Vaxcyte Senior Engineer, Conjugation Development at Vaxcyte manages TFF and filtration operations and supports tech transfer to CDMOs. Responsible for regulatory documentation and providing technical support across conjugation network.
Responsibilities
Lead pre-commercial CDMO TFF and filtration operations
Provide technical support to commercial operation partners
Contribute to CMO manufacturing preparation and oversight
Develop data analytics platforms for process performance
Support scale-up activities and tech transfer to external CMO
Facilitate cross-functional process risk analysis
Present data to Conjugation Development and broader CMC teams
Author supplementary documents for regulatory interactions
Mentor junior team members
Qualification
Experience writing INDGeneral regulatory experience is a plusStrong interpersonal skills
Required
PhD in Chemical/Biochemical Engineering or similar, with 2+ years of industry experience; MS with 5+ years of industry experience; or BS with 10+ years of industry experience
Both practical experience with and theoretical knowledge of engineering principles involved in scaling processes from development lab to pilot / manufacturing plant
Working knowledge of the requirements of GMP manufacturing, preferably with hands on GMP experience through either a Manufacturing or MSAT role
Experience working with CMOs highly desired; ability to effectively transfer processes to CMO, and to oversee development and manufacturing activities performed at CMO; ability to travel to CMO (some international travel required) to perform person-in-plant oversight activities
Solid understanding of the principals of DoE (Design of Experiments)
Experience with late-stage process development activities such as risk assessments (e.g., FMEA) and identification of CPPs and CQAs is a plus
Experience writing IND, BLA, or CPV sections is a plus
General regulatory experience is a plus
Expertise in tangential flow filtration (TFF) and dead end filtrations
Bioconjugate or protein purification knowledge and experience, process scaling and optimization, and reactor scale up is a plus
Demonstrated success working in a cross-functional team environment on multiple projects; ability to work both on a team (as member and/or leader) and independently to deliver results
Strong interpersonal skills, with excellent written and verbal communication skills
