Executive Director of Clinical Regulatory Affairs

Vaxcyte, based in San Carlos, California, develops vaccines aimed at preventing serious bacterial diseases such as invasive pneumococcal disease, Group A Strep, and Shigella. The company’s mission is to advance vaccine science and help protect communities around the world. The team values fresh thinking, high standards, and open communication. Vaxcyte encourages new ideas to improve vaccine delivery, strives for significant progress in biologics, and emphasizes kindness, inclusivity, and clear communication. Integrity and accountability guide their approach to every challenge. Role overview The Senior Manager of Indirect Procurement for Clinical Development leads procurement efforts that support clinical development programs. This role serves as a strategic partner to Clinical Operations and works closely with Finance and Legal. Responsibilities span the entire procurement process for clinical trials, from project initiation through closeout, and require flexibility as indirect spend categories evolve. Key responsibilities Direct procurement support for clinical development initiatives Oversee the requisition to purchase order process for clinical trials Assist with vendor selection and coordinate contracts to ensure engagements are timely, compliant, and cost-effective Work with Clinical Operations, Finance, and Legal teams throughout the procurement lifecycle

Senior Indirect Sourcing SpecialistLocation: San Carlos, CAAbout 1XAt 1X, we are pioneering the future of work by developing humanoid robots that collaborate with humans to address labor shortages and drive productivity.Role OverviewWe are in search of a Senior Indirect Sourcing Specialist to spearhead sourcing initiatives and oversee category management related to infrastructure and indirect expenditures at 1X. This pivotal role requires close collaboration with Global Supply Managers and diverse stakeholders to implement sourcing strategies that enhance our facilities, IT infrastructure, factory operations, and corporate services. As a member of our dynamic infrastructure sourcing team, you will play a vital role in our organizational success.Commodity ownership assignments will be determined based on your experience and the current needs of the business. Prospective candidates are not required to possess experience in all specified categories.Your ResponsibilitiesImplement sourcing strategies across designated infrastructure and indirect categories.Lead RFQs, supplier assessments, negotiations, and contract management.Collaborate with Facilities, IT, Manufacturing, Operations, and Finance departments.Support infrastructure programs, site operations, and scaling efforts.Monitor supplier performance, costs, and sourcing metrics.Drive continuous improvement and cost-saving initiatives.Infrastructure & Indirect Categories Supported (one or more areas):Facilities maintenance and site services.Construction and site expansion services.CAPEX equipment and installation services.IT infrastructure and technology services.Support for factory production (tooling, MRO, consumables).Corporate services (travel, HR-related services, insurance).The scope of categories will be aligned with your experience and may evolve as the organization expands.

Join 1X as a Senior Sourcing Manager - Indirect OperationsLocation: San Carlos, CA (on-site)About 1XAt 1X, we are pioneering the development of humanoid robots that collaborate with humans to address labor shortages and foster a culture of abundance in the workforce.Role OverviewWe are looking for a dynamic Indirect Team Manager to spearhead our Infrastructure and Indirect Sourcing initiatives. This role will be pivotal in cultivating and scaling a highly effective sourcing team that will support facilities, IT infrastructure, factory operations, and corporate services as we expand. Your expertise in judgment, prioritization, and people leadership will be essential in navigating our evolving environment.Your ResponsibilitiesLead and mentor a team of Global Sourcing Managers and Sourcing Specialists.Develop and implement the indirect sourcing strategy across our global locations.Collaborate closely with Facilities, IT, Manufacturing, Real Estate, Finance, and HR to align goals.Establish priorities, manage escalations, and synchronize sourcing efforts with company growth objectives.Drive initiatives for cost optimization, supplier performance enhancement, and risk management.Formulate sourcing strategies and operating models for infrastructure and indirect expenditures.Assist in planning infrastructure for new locations, expansions, and operational scalability.Team-Based Commodity OversightIT infrastructure and network servicesFacilities maintenance and site servicesConstruction, CapEx, and site expansionFactory production support (tooling, MRO, consumables)Corporate services (travel, HR-related services)Commodity management will be distributed among team members based on their experience and business requirements.

