#Horizon therapeutics gaithersburg md professional

Trusting teach other and tackling tough challenges can make a powerful difference.Accountability: We do what's right for our patient communities through quality decisions and owning our successes and failures.Growth: We fiercely innovate and evolve to better ourselves, our communities and our patients.These three values come to life through our five Leadership Expectations that apply to all Horizon employeesEnterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspectiveExhibit Intellectual Curiosity: Seek to understand what you do not know ask the right questions of the right people and sourcesEnsure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitmentsEmbrace Diverse Perspectives: Welcome others with a respectful attitude integrate diverse perspectives into ways of workingDevelop Talent: Provide feedback, coaching and mentorship to help others be more effective in their roleAt Horizon, we know that disease does not discriminate. IND, NDA/BLA) and bioanalytical components of nonclinical and clinical study protocolStrong knowledge in GxP regulations and regulatory guidance documents that apply to bioanalysisLeadership experience in both project and people managementProficient in Microsoft OfficeProfessional, proactive demeanorStrong interpersonal skillsExcellent written and verbal communication skillsOur ValuesTransparency: We value collaboration. ELISA, ECL/MSD), LC-MS/MS, etc.Experience in preparing bioanalytical sections of regulatory submission (e.g. Leads efforts to generate and interpret data and communicate results internally and externallyBuilds strong relationships and networks externally as well as internally with therapeutic area leaders, facilitating strategic alignment and collaborations with partnersQualifications and Skills Required:PhD in biology, chemistry, biochemistry, biotechnology, or related field.10+ years of experience in the biopharmaceutical industry supporting bioanalysis in nonclinical and clinical programsPrevious experience managing CRO partners is a mustStrong scientific background and experience with the development and validation of PK, immunogenicity and biomarker assays for small and large molecule programsSubject matter expert in analytical platforms such as ligand-binding assays (e.g. pre-IND, IND, NDA, BLA) and address relevant queries from regulatory agenciesProjects company leadership in R&D by interacting with industry opinion leaders. Ensures alignment with project and organizational goals and objectivesAttract and retain key talent to build and maintain bioanalytical capabilities at HorizonDrive alignment with study teams, functional leadership, and governance committees on bioanalytical strategies and resourcing for Horizon's portfolioProvides oversight in the development and validation of bioanalytical methods, sample testing and troubleshooting at outsourced CROsContributes to the preparation of nonclinical and clinical study protocols, reports, and bioanalytical sections of regulatory submissions (e.g. This may be achieved as an individual contributor or by collaborating with different disciplines and across cross functional teamsDirects and manages the activities within the Bioanalytical Sciences group. Scientific expert who contributes to responses to questions from regulatory agency on bioassays and immunogenicity. Responsibilities:Leads the design, execution, and interpretation of bioanalytical assays as well as bioanalytical strategies for the organization.

#Horizon therapeutics gaithersburg md professional

We offer industry-leading and award-winning benefits, compensation and rewards programs that positively impact all areas of our employees' personal and professional lives. The exceptional support we provide patients and communities equally extends to our employees. Start a career that enables you to live up to your potential and help others live up to theirs. Our global biotechnology company is made up of agile, out-of-the-box thinkers with a focus on delivering breakthrough medicines to those living with rare, autoimmune, and severe inflammatory diseases. At Horizon Therapeutics, we define success by the number of lives touched, lives changed, and lives saved.