- 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)
- 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
- 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
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Associate Scientist, Potency and Impurities
1 week ago
Evotec Redmond, United States$48,510 · $90,090 · Just-Evotec Biologics is seeking a motivated and creative Associate Scientist who desires an opportunity to improve worldwide access to biotherapeutics. You will have the opportunity to collaborate with a multidisciplinary team develop and execute methods for ...
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Principal Scientist, Potency and Impurities
2 weeks ago
Evotec WD Seattle, WA, United StatesPrincipal Scientist, Potency and Impurities page is loaded · Principal Scientist, Potency and Impurities · Apply locations Seattle time type Full time posted on Posted 2 Days Ago job requisition id JOB ID-09696 Principal Scientist, Potency and Impurities · Just- Evotec Biolog ...
Scientist II, Potency and Impurities - Redmond, United States - Evotec
Description
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:
Required Qualifications:
Preferred Qualifications:
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.
