Senior Scientist in In Vitro Diagnostic Product Development

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.

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.

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.

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.

Join Natera as a Clinical Lab Scientist II, where you will play a pivotal role in our laboratory operations, contributing to groundbreaking genetic testing technologies. You will be responsible for performing complex laboratory tests, ensuring accuracy and compliance with all regulatory requirements. Your expertise will help us deliver critical insights and improve patient outcomes.

Join Our Mission to Protect Humanity!Vaxcyte is a pioneering clinical-stage vaccine development company dedicated to engineering high-fidelity vaccines aimed at safeguarding humanity from the dire impacts of bacterial diseases. Our goal is to eradicate or effectively manage bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella. With a clear and well-defined path to success, Vaxcyte is positioned to achieve remarkable advancements in public health. Our Approach: What we do is just as important as how we do it! Our collaborative efforts are driven by four enduring core values: *RETHINK CONVENTION: We embrace creative and intellectual diversity in our work, innovating and re-innovating the delivery of vaccines. *AIM HIGH: We embody our audacious goal of courageously developing the most complex biologics ever created to protect humanity. *LEAD WITH HEART: Every team member at Vaxcyte leads with a kindness-first, inclusive approach, fostering collaboration and robust discussion that propels our business forward. *MODEL EXCELLENCE: The scale of our challenge necessitates a shared commitment to integrity, accountability, equality, and clarity in communication and decision-making.Position Summary:Vaxcyte is currently seeking a Senior Associate Scientist (Contract) specializing in Conjugation Development. This role will support the development of a robust process for generating our proprietary pneumococcal conjugate vaccine. Responsibilities include reviewing analytical data and electronic notebook entries for accuracy and compliance with standard operating procedures (SOPs). This is a remote, part-time position offering flexible working hours, requiring exceptional organizational skills, clear communication, and meticulous attention to detail.

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 a pioneering clinical-stage vaccine development company dedicated to creating high-fidelity vaccines aimed at safeguarding humanity from the dire consequences of bacterial diseases. Our mission is not just to combat but to eradicate or effectively treat serious bacterial infections including invasive pneumococcal disease, Group A Strep, and Shigella. We have a clear, structured path to success, and Vaxcyte is prepared to lead the charge. Our Approach: Our work is defined by our commitment to four core values: *Challenge the Norm: We infuse creativity and diverse perspectives into all aspects of our endeavors to revolutionize vaccine delivery. *Aim High: We strive to achieve our ambitious goal of developing the most complex biologics ever created to protect humanity. *Lead with Empathy: Every team member at Vaxcyte fosters a collaborative environment that prioritizes kindness and constructive debate, propelling our objectives forward. *Exemplify Excellence: The challenges we face demand a collective commitment to integrity, accountability, and transparent communication.Position Overview:We are on the lookout for a highly motivated and detail-oriented Senior Associate Scientist (Contract) to join our Polysaccharide Analytical Development team. The primary focus of this role is to support the analytical testing and characterization of polysaccharide-based drug candidates. The successful candidate will execute and refine various biochemical and chromatographic assays, contribute to method development initiatives, and ensure the generation of high-quality data in alignment with our research and development programs.This position demands robust hands-on experience with HPLC-based techniques, biochemical assays, and analytical software platforms, alongside a steadfast commitment to data integrity, meticulous documentation, and collaborative efforts across functions.

Join Our Mission to Safeguard Humanity!At Vaxcyte, we are pioneering vaccine innovation to safeguard humankind against the severe health impacts of bacterial diseases. Our efforts aim to eradicate or treat infections such as invasive pneumococcal disease, Group A Strep, and Shigella. With a clear and structured path to success, Vaxcyte is poised to make a profound impact in the realm of healthcare. Our Approach: We believe that the manner in which we achieve our goals is as critical as the goals themselves. Our collaborative efforts are anchored by four foundational values: *Rethink Convention: We embrace creativity and diverse perspectives to innovate and continuously improve vaccine delivery methods. *Aim High: We strive to achieve audacious goals, tackling the most complex biologics to protect humanity. *Lead with Heart: Leadership at Vaxcyte is characterized by kindness, inclusivity, and constructive debate to further our business objectives. *Model Excellence: We are committed to integrity, accountability, and clarity in all communications and decision-making processes.Position Summary:The Development organization consists of four specialized Process teams: Protein, Polysaccharide, Conjugate Drug Substance (Conjugation), and Drug Product, supported by Analytical Development and Formulation Development teams. Vaxcyte is seeking a Senior Associate Scientist (contract) with expertise in microbial fermentation and upstream processing to join our Upstream Polysaccharide Process Development team. The successful candidate will lead experimental design and execution to enhance and optimize polysaccharide manufacturing processes involving microorganisms. A hands-on laboratory background in microbial fermentation is essential, along with a keen willingness to acquire new laboratory skills. This role mandates over 50% of time spent in the lab, requiring the ability to independently document experimental procedures and results in both written and presentation formats. Additionally, the candidate will work closely with cross-functional teams, drafting technical reports and presenting experimental findings.

Natera, Inc. is hiring a Scientist in Product Development to join the team in San Carlos, CA. This role centers on advancing genetic testing solutions and contributing to the company’s research and development efforts. Key responsibilities Design experiments that support the creation of new genetics products Analyze experimental results and interpret data to inform next steps Develop and refine methodologies to enhance Natera’s product offerings Collaborate with colleagues from different teams to drive research projects forward What makes this role unique This position provides a direct path to influence the future of genetics research and product development. Success depends on strong scientific knowledge and the ability to think critically about complex problems.

Role Overview Natera is hiring a Senior Manager of Research and Development for the Oncology Product Development team in San Carlos, CA. This leader will guide the development and optimization of next-generation sequencing (NGS)-based oncology diagnostic assays. The position also supports ongoing product lifecycle management after launch. Success in this role depends on strong technical leadership, cross-functional collaboration, and a focus on product performance and scalability. What You Will Do Direct the technical development of NGS-based oncology assays, including project planning, execution, and coordination across teams. Drive assay development from feasibility through verification and validation in a regulated CLIA setting. Work closely with Research, Informatics, Statistics, Software, Regulatory, Quality, and Commercial groups to move products from concept to launch. Support post-launch efforts such as process improvements, troubleshooting, and working with Operations on commercialized assays. Prepare and review technical documents, including study protocols, reports, and validation materials, ensuring regulatory and product requirements are met. Mentor and manage team members, supporting their professional growth. Lead and oversee data analysis using statistical methods. Qualifications PhD in Molecular Biology or 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 environment (CLIA experience preferred). Familiarity with CLIA laboratory workflows and assay implementation in production. History 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 Deep technical knowledge of oncology diagnostics and NGS technologies. Strong analytical thinking and problem-solving skills. Skilled in technical writing and documentation for regulated environments. Understanding of regulatory standards and design control processes (such as LDT, CAP/CLIA, product development lifecycle, and change management). Excellent collaboration, communication, and interpersonal abilities.

About Vaxcyte Vaxcyte is a clinical-stage vaccine company based in San Carlos, California. The team focuses on developing vaccines that help prevent serious bacterial diseases, including invasive pneumococcal disease, Group A Strep, and Shigella. The company’s mission centers on advancing vaccine science to protect communities worldwide. Our Values Rethink Convention: Encouraging new ideas and diverse viewpoints to improve vaccine delivery. Aim High: Pursuing major advancements in biologics to promote better health outcomes. Lead with Heart: Practicing kindness, inclusivity, and open communication in leadership and teamwork. Model Excellence: Upholding integrity, accountability, equality, and clear communication in every challenge. Role Overview: Senior Manager of Indirect Procurement for Clinical Development The Senior Manager of Indirect Procurement for Clinical Development will lead procurement activities that support clinical development programs at Vaxcyte. This position acts as a strategic partner to the Clinical Operations Department and works closely with Finance and Legal teams. The role covers the full procurement process for clinical trials, from project start to closeout, and adapts to changing indirect spend categories across the company. Key Responsibilities Manage procurement support for clinical development initiatives. Oversee the requisition to purchase order process for clinical trials. Support vendor selection and coordinate contracts to ensure timely, compliant, and cost-effective engagements. Collaborate with Clinical Operations, Finance, and Legal teams throughout the procurement lifecycle.

