Research Engineer, Senior

Job description

• Establish a particle engineering laboratory; maintain particle manufacturing and testing equipment.
• Independently draft controlled documents such as batch records, SOPs, protocols, and reports related to vaccine process development/engineering and characterization. Provide support to transfer such documents and support technology transfer to cGMP contract manufacturers and other partners.
• Innovate novel vaccine delivery particle technologies suitable for domestic and global health use.
• Support patent applications describing novel particle technologies.
• Establish quality control assays and specifications for novel particle technologies and RNA-based vaccines suitable for preclinical use, and standards suitable for support of Phase 1 clinical trial materials consistent with FDA requirements for clinical vaccine products.
• Manufacture and perform quality control on vaccine products for preclinical use.
• Support the drafting of proposals for funding of continued work in the vaccine innovation space.
• Support the publication of journal articles resulting from the above activities.
• Other duties as assigned.
• PhD in relevant field and 3 years of relevant experience; OR
• Master’s Degree in relevant field and 5 years of relevant experience; OR
• Bachelor’s degree in relevant field and 7 years of relevant experience.
• Experience in manufacturing nanoemulsion-based vaccine components in a regulated environment.
• Experience in CMC (chemistry, manufacturing, and controls).
• Familiarity with cGMP vaccine manufacturing requirements.
• Direct experience with FDA requirements for Phase 1 clinical vaccine materials.
• Experience in designing and qualifying downstream purification methods for vaccine components, including ion exchange chromatography, tangential flow filtration, and sterile filtration.
• Laboratory and cGMP manufacturing of nanoemulsion-based vaccine components.
• Deep understanding of downstream purification processes suitable for release testing of vaccine products.
• Thorough understanding of CMC requirements for Phase 1/2 vaccine products.
• Willingness to work with pathogens potentially dangerous to humans.
• Willingness to work in Biosafety Level 2 and 3 facilities.
• Willingness and ability to work flexible hours.
• Ability and willingness to work independently
• Ability to carry and lift 35 lbs.
• Ability to stand for three continuous hours a day.
• Ability to work on computer for five continuous hours a day.
• Able to perform the essential functions of the position with or without accommodation.
• Industry experience in vaccine engineering, manufacturing, and/or quality control.
• Hands-on experience in cGMP manufacturing and tech transfer, including process qualification, in-process testing, and validation activities.
• Direct experience interacting with the US FDA regarding pre-IND and IND submissions in support of vaccine products.
• Experience directing technology transfer and scaleup from laboratory-scale vaccine manufacturing to cGMP.
• Experience with Design of Experiments (DOE) approaches for product and process optimization.
• Understanding of microfluidizer selection, installation, and function.
• Effective use of Design of Experiments software.
• Excellent verbal and written communication skills.
• PhD in relevant field and 3 years of relevant experience; OR
• Master’s Degree in relevant field and 5 years of relevant experience; OR
• Bachelor’s degree in relevant field and 7 years of relevant experience.
• Experience in manufacturing nanoemulsion-based vaccine components in a regulated environment.
• Experience in CMC (chemistry, manufacturing, and controls).
• Familiarity with cGMP vaccine manufacturing requirements.
• Direct experience with FDA requirements for Phase 1 clinical vaccine materials.
• Experience in designing and qualifying downstream purification methods for vaccine components, including ion exchange chromatography, tangential flow filtration, and sterile filtration.
• Laboratory and cGMP manufacturing of nanoemulsion-based vaccine components.
• Deep understanding of downstream purification processes suitable for release testing of vaccine products.
• Thorough understanding of CMC requirements for Phase 1/2 vaccine products.
• Willingness to work with pathogens potentially dangerous to humans.
• Willingness to work in Biosafety Level 2 and 3 facilities.
• Willingness and ability to work flexible hours.
• Ability and willingness to work independently
• Ability to carry and lift 35 lbs.
• Ability to stand for three continuous hours a day.
• Ability to work on computer for five continuous hours a day.
• Able to perform the essential functions of the position with or without accommodation.