Job Description

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: