Principal 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 build and lead a group to develop and execute methods for the functional assessment and impurity monitoring of biotherapeutics. As a key leader in the analytical group, the successful candidate will have significant experience in cell-based, immunoassay, and qPCR method development and qualification/validation, strong experimental design and data analysis skills, participation in CMC teams, experience authoring sections of regulatory filings, and experience recruiting, mentoring, developing, and supervising team members. Previous experience in biosimilar development and leading CMC teams highly desirable. The ideal candidate has strong written and verbal communication skills, multitasks effectively, exhibits strong leadership skills, and is excited about ways to improve technology.

Responsibilities:

• Build and lead a diverse group encompassing all aspects of biological assay development, including potency and characterization assays, qualification/validation of potency assays and tech transfer to Quality Control
• Collaborate across the organization to speed time to clinic while reducing development costs
• Manage staff, capital resources and planning
• Serve as a technical resource on cross functional teams for biological characterization
• Author CMC regulatory sections
• Act as an internal technical resource for Process Design, as well as a resource and subject matter expert for external clients and collaborators

Required Qualifications:

• BS/MS in Biochemistry, Biology, Bioengineering or related field with 15+ years of experience or Ph.D. with 7+years of experience.
• Expertise in the development and qualification and/or validation of release potency and impurity methods (cell-based assays, immunoassays, and qPCR)
• Experience developing and applying early and late state biological characterization methods (e.g. cell-based assays, including primary cell assays, SPR or other protein binding kinetic assays, immunoassays, etc)
• Strong mentoring, managerial, and leadership skills
• Expertise in design of experiments (DOE) and statistical analysis
• Experience participating in CMC development teams
• Strong oral and written communication skills

Preferred Qualifications:

• Previous experience in biosimilar development
• Experience with early & late stage regulatory filings
• Experience 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