Staff Engineer, Drug Substance, MSAT

Summary:

Vaxcyte is looking for an energetic and talented individual to join the Manufacturing Science and Technology (MSAT) team in the role of Drug Substance (DS) Staff Engineer. The incumbent will support the conjugation manufacturing operations from commercial readiness through PPQ and ongoing commercial production, onsite at contract manufacturing organizations (CMO), with the primary responsibility to provide technical and operational support of manufacturing operations that ensure robust and efficient manufacturing processes. This position will primarily be located in Visp, Switzerland. 

This position will require the candidate to manage the highly complex conjugation manufacturing processes for Vaxcyte’s vaccine portfolio. This is an exciting opportunity to join an outstanding team, with a mission to support late-stage clinical manufacture, launch, and commercial operations for the PCV franchise.  The successful candidate will have the following skills and qualities:

• A skilled process engineer with expertise in:
  • Molecule activation and bioconjugation (e.g., activation chemistries, conjugation reaction kinetics, in-process controls, and common side reactions/impurities)
  • Strong quantitative skills: trend and multivariate analysis of process and analytical data to support continued process verification (CPV), deviation investigations, and process characterization (e.g., DOE).
• An exceptional team player who works seamlessly with others, speaks up, and remains focused on achieving the best results to attain company goals.
• The ability to analyze data and communicate conclusions, decisions and recommendations concisely to key stakeholders.
• A strong sense of ownership and accountability; commitment to Vaxcyte’s mission of protecting humankind.

Essential Functions:

• Work cross functionally with program management, process development, quality, facilities, regulatory, finance, logistics, clinical supply, and CMO / supplier management to ensure manufacture under GMP of different protein-polysaccharide conjugate Drug Substances required for Vaxcyte’s vaccine portfolio.
• Execute statistical thinking and data analysis using: DOE planning/analysis, process capability, control charts/CPV trending, and clear data visualization; proficiency with common tools.
• Oversight of CMO service provider(s) to ensure delivery of commercial readiness, process validation, and commercial stage manufacturing campaigns.
• Enable MSAT DS team participation in technology transfer, equipment/technology procurement and qualification, late-stage process characterization, process validation, and deviation and deficiency investigations and troubleshooting.
• Lead all aspects of and engage in the planning, design, execution, and documentation of DS manufacturing process Investigations and CAPAs.
• Drive continuous improvement and change management in DS manufacturing processes through technological innovation and application of first principles in process engineering.
• Support the process to select new CMOs and suppliers.
• Leverage literature, industry/regulatory guidance, and practical experience to perform work and influence CMC strategies.
• Recommend and implement new technology that advances knowledge and productivity within the department. Drive continuous improvement.
• 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 the CMOs during inspections of health authorities where necessary and ensure proper follow-up of any potential observation or recommendation.

Requirements: 

• PhD in Bio/Chemical Engineering or Microbiology/Chemistry/Biochemistry with 9+ years of relevant Pharma/Biotech industry experience, or Master’s degree in Bio/Chemical Engineering or Microbiology/Chemistry/ Biochemistry with 12+ years of relevant Pharma/Biotech industry experience. Other combinations of education and/or experience may be considered.
• Demonstrated capability in statistical thinking and data analysis: DOE planning/analysis, process capability, control charts/CPV trending, and clear data visualization; proficiency with common tools.
• Experience with Vaccine manufacturing operations preferred.
• Strong experience in Drug Substance Manufacturing under GMP regulations required. Understanding of Quality systems. Experience in Drug Substance manufacturing equipment specification and qualification preferred.
• Strong scientific or technological (process engineering) background and hands-on experience with biochemical reaction, product recovery, and purification processes. Commercial manufacturing experience preferred.
• Deep knowledge of protein‑polysaccharide conjugation principles (activation/coupling chemistries, reaction kinetics, impurity formation, and linkage distribution), plus understanding of CQAs and analytical characterization relevant to conjugates.
• Sound knowledge of product recovery unit operations such as homogenization/microfluidization, centrifugation, and depth filtration product purification unit operations such as chromatography, UF/DF TFF, and precipitation process analytics/control systems.
• Strong ability in troubleshooting equipment/technology and process. Adept at FMEA. Excellent analytic skills. Experience in Investigations and development and implementation of CAPAs preferred.
• Experience with facility fit assessment, facility start-up, technology transfer, process validation, and scale-down studies implementing DOE desired.
• Strong interpersonal and leadership skills. Ability to communicate effectively both verbally and in written formats. Experience with Cross-Functional teams and managing direct reports.
• Proven technical leadership skills including strong project management skills.
• Fluency in spoken and written English is highly preferred.