Senior Scientist I, Functional Biocharacterization & Impurities

Just is seeking a motivated and creative Senior Scientist I who desires a significant opportunity to improve worldwide access to biotherapeutics. The candidate will join a fast-paced, collaborative, and multidisciplinary team to develop and execute methods for the functional and potency assessment and impurity monitoring of biotherapeutics.  As a key member of the analytical development group, the successful candidate will have significant experience in cell-based assay, 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 is highly desirable. The ideal candidate has strong written and verbal communication skill, multitasks effectively, works well independently and in teams, and is excited about ways to improve technology. The candidate may also be involved in leading cross-functional initiatives and supervising direct reports.

Responsibilities:

• Characterization of early and late stage biotherapeutics using diverse biological assay formats
• Lead and implement method development, DOE robustness, and qualification activities
• Technology transfer to Just’s Quality Control laboratory
• Technical document authoring
• Participation in process development team(s), including potential for acting as internal analytical team lead
• Biosimilarity and comparability assessments
• Technology development to improve throughput and efficiency
• Author and contribute to documents to support regulatory filings (including IND, INDa, BLA, IMPD)
• Mentor and train junior staff
• Present data to a wide range of audiences, including internal technical development teams, clients, industry conferences, and peer-reviewed journals
• Potential for leading cross-functional teams and initiatives
• Potential for supervising and developing the careers for direct reports

Required Qualifications:

• PhD with 3+ years relevant industry experience, MS with 5+ years’ industry experience, or BS with 10+ years’ experience
• Experience in the development, DOE robustness, and qualification and/or validation of release potency and impurity methods (cell-based assays, immunoassays, and qPCR)
• Strong technical understanding of link between MOA and analytical method development, and effects of impurities on biological manufacturing processes
• Experience in areas of technology development pertinent to impurities and potency assay development, including but not limited to assay automation and miniaturization, FcgR effector function assay development, large-scale cell banking, image and flow cytometry, and monitoring and characterization of diverse HCP’s
• Experience developing and applying biological characterization methods (e.g. cell-based assays, including primary cell assays, SPR or other protein binding kinetic assays, immunoassays, homogeneous assay formats such as AlphaLISA)
• Strong oral and written communication skills
• Desire to work in a fast, collaborative, and team-oriented environment

Preferred Qualifications:

• Experience developing analytical methods in a CMC or GMP-like industry setting preferred
• General understanding of ICH/USP guidelines on analytical, impurity, and potency assay development and validation
• Experience utilizing industry-standard analysis software (e.g. SoftMax Pro, JMP, Microsoft Office)
• 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 CMC teams

The base pay range for this position at commencement of employment is expected to be $124,000 to $140,000;  Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.