Sr. Scientist, Functional Biocharacterization

Just is seeking a motivated and creative scientist who desires a significant opportunity to improve worldwide access to biotherapeutics. The new scientist will join a fast-paced, collaborative, and multidisciplinary team to develop and execute methods for the functional assessment and impurity monitoring of biotherapeutics. As a key member of the analytical group, the successful candidate will have significant experience in cell-based, immunoassay, and qPCR method development and qualification/validation, as well as strong experimental design and data analysis skills. Previous experience in biosimilar development, participation in CMC teams and experience authoring regulatory documents highly desirable. The ideal candidate has strong written and verbal communication skills, multitasks effectively, works well independently and in teams and is excited about ways to improve technology.

Responsibilities:

• Work in teams for the functional characterization of early and late stage biotherapeutics
• Method development and qualification
• Participation in process development team(s)
• Biosimilarity and comparability assessments
• Technology transfer to Just's Quality Control laboratory
• Technology development to improve throughput and efficiency
• Author documents to support regulatory filings
• Mentor junior staff

Required Qualifications:

• PhD with 2 years industry experience, MS with 5+ years' industry experience, or BS with 12+ years' experience
• Experience in the development and qualification and/or validation of release potency and impurity methods (cell-based assays, immunoassays, and qPCR)
• Experience developing and applying biological characterization methods (e.g. cell-based assays, including primary cell assays, SPR or other protein binding kinetic assays, immunoassays, etc)
• Strong oral and written communication skills

Preferred Qualifications:

• Previous experience in biosimilar development
• Development of liquid-handling automation applications
• Experience with early & late stage regulatory filings
• Experience in technology transfer
• Experience participating in or leading CMC teams

About Just - Evotec Biologics

Just - Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 100 employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers