Prothena

Scientist, Bioanalytical Assays

US-CA-South San Francisco
Job ID
2017-1158
Category
Research & Development

Overview

The ideal candidate will bring his/her experience with assay design, development, and implementation and become part of a team supporting the development of therapeutic antibodies.  The individual will support the group with both the management and hands-on efforts necessary to develop bioanalytical assays for both pre-clinical and clinical programs. The individual must be collaborative, team-oriented and enjoy the fast-paced, multi-tasked, and hands-on research environment of a science and patient-centric company. This role will have the opportunity for significant career development/progression opportunities as our business continues to grow and expand.

Responsibilities

  • Lead, develop, and mentor a high performing bioanalytical team
  • Hands on experience in designing, developing and troubleshooting methods for pharmacokinetic, pharmacodynamic, anti-drug antibodies (ADA and Cell based Nab assays), biomarkers and potency assay that are suitable for use in GxP and clinical studies
  • Experienced in discovering and developing biomarker assays
  • Initiate and Manage relationships with Contract Research Organizations (CROs) for method transfer, validation, sample analysis and report generation
  • Experience in and knowledge of industry guidance for the development and validation of pK, immunogenicity immunoassays and bioassays, biomarkers and/or potency assays
  • Prepare reports, regulatory documents (e.g. INDs and BLAs)
  • Partner cross functionally with multidisciplinary areas within research, clinical, regulatory and QA/QC across multiple programs.

Qualifications

  • Minimum PhD with 2+ years applicable experience or BS/MS with >10 years applicable experience
  • Proven track record of scientific, managerial, and collaboration work
  • Extensive hands-on experience with the design, development, optimization, qualification and validation of novel immunoassays and bioassays across multiple platforms and technologies (eg, ELISA, MSD, AlphaScreen, flow cytometry; cell based, etc.)
  • Demonstrated ability to identify, negotiate, and oversee outsourced services with vendors
  • Experience with financial budget planning and tracking.
  • High competence in common software and data analysis packages (eg, SoftMax Pro, GraphPad Prism, Microsoft Office, PowerPoint, Excel, Word). Knowledge of JMP a plus
  • Proven experience working in a bioanalytical laboratory environment is essential
  • Maintain current knowledge of the field and area(s) of scientific expertise and development
  • Data review, approval, analysis, graphing, reporting and presentation to internal and external audiences

 

Competencies and Attributes:

  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and core values – courageousness, creativity, selflessness and humor
  • Excellent organizational, documentation, and communication skills; critical thinking and the ability to work well in a team
  • Ability to lead and work with others in a positive and collaborative manner
  • Analytical and excellent problem-solving skills

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