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Position:
Director, Bioanalytical Sciences

Employer:
Horizon Therapeutics

Description:
  • Leads the design, execution, and interpretation of bioanalytical assays as well as bioanalytical strategies for the organization. Scientific expert who contributes to responses to questions from regulatory agency on bioassays and immunogenicity. This may be achieved as an individual contributor or by collaborating with different disciplines and across cross functional teams
  • Directs and manages the activities within the Bioanalytical Sciences group. Ensures alignment with project and organizational goals and objectives
  • Attract and retain key talent to build and maintain bioanalytical capabilities at Horizon
  • Drive alignment with study teams, functional leadership, and governance committees on bioanalytical strategies and resourcing for Horizon’s portfolio
  • Provides oversight in the development and validation of bioanalytical methods, sample testing and troubleshooting at outsourced CROs
  • Contributes to the preparation of nonclinical and clinical study protocols, reports, and bioanalytical sections of regulatory submissions (e.g. pre-IND, IND, NDA, BLA) and address relevant queries from regulatory agencies
  • Projects company leadership in R&D by interacting with industry opinion leaders. Leads 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

Qualifications/Experience:
  • PhD in biology, chemistry, biochemistry, biotechnology, or related field.
  • 10+ years of experience in the biopharmaceutical industry supporting bioanalysis in nonclinical and clinical programs
  • Previous experience managing CRO partners is a must
  • Strong scientific background and experience with the development and validation of PK, immunogenicity and biomarker assays for small and large molecule programs
  • Subject matter expert in analytical platforms such as ligand-binding assays (e.g. ELISA, ECL/MSD), LC-MS/MS, etc.
  • Experience in preparing bioanalytical sections of regulatory submission (e.g. IND, NDA/BLA) and bioanalytical components of nonclinical and clinical study protocol
  • Strong knowledge in GxP regulations and regulatory guidance documents that apply to bioanalysis
  • Leadership experience in both project and people management
  • Proficient in Microsoft Office
  • Professional, proactive demeanor
  • Strong interpersonal skills
  • Excellent written and verbal communication skills

Location: South San Francisco, CA or Rockville, MD

Contact: https://horizon.wd1.myworkdayjobs.com/Horizon/job/South-San-Francisco-CA/Director--Bioanalytical-Sciences_R0004849

Post Date: 5/18/2023 11:21:32 AM
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