Aetherflux develops advanced satellites to reshape the orbital economy, focusing on solar energy capture, energy transmission using infrared lasers, and high-bandwidth optical data delivery. The company, founded in 2024 by Baiju Bhatt (Robinhood co-founder), draws on expertise from leading aerospace and defense backgrounds and is backed by prominent investors. Aetherflux aims to transform how energy and data move in space and on Earth, taking on complex technical challenges to build new space infrastructure. Role overview The Senior Sourcing and Procurement Manager will drive hardware sourcing for Aetherflux’s ambitious satellite programs. This individual contributor role manages the full lifecycle of purchase orders and supplier relationships, ensuring teams receive the materials, components, and services needed to meet rapid development goals. The position suits someone who thrives in a high-growth environment and combines analytical rigor with practical supply chain execution. Advancement to supervisory or managerial roles is possible as the company grows. What you will do Oversee purchase orders from initiation through completion, including supplier negotiations, risk mitigation, and vendor management for key projects. Develop and maintain sourcing tools and dashboards to track supplier performance, spending, and delivery accuracy. Lead cost-saving efforts by working with suppliers and identifying opportunities for manufacturing or process improvements. Manage procurement workflows, conducting pre-award reviews to ensure quality and compliance in purchasing packages. Identify and implement automation to streamline procurement and reduce manual work. Work closely with engineering, finance, and operations teams to support hardware development and production. Requirements This role requires experience managing sourcing and procurement for engineered products, strong analytical and negotiation skills, and a hands-on approach to supply chain operations. Comfort working in a fast-moving, high-growth setting is essential.

Join Natera as a Senior Clinical Scientist in Oncology, where you will play a vital role in advancing our mission to transform the field of oncology through innovative diagnostics. You will leverage your expertise to drive clinical research projects and collaborate with cross-functional teams to support the development of cutting-edge solutions.

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.

About Q BioAt Q Bio, we are revolutionizing preventive healthcare. Collaborating with clinics and health systems, we launch cutting-edge longevity programs powered by the Q Exam—a proprietary evaluation that merges whole-body MRI with integrated biomarkers to furnish a clinically robust overview of health and early disease detection. Our mission extends beyond developing tools; we are crafting the data-driven future of personalized health.Your RoleWe are on the lookout for a Senior Technical Program Manager who will drive the successful delivery of Q Bio’s enterprise software and clinical technology initiatives. This pivotal role is responsible for overseeing complex, regulated programs, establishing a clear operational rhythm, identifying risks early, and ensuring disciplined follow-up across diverse teams. Working closely with Product, Engineering, Clinical, Quality, Security, and external stakeholders, the Senior Technical Program Manager will guarantee alignment and progress—infusing structure, visibility, and disciplined execution into multifaceted, cross-functional projects. In light of Q Bio’s evolving nature, this position will not only operate within current parameters but will also contribute to the development of systems, processes, and governance that facilitate predictable, scalable execution as the organization evolves.Key ResponsibilitiesAccountability & ProgressDefine clear ownership, milestones, and success criteria for all programs. Propel disciplined, visible progress and ensure that commitments are achieved or proactively escalated.Operational TransparencyCreate and maintain a comprehensive source of truth regarding program health, encompassing schedules, dependencies, risks, and resources. Offer leadership high-fidelity, decision-ready visibility.Interdependency ManagementProactively identify and manage cross-functional dependencies across Product, Engineering, Clinical, Regulatory, Security, and external collaborators to sustain program momentum.Engineering Force MultiplierOversee coordination, logistics, and follow-through to enhance execution efficiency, enabling engineers and scientists to concentrate on high-impact delivery and innovation.

Join Our Mission to Safeguard Humanity!Vaxcyte is a pioneering clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines aimed at protecting humanity from the dire consequences of bacterial diseases. Our mission to combat and eradicate bacterial infections—including invasive pneumococcal disease, Group A Strep, and Shigella—is just the beginning. With a clear and defined path to success, Vaxcyte is positioned to make a lasting impact. Our Approach: At Vaxcyte, what we do is as crucial as how we achieve it. Our work is guided by four core values: *RETHINK CONVENTION: We leverage creative and intellectual diversity to innovate and redefine the delivery of vaccines. *AIM HIGH: We pursue our ambitious goal of developing the most complex biologics ever attempted for the protection of humanity. *LEAD WITH HEART: At Vaxcyte, we prioritize kindness and inclusivity in our collaborative efforts, fostering vigorous discussions that align with our business objectives. *MODEL EXCELLENCE: Our shared challenge necessitates a commitment to integrity, accountability, equality, and clarity in all communications and decisions.Summary:Vaxcyte is seeking a dynamic and skilled individual to join our Vaccine Product Development team as a Stability Manager within the Quality Control Unit. This role is vital for managing the stability program for various projects in preclinical and clinical development.In this position, you will play an essential role in implementing and upholding cGMP Stability for all stages of clinical development. Your primary responsibilities will include overseeing stability studies for individual projects and analyzing stability data. You will collaborate closely with QC team members in a highly cooperative and cross-functional environment. The ideal candidate will bring extensive stability experience, ensure compliant operations and documentation, promote open communication, and adopt data-driven methodologies.

