Senior/Principal Scientist, Potency, Functional Biocharacterization and Impurities

Company: Evotec WD
Location: Redmond
Posted on: March 20, 2023

Job Description:

Senior/Principal Scientist, Potency, Functional Biocharacterization and Impurities page is loaded Senior/Principal Scientist, Potency, Functional Biocharacterization and Impurities Apply locations Redmond Seattle time type Full time posted on Posted 2 Days Ago job requisition id JOB ID-07891 Just is seeking a motivated and creative senior or 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 assessment and impurity monitoring of biotherapeutics. - As a key leader in the analytical group, the successful candidate will have significant experience in cell-based bioassay, immunoassay, and qPCR -method development, strong experimental design and data analysis skills, and experience in method transfer, participation in CMC teams, authoring sections of regulatory filings, and recruiting, mentoring, developing, and supervising team members. Previous experience in biosimilar development, late-stage large molecule development, qualification/validation and leading CMC teams is highly desirable. The ideal candidate has strong written and verbal communication skills, multitasks effectively, exhibits strong leadership skills, and is excited about ways to improve technology. Responsibilities:

• Lead and develop a diverse group encompassing all aspects of biological assay development, including potency and characterization assays, qualification/validation of potency assays and method transfer to Quality Control and other Just-Evotec Biologics sites.
• Collaborate across the organization to speed time to clinic while reducing development costs
• Manage staff, capital resources and resource planning
• Serve as a technical resource on cross functional teams for biological characterization
• Author and review technical reports and author documents to support regulatory filings (including IND, INDa, BLA, IMPD)
• Act as an internal technical resource for Process Design, as well as a resource and subject matter expert for external clients and collaborators
• Present data to a wide range of audiences, including internal technical development teams, clients, industry conferences, and peer-reviewed journals
• Lead cross-functional teams and initiatives
• Supervise and develop the careers for direct reports Required Qualifications:
  • BS/MS in Biochemistry, Biology, Bioengineering or related field with 15+ years of experience or Ph.D. with 7+years of experience.
  • Expertise in the development, qualification and/or validation of release potency and impurity methods (cell-based assays, immunoassays, and qPCR)
  • Experience developing and applying early and late state biological characterization methods (e.g., cell-based assays, including primary cell assays, SPR or other protein binding kinetic assays, immunoassays, etc.)
  • 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
  • Strong mentoring, managerial, and leadership skills
  • Expertise in design of experiments (DOE) and statistical analysis
  • Experience participating in CMC development teams
  • Strong oral and written communication skills Preferred Qualifications:
    • Excellent understanding of ICH/USP guidelines on analytical, impurity, and potency assay development and validation
    • Previous experience in biosimilar development
    • Significant experience with early & late-stage regulatory filings
    • Experience leading 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. Similar Jobs (3) Principal Scientist, Bioreactor Process Design locations Redmond time type Full time posted on Posted 2 Days Ago Sr. Scientist/Principal Scientist- Bioreactor Process Design locations Seattle time type Full time posted on Posted 9 Days Ago About Us Evotec is a life science company with a unique business model focused on delivering highly effective new therapeutics to the patients. The Company leverages its multimodality platform, the "Data-driven R&D Autobahn to Cures", for proprietary projects and within a network of partners including Pharma, Biotech, academics, and other healthcare stakeholders. With more than 4,500 highly qualified people at 17 sites, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics. For additional information please go to www.evotec.com and follow us on Twitter @Evotec and LinkedIn . Please click on the link below to access and review our Privacy Information for Applicants: Privacy Information for Applicants

Keywords: Evotec WD, Redmond , Senior/Principal Scientist, Potency, Functional Biocharacterization and Impurities, Other , Redmond, Washington