Research Engineer, Senior at Oregon Health & Science University

Beaverton, Oregon, United States -

Full Time

Start Date

Immediate

Expiry Date

29 Jan, 26

Salary

0.0

Posted On

31 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Particle Engineering, Vaccine Process Development, cGMP Manufacturing, FDA Requirements, Downstream Purification, Quality Control, Nanoemulsion Manufacturing, Technology Transfer, Process Optimization, Design of Experiments, Communication Skills, Laboratory Skills, Regulatory Compliance, Immunology, Virology, Clinical Trials

Industry

Higher Education

Description

Department Overview The Vaccine and Gene Therapy Institute (VGTI) at Oregon Health & Science University (OHSU) has assembled a multidisciplinary team of scientists to respond to serious viral disease threats, including AIDS, chronic viral infection-associated diseases, newly emerging viral diseases and infectious diseases of the elderly. Our programs are intended to span the continuum between basic and clinical science, in which discoveries are rapidly advanced from the level of molecular and cellular biology through animal models and ultimately into clinical testing. The development of this unique program in immunology and virology provides an important training opportunity for graduate students and postdoctoral fellows aOHSUSU. This is why an important part of our mission is the training of young scientists in newer academic disciplines emerging at the Vaccine and Gene Therapy Institute. Function/Duties of Position 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. Required Qualifications 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. Preferred Qualifications 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. Additional Details Requirement to be onsite at the OHSU East Campus a minimum of 3 days per week. Occasional travel upon request. Ability to work with vaccine manufacturing equipment under high pressure, and in biological safety cabinets under BSL2 conditions with appropriate training provided. All are welcome Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.

Responsibilities

Establish a particle engineering laboratory and maintain particle manufacturing and testing equipment. Innovate novel vaccine delivery particle technologies and support the drafting of proposals for funding in the vaccine innovation space.