... within Vaxcyte QA and with outside collaborators, building partnerships that support analytical ... Partner with QC, vendor management, and contract labs to set key performance indicators for ...
60 Vaxcyte Quality Control Analyst Jobs Hiring Near You
... within Vaxcyte QA and with outside collaborators, building partnerships that support analytical ... Partner with QC, vendor management, and contract labs to set key performance indicators for ...
Sr. Director, Quality Assurance for Quality Control
San Carlos, CA · On-site +1
$229K - $268K/yr
... within Vaxcyte QA and with outside collaborators, building partnerships that support analytical ... Partner with QC, vendor management, and contract labs to set key performance indicators for ...
Sr. Director, Quality Assurance for Quality Control
San Carlos, CA · On-site +1
$229K - $268K/yr
... within Vaxcyte QA and with outside collaborators, building partnerships that support analytical ... Partner with QC, vendor management, and contract labs to set key performance indicators for ...
Senior Manager, Microbiology Support for Global ASAT
San Carlos, CA · On-site
$166K - $194K/yr
The primary responsibility will include supporting the microbiological quality control activities including cGMP analytical testing at Contract Testing Organizations and Vaxcyte QC laboratory ...
Senior Manager, Microbiology Support for Global ASAT
San Carlos, CA · On-site
$166K - $194K/yr
The primary responsibility will include supporting the microbiological quality control activities including cGMP analytical testing at Contract Testing Organizations and Vaxcyte QC laboratory ...
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Champion cross-functional analytical strategies between development, QC, regulatory, and ...
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Champion cross-functional analytical strategies between development, QC, regulatory, and ...
The primary responsibility will include supporting the microbiological quality control activities including cGMP analytical testing at Contract Testing Organizations and Vaxcyte QC laboratory ...
The primary responsibility will include supporting the microbiological quality control activities including cGMP analytical testing at Contract Testing Organizations and Vaxcyte QC laboratory ...
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... cause analysis, and sustainable CAPAs. * Provide oversight and decision authority for batch ...
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... cause analysis, and sustainable CAPAs. * Provide oversight and decision authority for batch ...
Associate Director, QC Global Analytics
San Carlos, CA · On-site +1
$176K - $206K/yr
Vaxcyte internal analytical contact for all functional stakeholders. Operational Oversight ... Senior Director, Quality Control Location: San Carlos, CA Work Arrangement (may be adjusted based ...
Associate Director, QC Global Analytics
San Carlos, CA · On-site +1
$176K - $206K/yr
Vaxcyte internal analytical contact for all functional stakeholders. Operational Oversight ... Senior Director, Quality Control Location: San Carlos, CA Work Arrangement (may be adjusted based ...
... Vaxcyte's global network of Contract Development and Manufacturing Organizations (CDMOs) and ... cause analysis, and sustainable CAPAs. * Provide oversight and decision authority for batch ...
... Vaxcyte's global network of Contract Development and Manufacturing Organizations (CDMOs) and ... cause analysis, and sustainable CAPAs. * Provide oversight and decision authority for batch ...
Stability Manager
San Carlos, CA · On-site
$134K - $162K/yr
... analysis. This individual will collaborate with QC members in a highly collaborative and cross ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
Stability Manager
San Carlos, CA · On-site
$134K - $162K/yr
... analysis. This individual will collaborate with QC members in a highly collaborative and cross ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
Vaxcyte is seeking an accomplished Associate Director, Immunoassay Development to join the CMC ... Analytical Development, ASAT, QC, Process Development, Manufacturing, Quality, Clinical Serology ...
Vaxcyte is seeking an accomplished Associate Director, Immunoassay Development to join the CMC ... Analytical Development, ASAT, QC, Process Development, Manufacturing, Quality, Clinical Serology ...
