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Vaxcyte, a clinical-stage vaccine innovation company, is seeking a Senior Bioprocess Engineer II to join the Manufacturing Science and Technology (MSAT) team. The role focuses on supporting microbial manufacturing operations for the company's vaccine portfolio, from commercial readiness through process performance qualification (PPQ) and ongoing commercial production.
The position is primarily based in Visp, Switzerland, with oversight responsibilities for contract manufacturing organizations (CMOs) in Italy and Germany. This is a hybrid role requiring a minimum of 3 days per week onsite.
Key Responsibilities:
- Manage highly complex microbial manufacturing processes for Vaxcyte's vaccine portfolio, particularly polysaccharide intermediates
- Provide technical and operational support to CMO service providers, ensuring delivery of commercial readiness, process validation, and commercial-stage manufacturing campaigns
- Work cross-functionally with program management, process development, quality, facilities, regulatory, finance, logistics, and clinical supply teams
- Lead planning, design, execution, and documentation of manufacturing process investigations and corrective/preventive actions (CAPAs)
- Drive continuous improvement and change management through technological innovation and first-principles process engineering
- Support CMO selection and supplier qualification processes
- Participate in technology transfer, equipment procurement and qualification, and late-stage process characterization
- Author and review technical reports, manufacturing documents, and regulatory submissions
- Present findings at department, project team, and senior management meetings; may present at scientific conferences
- Support CMOs during health authority inspections and ensure proper follow-up on observations
Required Qualifications:
- PhD in Bio/Chemical Engineering or Microbiology/Chemistry/Biochemistry with 8+ years of relevant Pharma/Biotech industry experience, OR Master's degree in Bio/Chemical Engineering or Microbiology/Chemistry/Biochemistry with 5+ years of relevant Pharma/Biotech industry experience
- Strong experience in Drug Substance Manufacturing under GMP regulations
- Strong scientific or technological (process engineering) background with hands-on experience in bacterial fermentation, product recovery, and purification processes
- Deep knowledge of protein-polysaccharide conjugation principles OR in-depth understanding of bacterial fermentation principles, bioreactor systems, and process analytics/control systems
- Sound knowledge of product recovery unit operations (homogenization/microfluidization, centrifugation, depth filtration) and product purification unit operations (chromatography, UF/DF TFF, precipitation)
- Strong troubleshooting skills, FMEA competency, and excellent analytical abilities
- Experience with facility fit assessment, facility start-up, technology transfer, process validation, and scale-down studies implementing DOE
- Strong interpersonal and leadership skills with proven technical leadership and project management capabilities
- Fluency in spoken and written English (mandatory)
Preferred Qualifications:
- Experience with vaccine manufacturing operations
- Understanding of quality systems and experience in Drug Substance manufacturing equipment specification and qualification
- Commercial manufacturing experience
- Experience with cell-free upstream technology
- Experience with investigations and development/implementation of CAPAs
- Experience managing direct reports
