Scientist II, Potency and Impurities

4 weeks ago

Redmond, United States Evotec Full time

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)

​

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

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.

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