Role overview Natera seeks a Senior Manager of Research and Development to join the Oncology Product Development team in San Carlos, CA. This leader will oversee the development and optimization of next-generation sequencing (NGS)-based oncology diagnostic assays. The role also includes supporting product lifecycle management after launch. Success depends on technical leadership, strong collaboration across teams, and attention to product performance and scalability. What you will do Direct the technical development of NGS-based oncology assays, including project planning, execution, and coordination with multiple teams. Lead assay development from feasibility through verification and validation within a regulated CLIA environment. Work in partnership with Research, Informatics, Statistics, Software, Regulatory, Quality, and Commercial teams to bring products from concept to launch. Support post-launch activities such as process improvements, troubleshooting, and collaboration with Operations on commercialized assays. Prepare and review technical documents, including study protocols, reports, and validation materials to meet regulatory and product requirements. Mentor and manage team members, fostering their professional growth. Lead and oversee data analysis using statistical methods. Requirements PhD in Molecular Biology or a related field with at least 6 years of relevant industry experience, or BS/MS with a minimum of 8 years in biotech, including at least 2 years in management. Hands-on experience developing NGS-based assays in a regulated setting; CLIA experience preferred. Familiarity with CLIA laboratory workflows and implementing assays in production. Track record of leading projects and collaborating across functions; people management experience is a plus. Experience with high-throughput workflows or automation is beneficial. Knowledge and skills Strong technical background in oncology diagnostics and NGS technologies. Analytical thinking and problem-solving abilities. Proficiency in technical writing and documentation for regulated environments. Understanding of regulatory standards and design control processes, including LDT, CAP/CLIA, product development lifecycle, and change management. Excellent collaboration, communication, and interpersonal skills.

Join Natera as a Clinical Lab Supervisor, where you'll lead a team of professionals in a dynamic clinical laboratory environment. In this pivotal role, you will oversee daily laboratory operations, ensuring compliance with quality standards and regulatory requirements. Your leadership will foster a culture of excellence and innovation as you mentor and develop staff, driving continuous improvement in laboratory processes.

Join Natera as a Clinical Lab Supervisor, where you will lead and manage laboratory operations while ensuring compliance with standards and regulations. This pivotal role involves supervising laboratory staff, maintaining quality control, and collaborating with cross-functional teams to enhance lab efficiency.

Join Natera as a Lead Clinical Lab Scientist, where you will play a pivotal role in advancing our laboratory operations. We are seeking an experienced and passionate scientist who is ready to lead a team, drive innovation, and ensure the highest quality standards in our clinical laboratory environment.In this role, you will oversee laboratory procedures, mentor junior staff, and collaborate with cross-functional teams to optimize lab performance. Your expertise will be crucial in implementing new technologies and methodologies that enhance our testing capabilities and improve patient outcomes.

Role Overview The Lead Clinical Laboratory Scientist at Natera, Inc. in San Carlos, CA, plays a key part in specimen analysis and daily lab operations. This position works closely with the supervisor to meet production goals and maintain high standards in laboratory practices. Main Responsibilities Verify specimen accuracy for patient testing and perform required laboratory tests with precision. Support daily laboratory operations by following standard operating procedures and minimizing errors. Maintain Good Laboratory Practices (GLP), reporting any deviations from protocols to management. Complete production tasks on schedule and process all case samples efficiently. Assist the supervisor with projects assigned by management. Serve as the main point of contact on the lab floor when the supervisor is absent. Train new team members in current laboratory procedures and help implement new processes. Support staff competency evaluations alongside the supervisor and laboratory trainer. Deliver specialized training on laboratory instruments and protocols. Troubleshoot and resolve equipment malfunctions and laboratory errors. Understand the full laboratory workflow and address operational issues as they arise. Ensure correct rollout of new laboratory procedures. Communicate laboratory issues and team concerns to supervisors or managers, offering solutions where possible. Report discrepancies in team performance to the supervisor. Provide constructive feedback during team performance evaluations. Participate in regular meetings with the supervisor. Promote professionalism and maintain team morale, serving as a role model for colleagues. Follow all departmental expectations. Handle Protected Health Information (PHI) in both paper and electronic formats, using various technologies as required. Complete all required HIPAA/PHI privacy, policy, and security training within the first 30 days of employment. Stay current with Natera training requirements. Perform other duties as assigned.

We are seeking a highly skilled Senior Scientist to join our Research and Development team at Natera in San Carlos, California. In this pivotal role, you will lead innovative projects that contribute to groundbreaking advancements in genetic testing and diagnostics. You will collaborate with cross-functional teams, driving research initiatives that enhance our product offerings and improve patient outcomes.

