Staff Engineer, Drug Substance, MSAT

The company in Visp, Switzerland, seeks a Staff Engineer for its Drug Substance MSAT team to lead complex conjugation manufacturing processes and support commercial production readiness.

As a key member of the Manufacturing Science and Technology group, this position focuses on managing highly complex conjugation manufacturing processes for the company's vaccine portfolio. The role supports manufacturing operations from commercial readiness through ongoing production, ensuring the delivery of high-quality drug substances.

Responsibilities

• Collaborate with multiple internal departments, including program management, quality, regulatory, and supply chain, to ensure manufacturing adheres to Good Manufacturing Practices.
• Apply statistical methods and data analysis techniques, such as Design of Experiments, process capability studies, and control charting, to monitor and improve processes.
• Oversee Contract Manufacturing Organizations to guarantee successful commercial readiness, process validation, and execution of manufacturing campaigns.
• Facilitate technology transfers, equipment procurement and qualification, late-stage process characterization, and investigations into deviations.
• Lead the planning, design, and documentation of manufacturing process investigations and Corrective and Preventive Actions.
• Drive continuous improvement in manufacturing processes by applying engineering principles and technological innovations.
• Assist in the selection of new Contract Manufacturing Organizations and suppliers.
• Utilize industry guidance and practical expertise to shape CMC strategies.
• Recommend and implement new technologies to enhance departmental knowledge and productivity.
• Prepare and review technical reports, manufacturing documentation, regulatory submissions, and scientific publications.
• Present findings at internal meetings and potentially at external scientific conferences.
• Support Contract Manufacturing Organizations during regulatory inspections and ensure proper follow-up on observations.

Requirements

• A PhD in Biochemical Engineering, Microbiology, Chemistry, or Biochemistry with at least nine years of pharmaceutical or biotech industry experience, or a Master's degree with twelve or more years of relevant experience.
• Proven ability in statistical thinking and data analysis, including Design of Experiments, process capability, and data visualization.
• Extensive experience in Drug Substance manufacturing under Good Manufacturing Practice regulations.
• Strong background in process engineering with hands-on experience in biochemical reactions, product recovery, and purification.
• In-depth knowledge of protein-polysaccharide conjugation principles, including activation chemistries, reaction kinetics, and analytical characterization.
• Familiarity with product recovery unit operations like homogenization, centrifugation, and depth filtration, as well as purification processes such as chromatography and ultrafiltration/diafiltration.
• Strong troubleshooting skills for equipment and processes, with proficiency in Failure Mode and Effects Analysis.
• Experience in facility fit assessment, start-up, technology transfer, process validation, and scale-down studies.
• Excellent interpersonal and leadership abilities, with experience managing direct reports and working in cross-functional teams.
• Proven technical and project management leadership skills.

Nice to have

• Prior experience in vaccine manufacturing operations.
• Experience with Drug Substance manufacturing equipment specification and qualification.
• Background in commercial manufacturing.
• Experience in conducting investigations and implementing Corrective and Preventive Actions.
• Fluency in spoken and written English.

What the company offers

• A competitive compensation package that includes an equity component.

About the company

Vaxcyte is a clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines to protect humanity from bacterial diseases. The organization's work is guided by four enduring core values: Rethink Convention, Aim High, Lead with Heart, and Model Excellence.

• Rethink Convention
• Aim High
• Lead with Heart
• Model Excellence