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Director, Bioanalytical Sciences
Horizon Therapeutics

South San Francisco, California

Open rank Professor of Pharmaceutics/Industrial Pharmacy
Western New England University

Springfield, Massachusetts

Faculty Pharmaceutical Sciences
Massachusetts College of Pharmacy and Health Sciences

Worcester, Massachusetts

Post Doctoral Associate Pharm-Pharmaceutical Science
University of Pittsburgh/MWRI

Pittsburgh, Pennsylvania

Faculty Professor Research Assistant - Full-Time
University of Pittsburgh/MWRI

Pittsburgh, Pennsylvania

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Director, Bioanalytical Sciences
Horizon Therapeutics
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Details

Posted: 18-May-23

Location: South San Francisco, California

Type: Full Time

Salary: 193,500-236,500

Categories:

Academic / Research

Salary Details:

25% Target Bonus Equity

Required Education:

Doctorate

Internal Number: R0004849

  • 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

  • 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

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About Horizon Therapeutics
Horizon is focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: We apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives.
Connections working at Horizon Therapeutics
https://careers.aaps.org/jobs/18600483/director-bioanalytical-sciences