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.

Join Natera as a Lead Biostatistician in Clinical Research, where you will play a pivotal role in the design and analysis of clinical trials. You will collaborate closely with cross-functional teams and contribute to the advancement of innovative healthcare solutions. This is an exciting opportunity to lead statistical programming efforts, ensuring the highest standards of quality and compliance in clinical data analysis.

Join Our Mission to Safeguard Humanity!Vaxcyte is at the forefront of vaccine innovation, dedicated to developing high-fidelity vaccines that protect against bacterial diseases, which can have severe health implications if left untreated. Our mission to combat bacterial infections like invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning of our journey. With a clear strategy for success, Vaxcyte is well-equipped to achieve meaningful outcomes. Our Approach: The way we work is as important as our mission! We are guided by four core values: *RETHINK CONVENTION: We embrace creative and diverse perspectives in our pursuit of innovative vaccine delivery methods. *AIM HIGH: We strive to achieve groundbreaking goals in the development of complex biologics that protect humanity. *LEAD WITH HEART: Collaboration and constructive debate are at the heart of our inclusive workplace, driving our business objectives forward. *MODEL EXCELLENCE: Our commitment to integrity, accountability, and clarity in communication is vital as we tackle significant challenges.Position Overview:As Vaxcyte embarks on a transformative journey to implement SAP S/4HANA in support of our rapid growth and transition to Commercial Operations, the IT SAP Supply Chain Senior Business Systems Analyst (BSA) will serve as a vital link between the Supply Chain and IT departments. This role is crucial for the successful implementation, stabilization, and continual optimization of the SAP S/4HANA Supply Chain functionalities. Candidates should possess substantial expertise in SAP Supply Chain processes, a robust understanding of contract manufacturing, and experience managing complex ERP implementation projects.Key Responsibilities:Facilitate the implementation and stabilization of SAP S/4HANA Supply Chain modules within a regulated environment.Collaborate with Supply Chain, Manufacturing, Quality, and IT teams to design future-state processes that align with Vaxcyte's CDMO business model.Assist in data mapping, migration, cleansing, and validation during cutover and post-go-live activities.Demonstrate in-depth knowledge of SAP S/4HANA systems and integration capabilities.

Join Our Mission to Safeguard Humanity!Vaxcyte is a pioneering clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines aimed at protecting humankind from the dire consequences of bacterial diseases, which can lead to severe and costly health issues if not addressed. Our efforts to combat and potentially eliminate bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella are just the beginning of our journey towards success. Vaxcyte is strategically positioned to achieve its goals. Our Work Philosophy: We believe that what we do is as crucial as how we go about it! Our collaborative efforts are guided by four foundational core values: *RETHINK CONVENTION: We embrace intellectual diversity and creativity at every level to innovate and continuously improve vaccine delivery methods. *AIM HIGH: We strive to achieve our ambitious goal of creating the most complex biologics ever developed to protect humanity. *LEAD WITH HEART: Every team member at Vaxcyte approaches leadership with kindness and inclusivity, fostering collaboration and constructive debate to meet our business objectives. *MODEL EXCELLENCE: The scale of our mission demands a unified commitment to integrity, accountability, equality, and clear communication in all our decisions. Position Overview:Vaxcyte is seeking an enthusiastic and skilled Senior Engineer to join our Polysaccharide Development and Manufacturing team within the CMC group. The successful candidate will play a pivotal role in developing a multi-valent polysaccharide-based conjugate vaccine, utilizing a novel carrier protein produced via the Xpress CF platform. With a strong emphasis on downstream purification for early-stage development and late-stage process characterization, the ideal candidate should possess significant experience in these areas. Familiarity with Design of Experiments (DOE) methodologies and proficiency in statistical software (e.g., JMP) are essential. Proven leadership in project initiatives and team management is required. The candidate must be eager to acquire new lab skills, as they will collaborate on experimental designs and execute experiments to advance our polysaccharide development and manufacturing initiatives. This role entails over 50% laboratory time, and the candidate should be capable of working independently and in collaboration with cross-functional teams.

Natera, Inc. is hiring a Clinical Lab Scientist I based in San Carlos, CA. This role plays a key part in supporting essential diagnostics by carrying out laboratory tests that directly inform patient care and clinical decisions. What you will do Perform laboratory tests following established protocols Help deliver accurate and timely diagnostic results Uphold quality standards throughout all testing procedures Role impact The work done in this position ensures that patients and clinicians have reliable information for making important healthcare decisions.