Senior Manager, Quality Control, Reference Standards
2 days ago
Vaxcyte is a clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines to safeguard humankind from the consequences of bacterial diseases. Our mission is to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella.
Our Core ValuesWe are guided by four enduring core values that shape our work:
- Rethink Convention: We bring creative and intellectual diversity to every facet of our work to innovate and re-innovate the way vaccines are delivered.
- Aim High: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
- Lead with Heart: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
- Model Excellence: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality, and clarity across communications and decision making.
We are seeking a Senior Manager for our Quality Control (QC) Reference Standards team to oversee the management and continuous supply of reference standards and critical reagents for testing and releasing clinical and commercial products. This role is pivotal in ensuring compliance with global regulatory guidelines and supporting our pipeline of high-fidelity vaccines.
Key Responsibilities- Reference Standards Management: Oversee the implementation and maintenance of the reference standards and critical reagent program, ensuring compliance with cGMP and ICH guidelines.
- Program Development: Support the development of global business practices, policies, and standards for reference standards and critical reagents, including qualification, requalification, and inventory management.
- Documentation and Compliance: Collaborate in the authoring and review of technical protocols, qualification reports, requalification reports, and Certificates of Analysis (CoAs) related to reference standards. Ensure timely updates to SOPs and other relevant documentation.
- Inventory Management: Manage supply chain logistics, including inventory and space planning, to ensure a continuous supply of qualified reference standards and critical reagents.
- Collaboration and Communication: Serve as a key point of contact within Vaxcyte QC and with external partners, fostering productive collaborations to support the company's vaccine programs.
- Technical Expertise: Provide technical guidance on assay qualification and validation to meet regulatory standards, and review test methods and release documentation for reference standards.
- Quality Oversight: Review and manage deviations, OOS/OOT results, and conduct risk assessments related to reference standards and critical reagents.
- Bachelor's, Master's, or Ph.D. in Biochemistry, Chemistry, or a related field. Ph.D. with 5+ years of relevant QC experience, or MS/BS with 8+ years of experience, including significant experience in reference standard management.
- Strong background in cGMP and ICH regulatory guidance associated with reference standards and critical reagents.
- Experience working with biochemistry, immunoassay, or microbiological assay techniques.
- Familiarity with statistical software (e.g., JMP) for data analysis, trending, and process optimization.
- Excellent organizational and project management skills, with the ability to handle multiple projects under tight timelines.
- Strong written and verbal communication skills, including the ability to work effectively in cross-functional teams.
- Proficiency in LIMS and other laboratory data management systems is preferred.
Associate Director, Quality Control, Reference Standards
LocationSan Carlos, CA
CompensationThe compensation package will be competitive and includes comprehensive benefits and an equity component.
The salary range is $180,000 - $187,000.
-
San Carlos, California, United States BioSpace, Inc. Full timeJob SummaryVaxcyte is seeking an experienced Associate Director to lead the quality control team in managing reference standards and critical reagents. The successful candidate will be responsible for developing and implementing policies, procedures, and strategies for global reference standard and critical reagent management systems.Key...
-
Senior Quality Control Specialist
3 weeks ago
San Carlos, California, United States The Steely Group Full time{"title": "Senior Quality Control Specialist", "content": "Job SummaryThe Steely Group is seeking a highly skilled Senior Quality Control Specialist to support the daily operations of our Quality Control group. As a key member of our team, you will be responsible for ensuring the quality and integrity of our products.Key ResponsibilitiesSupport sampling and...
-
Senior Quality Control Specialist
4 weeks ago
San Carlos, California, United States The Steely Group Full timeJob Title: Senior Quality Control SpecialistWe are seeking a highly skilled Senior Quality Control Specialist to support the daily operations of our Quality Control group. As a key member of our team, you will be responsible for ensuring the quality and integrity of our products.Responsibilities:Support sampling and testing of incoming raw materials to...
-
Senior Quality Control Specialist
3 weeks ago
San Carlos, California, United States The Steely Group Full timeJob OverviewWe are seeking a highly skilled and detail-oriented Senior Quality Control Specialist to join our Quality Control team. As a key member of our team, you will be responsible for supporting the daily operations of the Quality Control group, while contributing to the development of new processes that maximize our technology and enhance our internal...
-
San Francisco, California, United States Nurix, Inc. Full timeJob Title: Manager/Senior Manager, Analytical Development and Quality ControlNurix Therapeutics is a biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative small molecule therapies for cancer and immune disorders.We are seeking an experienced Manager/Senior Manager to join our Analytical Development and Quality...
-
San Francisco, California, United States Nurix, Inc. Full timeJob Title: Manager/Senior Manager, Analytical Development and Quality ControlNurix Therapeutics is a biopharmaceutical company dedicated to developing innovative treatments for cancer and immune disorders. We are seeking an experienced Manager/Senior Manager to join our Analytical Development and Quality Control team.About the RoleThe Manager/Senior Manager...
