Senior Engineer, Conjugation Development

The role

You will lead pre-commercial CDMO tangential flow filtration (TFF) and filtration operations for the conjugation network. You will support tech transfer of early phase clinical candidates to an external CMO and help author documents for regulatory filings.

What you will do

• Lead all pre-commercial CDMO TFF and filtration operations across the conjugation network
• Provide technical support to commercial operation partners
• Contribute to CMO manufacturing preparation and oversight, including document authoring and review
• Serve on site at CMOs and troubleshoot when necessary
• Develop data analytics platforms to trend GMP and commercial process performance
• Support scale-up and tech transfer of early phase clinical candidates to an external CMO
• Facilitate cross-functional process risk analysis using tools such as FMEA
• Present and communicate data to the Conjugation Development team and the broader CMC team
• Collate data and author supplementary documents for BLA, CPV, and other regulatory interactions
• Mentor junior team members

Required qualifications

• PhD in Chemical/Biochemical Engineering or similar with 2+ years of industry experience, or MS with 5+ years of industry experience, or BS with 10+ years of industry experience
• Practical experience and theoretical knowledge of engineering principles for scaling processes from lab to pilot or manufacturing plant
• Working knowledge of GMP manufacturing requirements
• Solid understanding of the principles of Design of Experiments (DoE)
• Expertise in tangential flow filtration (TFF) and dead end filtration
• Ability to transfer processes to a CMO and oversee its development and manufacturing activities
• Ability to travel to CMOs, including some international travel
• Demonstrated success working in cross-functional teams on multiple projects, both as a member or leader and independently
• Strong interpersonal, written, and verbal communication skills

Nice to have

• Experience working with CMOs
• Hands-on GMP experience through a Manufacturing or MSAT role
• Experience with late-stage process development such as FMEA and identification of CPPs and CQAs
• Experience writing IND, BLA, or CPV sections
• General regulatory experience
• Bioconjugate or protein purification knowledge, process scaling and optimization, and reactor scale-up

Benefits

• Comprehensive benefits
• Equity component

Before you apply

• Some international travel to CMO sites is required
• Onsite at least 4 days per week

About the company

Vaxcyte is a clinical-stage vaccine innovation company developing vaccines against bacterial diseases such as invasive pneumococcal disease, Group A Strep, and Shigella. The company is an equal opportunity employer.