of contracts, pricing, and delivery schedules to ensure advantageous agreements.Collaborate with engineering teams to confirm that components meet performance and quality standards.Drive initiatives for cost optimization while maintaining high reliability and performance.Conduct thorough supplier benchmarking and stay updated on technological advancements and pricing trends.Track supplier performance metrics, ensuring compliance with contractual obligations.Develop risk mitigation strategies, including alternative sourcing and diversification plans.Provide technical assistance for Design for Manufacturability (DFM) initiatives focusing on electromechanical systems.Oversee supplier audits and implement necessary improvements.Work closely with manufacturing, operations, and quality assurance teams to ensure seamless integration.

Join Our Mission to Safeguard Humanity!Vaxcyte is a pioneering clinical-stage vaccine innovation enterprise dedicated to engineering high-fidelity vaccines aimed at protecting humanity from the dire consequences of bacterial diseases. Our efforts to eradicate or treat significant bacterial infections, including invasive pneumococcal disease, Group A Strep, and Shigella, are just the beginning. With a clear and well-defined path to success, Vaxcyte is poised to make a lasting impact. Our Approach is as crucial as Our Mission! We are guided by four core values that shape our collaborative efforts: *RETHINK CONVENTION: We embrace creative and intellectual diversity to innovate and continuously improve vaccine delivery methods. *AIM HIGH: Our audacious goal drives us to develop the most complex biologics ever devised to protect humankind. *LEAD WITH HEART: Collaboration and vigorous debate are fostered through a kindness-first, inclusive approach. *MODEL EXCELLENCE: Our challenge requires a shared commitment to integrity, accountability, equality, and clear communication in decision-making.Position Summary:Vaxcyte is looking for a distinguished Director of Immunoassay Development to spearhead and lead a dedicated analytical function focused on immunoassay development for intricate conjugated vaccines. This role will involve building and managing a laboratory team tasked with the development, maintenance, and continuous enhancement of potency- and antigenicity-based immunoassays to support CMC development from preclinical stages through BLA-stage programs and commercialization.A primary focus for this role will be the stewardship of the VAX-31 MSD immunoassay platform, which has advanced to Phase 3 due to extensive internal leadership in clinical serology, GLP studies, and immunoassay development. The ideal candidate will collaborate closely with the current immunoassay leadership to ensure effective knowledge transfer, maintain scientific and execution excellence, and ensure the long-term sustainability of the immunoassay strategy as accountability transitions into Analytical Development.This is a hands-on scientific leadership position embedded within CMC execution.

About Obvio AIEvery year, over 7,500 pedestrians lose their lives due to traffic incidents in the U.S., a staggering 70% increase over the last decade. Despite heightened awareness, many cities are still grappling with the challenge of reducing dangerous driving behaviors. Our 'Vision Zero' initiatives are proving inadequate.At Obvio AI, we are dedicated to changing this narrative.We utilize solar-powered, AI-driven cameras to enforce traffic regulations in areas where pedestrians are most at risk, automating enforcement in ways that traditional systems or police forces cannot achieve. Our innovative approach has already resulted in significant reductions in reckless driving, enhancing safety for pedestrians, drivers, and law enforcement alike.Founded by the same team that developed Motive's AI dashcam, we are supported by Bain Capital Ventures and Khosla Ventures. Recently, we secured $22M in Series A funding and are collaborating with some of the most progressive cities in the nation. With substantial revenue, a vast market opportunity, and a strong policy push, we are laying the groundwork for safer streets worldwide.Obvio is on the lookout for its inaugural Engineering Director to spearhead two of our pivotal product teams—Ticketing and Platform—at a crucial juncture in our growth journey. You will be responsible for the core systems that underpin our mission: the portals used daily by law enforcement and drivers, the external integrations with government and processing systems, the payment infrastructure vital to our operations, and the cloud foundation upon which our entire engineering organization relies.Our existing systems were designed for rapid scalability to get us where we are today. Now, with our momentum, it's time to evolve them into robust infrastructure that can keep pace with our ambitions. This role demands a blend of operational excellence and architectural foresight: someone who can ensure smooth operations today while strategically laying the groundwork for tomorrow. If you have navigated engineering through a hypergrowth phase and have the experiences to show for it, we are eager to connect with you.

