Principal Scientist, Potency and Impurities
3 weeks ago
- 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 analytical team lead and interfacing both internally and externally to clients
- 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.
- Lead immunoassay and cell-based potency method development and testing
- Lead cross-functional teams and initiatives.
- Supervise and develop the careers for 1-2 direct reports.
- BS/MS in Biochemistry, Biology, Bioengineering or related field with 15+ years of experience or Ph.D. with 6+years of experience.
- Experience developing analytical methods in a CMC or GMP-like industry setting.
- Excellent understanding of ICH/USP guidelines on analytical, impurity, and potency assay development and validation.
- Experience in the development, DOE robustness, and qualification and/or validation of release potency and impurity methods (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 and monitoring and characterization of diverse HCP's
- Experience developing and applying biological characterization methods (e.g. cell-based assays, SPR/BLI or other protein binding kinetic assays, immunoassays, homogeneous assay formats such as AlphaLISA).
- Experience utilizing industry-standard analysis software (e.g. SoftMax Pro, JMP)
- Development of liquid-handling automation applications
- Experience with early & late stage regulatory filings
- Experience with kinetic assay development (SPR, BLI, etc)
- Experience in technology transfer
- Experience participating in CMC teams
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Principal Scientist, Potency and Impurities
7 days ago
Seattle, WA, United States Evotec Group Full timePrincipal Scientist, Potency and Impurities Just- Evotec Biologics is seeking a motivated and creative Principal Scientist 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...
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Principal Scientist, Potency and Impurities
2 weeks ago
Seattle, United States Evotec SE Full timePrincipal Scientist, Potency and Impurities Just- Evotec Biologics is seeking a motivated and creative Principal Scientist 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...
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Principal Scientist, Potency and Impurities
2 weeks ago
Seattle, United States Evotec Full timePrincipal Scientist, Potency and Impurities Just- Evotec Biologics is seeking a motivated and creative Principal Scientist 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...
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