Join Our Mission to Safeguard Humanity!Vaxcyte is a pioneering clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines that shield humanity from the severe and costly health impacts of bacterial diseases. Our mission focuses on eradicating or treating bacterial infections, including invasive pneumococcal disease, Group A Strep, and Shigella, marking just the beginning of our journey. With a clear and well-defined path to success, Vaxcyte is poised to make a lasting impact. Our Approach is as vital as Our Mission! Our collaborative efforts are anchored in four enduring core values: *RETHINK CONVENTION: We infuse creativity and intellectual diversity into every aspect of our work, continuously innovating how vaccines are delivered. *AIM HIGH: We embrace our ambitious goal to courageously tackle the most complex biologics aimed at protecting humanity. *LEAD WITH HEART: At Vaxcyte, everyone plays a leadership role with a kindness-first, inclusive approach that fosters collaboration and constructive debate to advance our business objectives. *MODEL EXCELLENCE: The magnitude of our challenge demands a shared commitment to integrity, accountability, equality, and clarity in communications and decision-making.Position Summary:Vaxcyte offers an exciting opportunity for a proactive and skilled individual to join our Analytical Development team as a Scientist II. In this role, you will execute analytical testing and contribute to the development of analytical methods for biologics and vaccine programs. You will perform both routine and complex analytical assays utilizing cutting-edge techniques, support method optimization and troubleshooting efforts, and engage in continuous improvement initiatives with moderate supervision while collaborating effectively with cross-functional teams. This position requires hands-on laboratory experience, strong technical execution, and problem-solving abilities, along with the capability to independently plan and execute assigned tasks, analyze and interpret data, and initiate or drive investigations as necessary. You will also author and maintain clear technical documentation, including method protocols, development summaries, and SOPs, while communicating experimental results and conclusions to internal stakeholders.

Be Part of 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 severe and costly repercussions of bacterial diseases. Our mission goes beyond just addressing invasive pneumococcal disease, Group A Strep, and Shigella; we are committed to eradicating or treating bacterial infections through innovative solutions. With a clear and defined pathway to success, Vaxcyte is poised to make a significant impact in the field of vaccines. Our Work Ethos: What we achieve is equally matched by how we achieve it. Our collaborative efforts are underpinned by four enduring core values: *Rethink Convention: We embrace creative and intellectual diversity to innovate and continuously enhance vaccine delivery methods. *Aim High: We collectively strive to accomplish our ambitious goal of developing the most complex biologics to protect humankind. *Lead with Heart: At Vaxcyte, every individual leads with a kindness-first approach, fostering inclusive collaboration and constructive debate that propels our business objectives forward. *Model Excellence: Given the magnitude of our challenges, we commit to demonstrating integrity, accountability, equality, and clarity in our communications and decision-making processes.Position Summary:We are currently seeking a Scientist II in Conjugation Development. The selected candidate will primarily lead and execute experimental activities supporting our pneumococcal conjugate vaccine program, focusing on enhancing the understanding of the conjugation process. Concurrently, this role involves developing the conjugation process for Vaxcyte’s pipeline programs, contributing to process optimization, scalability, and readiness for future clinical manufacturing. Key responsibilities include the preparation, purification, and analytical characterization of chemically modified polysaccharides and polysaccharide-protein conjugates. The ideal candidate will have substantial laboratory experience and a robust understanding of analytical chemistry principles, with the ability to design, execute, and troubleshoot experiments independently. Additionally, contributions to analytical development and stability studies may be required. Responsibilities will also encompass record management and data presentation to the team.

