Sr Scientist, Analytical Sciences

Company: Horizon Therapeutics
Location: Silver Spring
Posted on: June 24, 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.

Summary

The Senior Scientist, Analytical Sciences is responsible for protein therapeutics development, qualification and transfer of methods that demonstrate the safety, purity and potency of molecules across the entire portfolio and through all stages of clinical development via release, characterization and stability testing.

Responsibilities

• Serve as the subject matter expert for molecule developability, product characterization, CQA assessment, method issues, including experiment design, data interpretation, and troubleshooting. Contribute to the investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results.
• Responsible for physical chemical method development, optimization, qualification, and transfer to CDMO and QC (Quality Control) laboratories for release testing clinical and commercial materials.
• Review characterization plan/reports, comparability protocol/reports, method SOPs, method development/transfer/qualification and validation protocols and reports.
• Preparation and review of CMC sections related to analytical procedures, method validation, comparability, specifications, reference standard and stability in INDs, IMPDs, MAAs, BLAs, and other regulatory submissions.
  • Support process development including upstream (cell line, cell bank, cell culture development), downstream (impurities analysis, in process testing), formulation group (formulation screening, compatibility) and later stage process characterizations. Support research group's molecules generations, validation, and potential new molecule nomination for clinical study.
  • Collaborate with QA to establish guidance and procedures. Support analytical laboratory harmonization across different sites and analytical method transfer internally. Support new laboratory capabilities establishment with purchase of new equipment and installation.
    
    Qualifications
    
    • BS. MS or PhD in Chemistry, Biology, Pharmaceutical Sciences or Life Sciences and related experience (BS 10 years, MS 8 years, PhD 4 years)
    • Significant in-depth technical expertise in analytical development and commercialization of biologics. Broad knowledge of protein chemistry and structural characterization of mAbs and novel biologics using biochemical and biological techniques.
    • Proven experience with late stage characterization, CQA assessment, control strategy, and marketing applications required.
    • Demonstrated expertise in methods including chromatography-based method (HIC, IEX, SEC), electrophoresis-based methods (cIEF, CE-SDS), mass spectrometry-based methods (peptide mapping, host cell protein analysis), and other excipients analysis such PS80, PS20, and Poloxamer 188.
    • Familiar with USP and EP guidelines, including appearance, particles, bioburden, endotoxin, sterility. Familiar with regulatory guidelines from ICH, FDA and EMA.
    • Experience in cGMP and QC practices including reference standard, stability, and validation. Experience in the successful transfer of methods to Quality functions within, and external to, the company.
    • Have the ability to effectively prioritize and manage a diversified workload, often to strict deadlines. You should have strong interpersonal skills, a professional approach with excellent w r i tten a nd v erbal c omm uni c ation s ki l ls.
    • Highly flexible as this is an agile, growing organization that needs to adapt quickly to new acquisitions and market demands.
    • Demonstrated technical proficiency, scientific creativity and innovation individually and in collaboration with others.
      
      Horizon 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.

Keywords: Horizon Therapeutics, Silver Spring , Sr Scientist, Analytical Sciences, Other , Silver Spring, Maryland