-
Quality Control Manager
2 days ago
San Carlos, California, United States Vaxcyte Full timeProtect Humankind from Bacterial DiseasesVaxcyte is a clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines to safeguard humankind from the consequences of bacterial diseases. Our mission is to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella. We are...
-
Senior Manager, Quality Assurance
6 days ago
San Carlos, California, United States Sutro Biopharma Full timeJob Title: Senior Manager, Quality AssuranceSutro Biopharma, Inc. is seeking a highly experienced Senior Manager, Quality Assurance to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the quality and compliance of our products and processes.Key Responsibilities:Develop and implement quality assurance...
-
Senior Quality Control Specialist
2 weeks ago
San Carlos, California, United States The Steely Group Full timeSr. QC Analyst Job DescriptionWe are seeking a highly skilled and experienced Sr. QC Analyst to join our Quality Control team at The Steely Group. As a key member of our team, you will play a critical role in ensuring the quality and integrity of our products.Key Responsibilities:Support sampling and testing of incoming raw materials to ensure compliance...
-
San Francisco, California, United States Nurix, Inc. Full timeJob Title: Senior Manager/Associate Director, Analytical Development and Quality ControlNurix Therapeutics is a biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative small molecule therapies for cancer and immune disorders.We are seeking an experienced Senior Manager/Associate Director to join our CMC...
-
San Diego, California, United States Danaher Corporation Full timeQuality Assurance and Quality Control Senior ManagerAt Danaher Corporation, we are committed to accelerating the real-life impact of tomorrow's science and technology. As a Quality Assurance and Quality Control Senior Manager, you will play a critical role in driving quality and production excellence in our Carlsbad, CA, USA location.Key...
-
San Francisco, California, United States Nurix, Inc. Full timeJob Title: Manager/Senior Manager, Analytical Development and Quality ControlNurix Therapeutics is a biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative small molecule therapies for cancer and immune disorders. Our team is seeking an experienced Manager/Senior Manager to join the Analytical Development and...
-
Senior Quality Manager
3 weeks ago
San Diego, California, United States Ignite Human Capital Full timeJob Title: Senior Quality ManagerWe are seeking a highly experienced Senior Quality Manager to join our team at Ignite Human Capital. This role will be responsible for developing, implementing, and maintaining a robust quality system to ensure compliance with internal and external standards.Key Responsibilities:Develop and implement quality assurance and...
-
Senior Quality Manager
3 days ago
San Diego, California, United States Ignite Human Capital Full timeAbout Us:Ignite Human Capital is a leading provider of innovative solutions for businesses. We pride ourselves on delivering high-quality products and services to our clients. We are looking for a talented Senior Quality Manager to join our team.Job Summary:The senior quality manager will be critical to the supply chain leadership team and will be...
-
San Francisco, California, United States BioSpace, Inc. Full timeJob DetailsCompany OverviewNurix Therapeutics is a biopharmaceutical company dedicated to developing innovative small molecule therapies for cancer and immune disorders. Leveraging its expertise in E3 ligases and proprietary DNA-encoded libraries, Nurix has created DELigase, a comprehensive discovery platform to identify and advance novel drug candidates...
-
Quality Control Specialist
3 days ago
San Carlos, California, United States BioSpace, Inc. Full timeJob Title: QC ContractorSutro Biopharma, Inc. is seeking a highly skilled and experienced Quality Control Contractor to join its team in San Carlos, CA. As a key member of the Quality Control group, you will be responsible for supporting the daily operations of the laboratory, ensuring the quality and integrity of our products, and contributing to the...
-
Senior Quality Control Associate
2 days ago
San Diego, California, United States Wacker Chemie AG Full timeJob Title: Sr. QC Associate - AnalyticalAre you a seasoned analytical expert looking to take on a leadership role in a dynamic and innovative company? Do you have a passion for quality control and a desire to make a meaningful impact in the pharmaceutical industry? We are seeking a highly skilled Sr. QC Associate - Analytical to join our team at Wacker...
-
Senior Quality Manager
1 day ago
San Diego, California, United States Ignite Human Capital Full timeAbout UsIgnite Human Capital is a leading provider of high-quality products and services. We pride ourselves on innovation, sustainability, and excellence, and we are looking for a talented Senior Quality Manager to join our team.Job SummaryThe Senior Quality Manager will be critical to the supply chain leadership team and will be responsible for developing,...
-
Senior Quality Assurance Specialist
1 day ago
San Carlos, California, United States BioSpace, Inc. Full timeJob SummaryThe Senior Quality Assurance Specialist - Supplier Quality will play a pivotal role in ensuring that all external suppliers and third-party vendors adhere to Vaxcyte's quality standards and regulatory requirements. This individual will manage supplier audits, evaluate supplier performance, and support the development of quality agreements,...
-
Senior Quality Manager
1 day ago
San Diego, California, United States Ignite Human Capital Full timeJob Title: Senior Quality ManagerIgnite Human Capital is seeking a highly experienced Senior Quality Manager to lead our Food Safety and Quality Control team. This role will be responsible for developing, implementing, and maintaining a robust quality system to ensure compliance with internal and external standards.Key Responsibilities:Develop and implement...
