Senior Manager, Global Drug Substance Commercialization, Conjugation

Responsibilities

• Provide strategic and scientific leadership for polysaccharide to protein conjugation to ensure successful execution of launch plans and post-launch commercial activities.
• Lead technical launch planning and execution, coordinating cross-functional efforts for regulatory filings, facility readiness, and launch supplies.
• Author and technically review regulatory filings (IND/BLA) and respond to Health Authority inquiries.
• Drive the transition of conjugate product strategy from Process Development to Manufacturing Science and Technology (MSAT).
• Collaborate with cross-functional teams including Regulatory, CMC, Quality, Supply Chain, and Process Engineering to support technology transfer and scale-up.
• Support process validation, comparability activities, and continuous improvement of process robustness throughout the product lifecycle.
• Manage relationships with internal stakeholders and external CMOs, communicating scientific and commercial rationales effectively.

Requirements

• Degree in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or a related discipline.
• Experience requirements based on education level:
• Ph.D.: 5+ years of relevant experience
• M.S./M.A.: 8+ years of relevant experience
• B.S./B.A.: 12+ years of relevant experience
• Proven experience in the development, tech transfer, scale-up, or production of polysaccharide/protein conjugate vaccines.
• Experience in MSAT or Process Development within supervisory or matrixed team roles.
• Strong technical writing skills, specifically for Health Authority submissions.
• Ability to travel 10-30%.

About the Company

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. We are driven by core values of rethinking convention, aiming high, leading with heart, and modeling excellence to tackle the most complex biologics in the industry.