... development, QC, or related field. Other combinations of education and/or experience may be ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
... development, QC, or related field. Other combinations of education and/or experience may be ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
Summary: Vaxcyte is seeking an accomplished Director, Immunoassay Development to join the CMC ... analytical activities. * Support QC and ASAT teams in technical questions related to release ...
Summary: Vaxcyte is seeking an accomplished Director, Immunoassay Development to join the CMC ... analytical activities. * Support QC and ASAT teams in technical questions related to release ...
... Analytical Development, ASAT, QC, Process Development, Manufacturing, Quality, Clinical Serology ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
... Analytical Development, ASAT, QC, Process Development, Manufacturing, Quality, Clinical Serology ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
Scientist I, Drug Product Analytics
San Carlos, CA · On-site
$129K - $140K/yr
... Quality, and external partners. * Vaxcyte is seeking a flexible and collaborative scientist ... C samples, calibrators, amongst others * Experience analyzing and visualizing bioassay data using ...
Scientist I, Drug Product Analytics
San Carlos, CA · On-site
$129K - $140K/yr
... Quality, and external partners. * Vaxcyte is seeking a flexible and collaborative scientist ... C samples, calibrators, amongst others * Experience analyzing and visualizing bioassay data using ...
... analytical development, QC, ASAT, bioanalytical development, or other analytical laboratory ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
... analytical development, QC, ASAT, bioanalytical development, or other analytical laboratory ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
... analytical activities. * Support QC and ASAT teams in technical questions related to release ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
... analytical activities. * Support QC and ASAT teams in technical questions related to release ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
Stability Manager
$147K - $171K/yr
Vaxcyte is looking for an energetic and talented individual to join Vaxcyte's Vaccine Product ... analysis. This individual will collaborate with QC members in a highly collaborative and cross ...
Stability Manager
$147K - $171K/yr
Vaxcyte is looking for an energetic and talented individual to join Vaxcyte's Vaccine Product ... analysis. This individual will collaborate with QC members in a highly collaborative and cross ...
Vaxcyte is looking for an energetic and talented individual to join Vaxcyte's Global Analytical ... QA, RA, Manufacturing, and external partners to align statistical rationale with CMC control ...
Vaxcyte is looking for an energetic and talented individual to join Vaxcyte's Global Analytical ... QA, RA, Manufacturing, and external partners to align statistical rationale with CMC control ...
MS with 5+ years; BS with 8+ years of relevant industry experience in analytical development, QC, ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
MS with 5+ years; BS with 8+ years of relevant industry experience in analytical development, QC, ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
Develop and mature the physical security function at Vaxcyte, including access control and ... Lead and manage a team of security analysts and operators to the operation of a GSOC. * Provide ...
Develop and mature the physical security function at Vaxcyte, including access control and ... Lead and manage a team of security analysts and operators to the operation of a GSOC. * Provide ...
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Full-time
Re-posted 10 days ago
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:
This role is pivotal in ensuring compliance with global regulatory guidelines and supporting our pipeline of high-fidelity vaccines. Vaxcyte is looking for an energetic and talented individual to join our Quality Assurance team as a Senior Director. This role carries dual accountability: providing direct QA support to the analytical operations based in Switzerland, while also managing the San Carlos-based QA team responsible for oversight of smaller-scale analytical activities. The Senior Director will be expected to operate effectively across both sites, navigating the distinct regulatory environments and operational cadences of each. The primary responsibility will be the QA oversight of QC activities associated with Vaxcyte's PCV Polysaccharides and Drug Substances. The Senior Director will work closely with internal teams (Process Development, MSAT, Quality Control, Regulatory, and Stability) and external partners (CDMOs and CTLs) to maintain the compliance of the analytical program.
Essential Functions:
Requirements:
Bachelor's degree in Biochemistry, Chemistry, or a related field with 15+ years of relevant industry experience. Other combinations of education and/or experience may be considered.
Reports to: Executive Director, Quality Assurance
Location: Raleigh, NC
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote
Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $229,000 - $268,000 (North Carolina)
Equal Opportunity
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.
