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Scientist II, Bioanalytical

Company: Horizon Therapeutics
Location: Bethesda
Posted on: June 19, 2022

Job Description:

Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs. Responsibilities:

  • Designs, executes, and interprets results of bioanalytical assays
  • Where necessary, develop solutions to and overcome issues with established methods
  • Prepare method procedures, qualification, and bioanalytical study reports
  • Assist with transfer of PK, ADA, and nAb assays to CROs for qualification/validation in a GxP environment
  • Involved in planning experimental design and execution of all aspects of preclinical and clinical bioanalysis including, de novo assay development, optimization, and troubleshooting of in vitro and cell-based assays
  • Current with industry thinking on bioanalytical approaches; and where possible present data at scientific conferences
  • Supports efforts to generate and interpret data and communicate results internally and externally
  • Builds strong relationships and networks externally as well as internally with therapeutic area leaders, facilitating strategic alignment and collaborations with partners
  • Maintains accurate and complete safety records consistent with company policy and legal requirements. Recognizes potential safety problems and takes action to rectify themQualifications and Skills Required:
    • MS or PhD in relevant life science discipline
    • 8+ (MS) or 2+ (PhD) years in the biopharmaceutical industry, preferably in large molecule drug development
    • 3+ years managing CROs
    • In depth experience in ligand binding assay development (e.g. ELISA, ECL/MSD)
    • Knowledge of assay development and validation, and understanding GXP requirements and ICH/regulatory guidance to support the regulatory approval process
    • Leadership experience in both project and people management
    • Authoring reports/presentations/communication bullet
    • Experience within a fast pace biotech environment
    • Proficient in Microsoft Office
    • Professional demeanor
    • Self-starter attitude
    • Strong interpersonal skills
    • Excellent written and verbal communication skillsHorizon Core Values & Competencies: Growth
      • Manages Ambiguity
      • Strategic Mindset
      • Demonstrates Self-awareness
      • Cultivates Innovation
      • Develops Talent Accountability
        • Drives Results
        • Ensures Accountability
        • Decision Quality Transparency
          • Courage
          • Collaboration
          • Instills Trust Horizon requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). "Fully vaccinated" is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law. Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.Required
            Preferred
            Job Industries
            • Customer Service

Keywords: Horizon Therapeutics, Bethesda , Scientist II, Bioanalytical, Other , Bethesda, Maryland

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