Essential Functions:

• Help to define the scope of late-stage process development activities such as process characterization and development of scale-down models.  
• In concert with CMO, help to define the scope of PPQ activities. 
• Support scale-up activities and manufacture of Phase 3 and Commercial scale quantities of the VAX-24 Conjugate Drug Substances.  
• In concert with CMO, implement the appropriate equipment required to perform late-stage manufacturing.
• Contribute to CMO Manufacturing oversight via document review, person in plant responsibilities, and troubleshooting when necessary.  
• Facilitate cross-functional process risk analysis using appropriate tools such as FMEA, leading to the identification of CPPs and CQAs.  
• Present/communicate data to the Conjugation Development team.  

Requirements:

• PhD in Chemical/Biochemical Engineering or similar, MS with 2+ years of industry experience, or BS with 5+ 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) and practical experience with DoE software.
• Experience with late-stage process development activities such as risk assessments (e.g., FMEA) and identification of CPPs and CQAs is a plus.  
• Bioconjugate or protein purification knowledge and experience, including expertise in tangential flow filtration (TFF) 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 and independently to deliver results.  
• Strong interpersonal skills, with excellent written and verbal communication skills.