Director of FacilitiesAbout AetherfluxAetherflux is at the forefront of addressing the global energy crisis by pioneering the infrastructure necessary for abundant and resilient space-based solar energy. Our dedicated team is tackling one of humanity’s most intricate engineering challenges, committed to revolutionizing power platforms that transform how civilization powers, computes, and connects—bridging the gap from orbit to Earth.Founded by Baiju Bhatt in 2024, inspired by his father’s contributions at NASA Langley Research Center, Aetherflux is driven by innovation. With a B.S. in Physics and M.S. in Mathematics from Stanford, Baiju co-founded Robinhood, now a public entity that has empowered over 20 million Americans to access financial services. To date, Aetherflux has successfully raised $90 million from esteemed investors including Index Ventures, Interlagos, Construct Ventures, Breakthrough Energy Ventures, and Andreessen Horowitz.Our mission is ambitious, demanding extraordinary talent. Our team comprises professionals from leading organizations such as SpaceX, NASA, and the U.S. Navy, all based in San Carlos, CA. If you are eager to tackle complex technical challenges and contribute to building the world's most vital energy company, we invite you to join us.Position OverviewWe are searching for a seasoned Director of Facilities to spearhead the strategy, development, and management of our facilities, which encompass satellite manufacturing areas, cleanrooms, integration and test environments, laboratories, mission operations spaces, and corporate offices. This pivotal role will ensure that our facilities facilitate high-reliability hardware production, comply with aerospace and export control standards, and efficiently scale as we move towards full operational capacity.

Role overview Natera is hiring an Associate Director of Biostatistics to join the team in San Carlos, CA. This leadership position oversees a group of biostatisticians and partners with colleagues from multiple departments. The main focus is on designing and analyzing clinical trials that support projects in genomic testing and personalized medicine. What you will do Supervise and mentor a team of biostatisticians Work with cross-functional teams to plan and analyze clinical trials Use statistical programming and analysis methods in healthcare research Contribute statistical data for regulatory submissions Impact This position plays a key role in advancing genomic testing and personalized medicine. The work aims to improve patient care by providing data-driven insights that inform healthcare decisions.

Director of Compute SoftwareAbout AetherfluxAt Aetherflux, we are revolutionizing the infrastructure that powers and connects the orbital economy. Our innovative modular satellites harness sunlight in Low Earth Orbit, facilitating a range of integrated applications, including infrared laser energy transmission (space-to-earth and space-to-space), on-orbit high-performance computing clusters (GPU/TPU), and secure, high-bandwidth optical data transport.Traditional energy and data systems are hampered by outdated infrastructure and complex logistics. Aetherflux addresses these issues by enabling direct, on-demand, secure, and scalable energy distribution and data processing from space. This transformative approach will redefine operations both in orbit and on Earth, supporting the burgeoning space industrial base, ISAM (In-Space Servicing, Assembly, and Manufacturing) operations, and mission-critical environments.Founded in 2024 by Baiju Bhatt, inspired by his father's work with NASA Langley Research Center, Baiju holds a B.S. in Physics and an M.S. in Mathematics from Stanford. He previously co-founded Robinhood, which has empowered over 20 million Americans to access the financial system.With $90 million raised from esteemed investors including Index Ventures, Interlagos, Construct Ventures, Breakthrough Energy Ventures, Andreessen Horowitz, and NEA, we are on an ambitious path that requires exceptional talent. Our team comprises professionals with backgrounds from SpaceX, Astranis, NASA, Anduril, and the U.S. Navy, all based in San Carlos, CA. If you are ready to tackle complex technical challenges and be part of a generational energy and infrastructure company, we encourage you to apply.The RoleWe are seeking a dynamic Director of Compute Software to spearhead the architecture, development, and deployment of the software systems that drive our space-based computing platforms.In this pivotal role, you will be responsible for developing and executing the software strategy for onboard compute systems, focusing on real-time control, distributed processing, and high-bandwidth data management in orbit. Your mission will include defining and building robust, high-performance software that operates under stringent latency, power, and reliability constraints.Collaboration is key; you will work closely with hardware, spacecraft, and mission teams to ensure seamless integration between software and the underlying computing platforms. This leadership position offers significant ownership over system architecture, team development, and execution.