Natera is hiring a Research Scientist to join the R&D team in San Carlos, CA. This role centers on developing new technologies and methods that support patient care. Key responsibilities Design and execute experiments aligned with research objectives Analyze data from experiments and interpret findings Collaborate with colleagues across various disciplines to move research projects forward Role overview This position offers the chance to contribute to technology and method development within a collaborative research environment. The focus remains on work that can positively impact patient care through scientific innovation.

Join Our Mission to Protect Humanity!At Vaxcyte, we are a pioneering clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines aimed at safeguarding humanity from the dire consequences of bacterial diseases. Our goal is to combat serious bacterial infections, including invasive pneumococcal disease, Group A Strep, and Shigella. We are on a clear pathway to success, determined to make a significant impact in the world of vaccine development. Our Approach: We believe that what we do is as important as how we do it. Our collaborative work is anchored by four core values: *RETHINK CONVENTION: We embrace creative and intellectual diversity in all aspects of our work to innovate and transform vaccine delivery. *AIM HIGH: We strive to achieve audacious goals, courageously tackling the most complex biologics to protect humankind. *LEAD WITH HEART: At Vaxcyte, leadership is about kindness and inclusivity, fostering collaboration and robust discussions that further our mission. *MODEL EXCELLENCE: Our ambitious challenges necessitate a shared commitment to integrity, accountability, and clarity in our communications and decision-making processes.Position Overview:We invite a dynamic and skilled individual to become part of our Analytical Development team as a Scientist I. In this role, you will execute analytical testing and play a vital role in the development of analytical methods for our biologics and vaccine programs.This position entails performing both routine and advanced analytical assays utilizing modern techniques. You will support method optimization and troubleshooting, engage in continuous improvement initiatives with moderate supervision, and work effectively within cross-functional teams. The ideal candidate will possess hands-on laboratory experience, exceptional technical execution, and robust problem-solving abilities. You will independently plan and execute tasks, analyze and interpret data, and drive or escalate investigations as necessary. Additionally, you will author and maintain comprehensive technical documentation, including method protocols, development summaries, and SOPs, while effectively communicating experimental results to internal stakeholders.

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.

About Vaxcyte Vaxcyte, Inc. is advancing vaccine research in San Carlos, California, with a focus on high-fidelity vaccines targeting serious bacterial diseases. The team works to address infections such as invasive pneumococcal disease, Group A Streptococcus, and Shigella. Vaxcyte’s mission centers on reducing or managing these health threats through innovative science and a clear, strategic vision. Our Values Rethink Convention: Encourage creativity and welcome diverse perspectives to improve vaccine delivery. Aim High: Pursue ambitious goals in developing complex biologics for public health. Lead with Heart: Foster a collaborative culture rooted in kindness, inclusivity, and healthy debate. Model Excellence: Commit to integrity, accountability, and clear communication in all work. Role Overview: Associate Scientist II, Vaccine Research The Research team relies on a broad set of chromatographic techniques to purify vaccine antigens. This role calls for hands-on experience with multiple chromatography methods, including monoclonal antibody/Protein A workflows. Candidates should have worked on selecting, screening, developing, scaling up, and characterizing various chromatography techniques. Main Responsibilities Carry out AKTA FPLC chromatography, including: Immobilized metal affinity chromatography (IMAC) Ion-exchange chromatography (IEX) Hydrophobic interaction chromatography (HIC) Size-exclusion chromatography (SEC) Hydroxyapatite (CHT / HA) Design chromatography trains to reduce host cell proteins, endotoxins, and aggregates by combining complementary techniques. Apply Design of Experiments (DoE) for multimodal optimization (experience in this area is a plus). Use membrane chromatography for high-throughput contaminant analysis.