Sr. Engineer, Conjugation Development and Clinical Manufacturing

$152,000 - $170,000/Yr

Vaxcyte - San Carlos, CA

Full-time - Senior

San Carlos, CA

Professional, Scientific, and Technical Services

About the position

The Sr. Engineer in Conjugation Development and Clinical Manufacturing at Vaxcyte, Inc. plays a crucial role in the late-stage process development of vaccine manufacturing. This position focuses on executing process characterization strategies and overseeing contract manufacturing organizations (CMOs) to ensure successful production of conjugate drug substances. The role requires collaboration with cross-functional teams and involves mentoring junior team members while contributing to the overall mission of developing innovative vaccines to combat bacterial diseases.

Responsibilities

• Define the scope and strategy of late-stage process development activities such as process characterization and development of scale-down models.
• Collaborate with CMO to define the scope and strategy of PPQ activities.
• Lead scale-up activities to support the manufacture of Phase 3 and Commercial scale quantities of the VAX-24 Conjugate Drug Substances.
• Identify and implement appropriate equipment for late-stage manufacturing in collaboration with CMO.
• Contribute to CMO Manufacturing oversight through document review and troubleshooting as necessary.
• Facilitate cross-functional process risk analysis using tools such as FMEA to identify CPPs and CQAs.
• Present and communicate data to the Conjugation Development team and broader CMC team.
• Guide and mentor junior team members.

Requirements

• PhD in Chemical/Biochemical Engineering or similar with 2+ years of industry experience; MS with 5+ years; or BS with 10+ years of industry experience.
• Practical experience and theoretical knowledge of engineering principles for scaling processes from development lab to manufacturing plant.
• Working knowledge of GMP manufacturing requirements, preferably with hands-on GMP experience.
• Experience working with CMOs and ability to oversee development and manufacturing activities at CMO, including some international travel.
• Solid understanding of DoE principles and practical experience with DoE software.
• Experience with late-stage process development activities such as risk assessments and identification of CPPs and CQAs is a plus.
• Experience writing IND sections is a plus.
• Knowledge and experience in bioconjugate or protein purification, including tangential flow filtration (TFF) and process scaling.
• Demonstrated success in a cross-functional team environment on multiple projects.

Nice-to-haves

• Experience with late-stage process development activities such as risk assessments (e.g., FMEA) and identification of CPPs and CQAs.
• Experience writing IND sections.
• Bioconjugate or protein purification knowledge and experience, including expertise in tangential flow filtration (TFF), process scaling, and optimization.

Benefits

• Competitive salary package
• Comprehensive benefits
• Equity component