Senior Engineer, Conjugation Development

Summary

The Development organization is comprised of four Process teams: Protein, Polysaccharide, Conjugate Drug Substance (Conjugation), and Drug Product. These Process Development teams are supported by Analytical Development and Formulation Development teams. Vaxcyte is looking for a Sr. Engineer with experience in campaign support, tech transfer, and GMP/regulatory authoring to join the Conjugation engineering team. The candidate will manage the TFF and dead end filtration operations of our CMO partners, transfer new conjugation processes from the San Carlos labs to a CDMO, and generate documentation supporting our regulatory filings.

Essential Functions

• Lead all pre-commercial CDMO TFF and filtration operations across our conjugation network, and provide technical support to our commercial operation partners
• Contribute to CMO manufacturing preparation and oversight via document authoring, document review, person in plant responsibilities, and troubleshooting when necessary
• Develop data analytics platforms to trend and summarize GMP and Commercial process performance, enabling both process optimization as well as Continued Process Verification
• Support scale-up activities and tech transfer of early phase clinical candidates to an external CMO
• Facilitate cross-functional process risk analysis using appropriate tools such as FMEA
• Present/communicate data to the Conjugation Development team as well as broader CMC team
• Collate data and author supplementary documents for BLA, CPV, and other regulatory interactions
• Serve as a guide and mentor to junior team members

Requirements

• 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