Research Engineer, Senior

• 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. • 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.