Recruitment Fraud Notice
Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at vaxcyte.com/careers.
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:
This role is pivotal in ensuring compliance with global regulatory guidelines and supporting our pipeline of high-fidelity vaccines. Vaxcyte is looking for an energetic and talented individual to join our Quality Assurance team as a Senior Director. This role carries dual accountability: providing direct QA support to the analytical operations based in Switzerland, while also managing the San Carlos-based QA team responsible for oversight of smaller-scale analytical activities. The Senior Director will be expected to operate effectively across both sites, navigating the distinct regulatory environments and operational cadences of each. The primary responsibility will be the QA oversight of QC activities associated with Vaxcyte's PCV Polysaccharides and Drug Substances. The Senior Director will work closely with internal teams (Process Development, MSAT, Quality Control, Regulatory, and Stability) and external partners (CDMOs and CTLs) to maintain the compliance of the analytical program.
Essential Functions:
- Lead quality oversight activities related to method validation, release and in-process testing for Drug Substance and Polysaccharide
- Serve as the primary liaison within Vaxcyte QA and with outside collaborators, building partnerships that support analytical needs for relevant programs.
- Represent QA at internal and external cross functional team meetings.
- Lead review and approval of internal and external GMP documentation for compliance, including specifications, Certificates of Analysis, validation reports, deviations, change controls, risk assessments, and CAPAs as they relate to polysaccharides and drug substance; apply technical and compliance expertise to critically evaluate reference standards, test methods, protocols, and raw data packages from CMOs and contract testing laboratories.
- Partner with QC, vendor management, and contract labs to set key performance indicators for monitoring vendor effectiveness.
- Drive resolution of quality performance issues with contract manufacturers and testing organizations
- Review Quality Agreements and regulatory documentation as required.
- Lead quality investigations of testing deviations and OOS.
- Contribute to regulatory filings, respond to questions from health authorities, and ensure quality of documentation used in support of regulatory submissions.
- Take part in audit preparations and help ensure ongoing readiness.
- Develop, review, and update GMP-related internal policies and procedures as necessary.
- Champion a culture of quality excellence and continuous improvement by proactively identifying systemic gaps, driving implementation of sustainable solutions, and establishing performance standards that elevate GMP compliance across internal teams and external partners.
Requirements:
Bachelor's degree in Biochemistry, Chemistry, or a related field with 15+ years of relevant industry experience. Other combinations of education and/or experience may be considered.
- Thorough knowledge of applicable FDA, EU, and ICH regulatory guidelines and pharmacopeia for method qualification and validation in biologics and vaccines, along with proven expertise in applying these regulations to develop practical solutions and phase-appropriate analytical strategies.
- Experience working with biochemistry, immunoassay, or microbiological assay techniques in a Quality Control environment.
- Excellent organizational and project management skills, with the ability to handle multiple projects under tight timelines.
- Excellent written and verbal communication skills, including the ability to work effectively in cross-functional teams.
- Previous experience in validation and transfer of analytical assays.
- Demonstrated ability to build and develop high-performing QA teams and influencing cross-functional and executive stakeholders in a fast-paced commercial-stage biotech company.
- Knowledge and experience in Risk Management principles.
- Knowledge in both clinical and commercial product desired.
- Ability to integrate and interpret interdisciplinary project information; with at least a high-level understanding of the drug/vaccine development process.
- Ability to work globally with CMOs in different countries and continents.
- Experience managing geographically distributed QA teams across multiple sites or countries, with the ability to build cohesive quality culture and consistent GMP standards across locations.
- Experience in BLA submission and commercial launch is highly desirable
Reports to: Executive Director, Quality Assurance
Location: Raleigh, NC
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote
Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $229,000 - $268,000 (North Carolina)
Equal Opportunity
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.
Recruitment Fraud Notice
Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at vaxcyte.com/careers.
About Vaxcyte
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
San Carlos, CA, US
Year founded
2013