Scientist II, Potency and Impurities

Just- Evotec Biologics is seeking a motivated and creative Scientist II 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 immunoassays (such as ELISAs) and qualification/validation, as well as strong experimental design and data analysis skills. Previous experience in late-stage and first-in-human (FIH) development and experience authoring regulatory documents is desirable. This person should have significant experience and understanding in formats such as ELISAs, AlphaLISA, and methods to characterize in-process impurities (such as residual host cell DNA, HCPs, and protein A leachate). 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.

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- Evotec’s Quality Control laboratory
• Participation in process development team(s), including potential for acting as functional lead
• Technology development to improve throughput and efficiency
• Present data to a wide range of audiences, including internal technical development teams, clients, industry conferences, and peer-reviewed journals
• Develop, qualify, and transfer immunoassays (e.g. ELISAs) for measuring potency and immunoassays and qPCR-based methods for use in measuring in-process impurities (e.g. residual protein A ELISA, HCP ELISA, and residual DNA qPCR method)

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Required Qualifications:

• PhD with 2+ years relevant direct industry experience, MS with 4+ years’ industry experience, or BS with 8+ years’ experience, with degrees in Biochemistry, Molecular and Cellular Biology, Chemical Engineering, Bioengineering, Chemistry or related field
• Experience developing analytical methods in a CMC or GMP-like industry setting
• General understanding of ICH/USP guidelines on analytical, in-process impurities, and potency assay development and validation
• Experience in the development, DOE robustness, and qualification and/or validation of release potency and impurities methods
• Strong technical understanding of link between MOA and analytical method development
• Experience developing and applying biological characterization methods (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 utilizing industry-standard analysis software (e.g. SoftMax Pro, JMP)
• Development of liquid-handling automation applications
• Development of kinetic potency assays (e.g. BLI/SPR)
• Experience with early & late stage regulatory filings 
• Experience in technology transfer
• Experience participating in CMC teams