About Obvio AIEvery year, over 7,500 pedestrians lose their lives due to vehicular accidents in the U.S., a staggering increase of 70% over the last decade. Despite heightened awareness, numerous cities find it challenging to combat dangerous driving, resulting in inadequate 'Vision Zero' initiatives nationwide.At Obvio AI, we aim to revolutionize this landscape.We utilize solar-powered, AI-enhanced cameras to enforce traffic regulations in areas where pedestrians are most at risk—automating enforcement in ways that traditional systems and police departments cannot. Our innovative approach has already led to significant reductions in reckless driving and enhanced safety for pedestrians, drivers, and law enforcement.Founded by the creators of Motive’s AI dashcam, Obvio is supported by Bain Capital Ventures and Khosla Ventures. With a recent $22M Series A funding round, we are collaborating with some of the most progressive cities across the nation. Backed by meaningful revenue, a vast market, and strong policy support, we are building the intelligence layer for safer streets on a global scale.About the RoleAs the Head of Annotation Operations, you will oversee our annotation and review function from inception to execution as we expand our capabilities.This position will lead a team poised for substantial growth over the upcoming year. You will be responsible for designing and managing workflows, quality assurance systems, training programs, and performance evaluations essential for operating a high-throughput, safety- and compliance-critical operation.Your ResponsibilitiesAnnotation Operations & Workflow Management:Lead the implementation and ongoing enhancement of Obvio's annotation and review workflows for automated traffic enforcement.Translate enforcement requirements and edge cases into comprehensive review guidelines, task specifications, and escalation pathways.Ensure a balance between throughput, accuracy, and consistency in a high-pressure operational context.Organizational Scaling:Develop the operational framework for a rapidly growing review team, encompassing team structure, leadership roles, and quality assurance functions.Oversee recruitment, onboarding, and training programs to accelerate reviewer proficiency.Establish and manage performance assessment systems, including coaching, feedback, and accountability metrics.

Join Natera as an Associate/Assistant Laboratory Director specializing in Organ Health. In this pivotal role, you will be responsible for overseeing laboratory operations, ensuring compliance with regulatory standards, and driving innovation in organ health diagnostics. As part of our dynamic team, you will collaborate with experts across various disciplines to enhance our laboratory processes and improve patient outcomes. Your contributions will directly impact our mission to advance genetic testing for organ health.

Join Our Mission to Safeguard Humanity!At Vaxcyte, we are pioneering innovative vaccine solutions designed to protect humanity from the severe and costly impacts of bacterial diseases. Our commitment extends to addressing critical infections such as invasive pneumococcal disease, Group A Strep, and Shigella. With a clear and defined pathway ahead, Vaxcyte is poised for success in the fight against bacterial infections. Our Approach: We Value Both What We Do and How We Do It! Our collaborative efforts are driven by four core values: *RETHINK CONVENTION: We inject creativity and diverse intellect into every aspect of our work, continually innovating the vaccine delivery process. *AIM HIGH: We embrace ambitious goals, boldly tackling the complexities of biologics to safeguard human health. *LEAD WITH HEART: Vaxcyte fosters a culture of kindness and inclusivity, encouraging robust discussions that propel our objectives. *MODEL EXCELLENCE: Our challenges require a unified commitment to integrity, accountability, and clear communication.Position Overview:The Director of Device Development and Commercialization will oversee the VAX-31 drug product, an intricate biological entity consisting of 31 Drug Substances formulated as an adjuvanted suspension Drug Product. The role demands meticulous attention to the development of a pre-filled syringe (PFS) combination product for both clinical and commercial applications. We seek an enthusiastic and skilled professional to lead our Drug Product Development Team through essential development and regulatory milestones, ensuring our product's successful launch and distribution.The VAX-31DP presents unique challenges in production, handling, and testing due to its suspension system. The director will navigate these complexities by managing their team and collaborating within a matrix structure across the broader Drug Product and commercial organization. Furthermore, it is essential to comprehend, manage, and effectively communicate these challenges to regulatory bodies through compelling submissions. Experience in the vaccine sector, particularly with adjuvants, is highly desirable.

Vaxcyte, based in San Carlos, California, is a clinical-stage vaccine company working to advance vaccines that address serious bacterial diseases such as invasive pneumococcal disease, Group A Strep, and Shigella. The team values creative thinking, ambitious goals, kindness, and integrity as it pursues new solutions in vaccine development. Role overview The Associate Director, Regulatory CMC, plays a key role in both strategy and execution. This position develops and implements global regulatory CMC strategies for investigational products. The role involves leading the preparation and submission of regulatory CMC documents, managing communications with health authorities, and guiding cross-functional teams on regulatory CMC matters. Main responsibilities Develop and execute global regulatory CMC strategies for investigational products. Lead the preparation and submission of regulatory CMC documents. Manage communications with health authorities regarding CMC topics. Provide regulatory CMC guidance to cross-functional project teams. Ensure compliance with global regulatory requirements. Conduct ongoing regulatory surveillance to keep the team informed of changes in regulations.