Senior Manager, Global Drug Substance Commercialization, Conjugation

About the Company

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. Our work is guided by core values of rethinking convention, aiming high, leading with heart, and modeling excellence.

Responsibilities

• Provide strategic and scientific leadership for polysaccharide to protein conjugation to ensure successful launch plans.
• Build and lead a highly-skilled global team focused on manufacturing processes.
• Continuously improve process understanding and robustness through monitoring and optimization.
• Collaborate with cross-functional teams including Regulatory, CMC, Quality, and Supply Chain.
• Support technical transfers, process validation, and comparability activities.
• Author and review regulatory filings (IND/BLA) and respond to Health Authority inquiries.
• Communicate process performance effectively to internal and external stakeholders.

Requirements

• Degree in Chemical/Biochemical Engineering, Chemistry, Biochemistry, or related discipline.
• 5+ years of experience for Ph.D., 8+ years for M.S., or 12+ years for B.S.
• Experience in development, tech transfer, scale-up, or production of polysaccharide/protein conjugate vaccines.
• Experience in MSAT or Process Development in supervisory or matrixed roles.
• Strong expertise in authoring Health Authority submissions (IND/BLA).
• Excellent strategic planning and problem-solving skills.
• Ability to travel 10-30%.

Preferred Qualifications

• Entrepreneurial approach to developing innovative ideas within the industry.
• Ability to analyze data from diverse sources to align with organizational strategy.