Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Skills: Sample management, Inventory management, GMP, GLP, Good Documentation Practices
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Associate Director of Data and Knowledge Management
San Carlos, California, United States · Remote OK
$183k–$214k/yr
Senior+$4.5B raised
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Skills: Supply Chain Management, ERP Transformation, SAP S/4 HANA, Business Process Design, Plan-to-Deliver
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Skills: Process Validation, Risk Management, PPQ, CPV, Biologics Manufacturing
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Sr. Director, Quality Assurance for Quality Control
San Carlos, California, United States · Remote OK
$229k–$268k/yr
Senior+$4.5B raised
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Skills: Bioprocessing, Process engineering, cGMP, FDA compliance, EMA compliance
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Skills: Digital Strategy, AI Implementation, Product Management, Commercial Operations, CRM Management
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Skills: Combination Product Development, Design Control, Pre-filled Syringes, 21 CFR Part 4, 21 CFR Part 820.3
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Skills: HPLC/UPLC, Mass Spectrometry, Capillary Electrophoresis, SDS-PAGE, ELISA
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$49/hr–$54/hr
Temporary
bachelor degree
Posted 1d ago
~40 hrs/week
Responsibilities
The Sample Management Specialist oversees the end-to-end sample management process, including receipt, storage, distribution, and inventory tracking. They ensure all activities comply with GMP/GLP regulatory standards and maintain accurate chain-of-custody documentation.
Requirements
Candidates must hold a Bachelor's degree in a life sciences discipline and possess at least 3 years of experience in a biotech or clinical laboratory setting. Proficiency in GMP/GLP principles, Good Documentation Practices, and experience with temperature-controlled storage environments are required.
Full job description
Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order 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.
Summary:
Vaxcyte is seeking a detail-oriented and motivated Sample Management Specialist to join our team. This entry- to mid-level role is responsible for overseeing and executing all aspects of the sample management process — from receipt at the warehouse through storage, distribution, and inventory management. The successful candidate will work cross-functionally with Analytical and Process Development, Materials Management, Quality Assurance, and Operations teams to ensure samples are handled, tracked, and maintained in full compliance with applicable SOPs, Good Documentation Practices, and GMP/GLP regulatory expectations.
Essential Functions:
Receive sample shipments from Shipping & Receiving following formal handoff procedures, ensuring accurate and timely transfer of custody.
Perform comprehensive sample intake activities including packing list verification, sample identification checks, sample integrity inspection, and documentation of any discrepancies or issues.
Coordinate temperature monitoring documentation and all associated shipment records to support data integrity and regulatory compliance.
Register and maintain sample records within Benchling or other approved sample tracking systems, ensuring entries are accurate, complete, and current.
Apply and maintain sample labels and associated tracking documentation throughout the sample lifecycle.
Assign and maintain controlled sample storage locations across multiple temperature conditions to ensure proper organization and accessibility.
Store and retrieve samples from controlled storage units spanning 2–8°C, -20°C, and -80°C environments in accordance with approved procedures.
Coordinate the distribution of samples to laboratory groups according to approved sampling plans and requests, maintaining clear chain-of-custody at all times.
Maintain sample movement logs and chain-of-custody documentation from receipt through final disposition.
Manage retained sample inventory including long-term storage tracking and coordination of controlled disposal activities.
Support deviation investigations, temperature excursion events, and sample discrepancy resolution in close collaboration with QA and laboratory teams.
Perform periodic inventory reconciliation and support sample traceability checks to ensure records remain accurate and audit-ready.
Support internal audits, inspections, and QA oversight activities related to sample management operations.
Ensure all sample handling activities are performed in accordance with approved SOPs, Good Documentation Practices (GDP), and applicable regulatory expectations.
Maintain safe working practices at all times when handling temperature-controlled and potentially biohazardous materials.
Requirements:
Bachelor's degree in a life sciences discipline (Biology, Biochemistry, Chemistry, or related field), or equivalent combination of education and relevant work experience.
Minimum of 3 years of experience in a biotech, pharmaceutical, or clinical laboratory setting.
Foundational knowledge of GMP and/or GLP principles, including experience reading, following, and contributing to standard operating procedures.
Familiarity with Good Documentation Practices (GDP) and the importance of data integrity in a regulated environment.
Experience working in or with temperature-controlled storage environments (refrigerated, frozen, and/or ultra-low temperature conditions).
Strong attention to detail and organizational skills with the ability to manage multiple samples and priorities simultaneously.
Effective written and verbal communication skills for cross-functional collaboration with QA, laboratory, and operations teams.
Preferred:
Experience with electronic sample or laboratory tracking systems such as Benchling, LIMS, or comparable platforms.
Exposure to deviation or CAPA processes and supporting documentation.
Experience following SOPs and making process suggestions/improvements, where appropriate.
Familiarity with biohazardous material handling protocols and associated safety requirements.
Reports to: Director, Infrastructure & Capabilities
Location: San Carlos, CA
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):
Onsite (minimum of 4-5 days per week onsite)
Expected Contract Length: 12 Months
Hourly Range: $49 - $54
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases.
VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate being evaluated in the OPUS Phase 3 adult clinical program and in a Phase 2 infant clinical program, is being developed for the prevention of invasive pneumococcal disease (IPD) and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, a 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market. VAX-31 and VAX-24 are designed to improve upon standard-of-care PCVs by covering the serotypes in circulation that cause a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains. VAX-XL, in earlier-stage development, also leverages the Company’s carrier-sparing, site-specific conjugation technology with the aim of further expanding coverage to deliver the broadest-spectrum candidate in the Company’s PCV franchise.
Vaxcyte is re-engineering the way highly complex vaccines are made through XpressCF®, its cell-free protein synthesis platform exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to develop high-fidelity vaccines with enhanced immunological benefits.
Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections, and VAX-GI, a vaccine candidate designed to prevent Shigella.
Offices: 825 Industrial Rd, Suite 300, San Carlos, California 94070, US
Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases.
VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate being evaluated in the OPUS Phase 3 adult clinical program and in a Phase 2 infant clinical program, is being developed for the prevention of invasive pneumococcal disease (IPD) and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, a 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market. VAX-31 and VAX-24 are designed to improve upon standard-of-care PCVs by covering the serotypes in circulation that cause a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains. VAX-XL, in earlier-stage development, also leverages the Company’s carrier-sparing, site-specific conjugation technology with the aim of further expanding coverage to deliver the broadest-spectrum candidate in the Company’s PCV franchise.
Vaxcyte is re-engineering the way highly complex vaccines are made through XpressCF®, its cell-free protein synthesis platform exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to develop high-fidelity vaccines with enhanced immunological benefits.
Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections, and VAX-GI, a vaccine candidate designed to prevent Shigella.
Offices: 825 Industrial Rd, Suite 300, San Carlos, California 94070, US