Vaxcyte
Senior Manager, Quality Assurance(m/w/x)
Full-timeOn-siteSenior
Visp
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VAVaxcyte
Staff Engineer, Drug Substance, MSAT(m/w/x)
Visp
Full-timeOn-siteSenior
Nejo AI Summary
GMP manufacturing of protein-polysaccharide conjugate Drug Substances for vaccine portfolio. Statistical analysis using DOE planning and control charts required. Equity component, collaboration with 8 departments.
Requirements
- PhD in Bio/Chemical Engineering or Microbiology/Chemistry/Biochemistry with 9+ years Pharma/Biotech experience, or Master’s degree with 12+ years Pharma/Biotech experience
- Statistical thinking and data analysis capability
- Vaccine manufacturing operations experience preferred
- Drug Substance Manufacturing under GMP regulations
- Understanding of Quality systems
- Drug Substance manufacturing equipment specification and qualification preferred
- Scientific or technological (process engineering) background
- Hands-on experience with biochemical reaction, product recovery, and purification processes
- Commercial manufacturing experience preferred
- Deep knowledge of protein‑polysaccharide conjugation principles
- Understanding of CQAs and analytical characterization relevant to conjugates
- Sound knowledge of product recovery unit operations
- Sound knowledge of purification unit operations
- Troubleshooting equipment/technology and process
- Adept at FMEA
- Excellent analytic skills
- Experience in Investigations and CAPAs preferred
- Facility fit assessment, facility start-up, technology transfer, process validation, and scale-down studies implementing DOE desired
- Interpersonal and leadership skills
- Effective verbal and written communication skills
- Experience with Cross-Functional teams
- Managing direct reports
- Technical leadership skills
- Project management skills
- Fluency in spoken and written English highly preferred
Tasks
- Collaborate with program management, process development, quality, facilities, regulatory, finance, logistics, clinical supply, and CMO/supplier management.
- Ensure GMP manufacturing of protein-polysaccharide conjugate Drug Substances for Vaxcyte’s vaccine portfolio.
- Conduct statistical analysis using DOE planning, process capability, control charts, CPV trending, and data visualization.
- Oversee CMO service providers for commercial readiness, process validation, and commercial manufacturing campaigns.
- Participate in technology transfer, equipment/technology procurement, qualification, late-stage process characterization, and process validation.
- Conduct deviation and deficiency investigations and troubleshooting.
- Plan, design, execute, and document DS manufacturing process investigations and CAPAs.
- Drive continuous improvement and change management in DS manufacturing processes through technological innovation and first principles.
- Select new CMOs and suppliers.
- Leverage literature, industry/regulatory guidance, and practical experience to influence CMC strategies.
- Recommend and implement new technology to advance knowledge and productivity.
- Author and review technical reports, manufacturing documents, regulatory submissions, and publications.
- Present at department, project team, and senior management meetings; may present externally at scientific conferences.
- Support CMOs during health authority inspections and ensure follow-up on observations or recommendations.
Work Experience
- 9 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Tools & Technologies
- DOE
- GMP
Benefits
Competitive Pay
- Equity component
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Vaxcyte and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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VAVaxcyte
Staff Engineer, Drug Substance, MSAT(m/w/x)
Visp
Full-timeOn-siteSenior
Nejo AI Summary
GMP manufacturing of protein-polysaccharide conjugate Drug Substances for vaccine portfolio. Statistical analysis using DOE planning and control charts required. Equity component, collaboration with 8 departments.
Requirements
- PhD in Bio/Chemical Engineering or Microbiology/Chemistry/Biochemistry with 9+ years Pharma/Biotech experience, or Master’s degree with 12+ years Pharma/Biotech experience
- Statistical thinking and data analysis capability
- Vaccine manufacturing operations experience preferred
- Drug Substance Manufacturing under GMP regulations
- Understanding of Quality systems
- Drug Substance manufacturing equipment specification and qualification preferred
- Scientific or technological (process engineering) background
- Hands-on experience with biochemical reaction, product recovery, and purification processes
- Commercial manufacturing experience preferred
- Deep knowledge of protein‑polysaccharide conjugation principles
- Understanding of CQAs and analytical characterization relevant to conjugates
- Sound knowledge of product recovery unit operations
- Sound knowledge of purification unit operations
- Troubleshooting equipment/technology and process
- Adept at FMEA
- Excellent analytic skills
- Experience in Investigations and CAPAs preferred
- Facility fit assessment, facility start-up, technology transfer, process validation, and scale-down studies implementing DOE desired
- Interpersonal and leadership skills
- Effective verbal and written communication skills
- Experience with Cross-Functional teams
- Managing direct reports
- Technical leadership skills
- Project management skills
- Fluency in spoken and written English highly preferred
Tasks
- Collaborate with program management, process development, quality, facilities, regulatory, finance, logistics, clinical supply, and CMO/supplier management.
- Ensure GMP manufacturing of protein-polysaccharide conjugate Drug Substances for Vaxcyte’s vaccine portfolio.
- Conduct statistical analysis using DOE planning, process capability, control charts, CPV trending, and data visualization.
- Oversee CMO service providers for commercial readiness, process validation, and commercial manufacturing campaigns.
- Participate in technology transfer, equipment/technology procurement, qualification, late-stage process characterization, and process validation.
- Conduct deviation and deficiency investigations and troubleshooting.
- Plan, design, execute, and document DS manufacturing process investigations and CAPAs.
- Drive continuous improvement and change management in DS manufacturing processes through technological innovation and first principles.
- Select new CMOs and suppliers.
- Leverage literature, industry/regulatory guidance, and practical experience to influence CMC strategies.
- Recommend and implement new technology to advance knowledge and productivity.
- Author and review technical reports, manufacturing documents, regulatory submissions, and publications.
- Present at department, project team, and senior management meetings; may present externally at scientific conferences.
- Support CMOs during health authority inspections and ensure follow-up on observations or recommendations.
Work Experience
- 9 years
Education
- Doctoral / PhD
Languages
- English – Business Fluent
Tools & Technologies
- DOE
- GMP
Benefits
Competitive Pay
- Equity component
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Vaxcyte and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Vaxcyte
Industry
Pharmaceuticals
Description
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases.
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