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:

• Provides guidance on 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.
• Supports the development, qualification, and validation/transfer of PK, ADA, and NAb assays to external CROs and acts as a point of contact with the CROs for sample testing. Experience with development of toxicokinetic/pharmacokinetic assays for siRNA is desirable.
• Involved in planning experimental design and execution of all aspects of preclinical and clinical bioanalysis, including de novo assay development, optimization, and troubleshooting
• Contributes to multidisciplinary, bioanalytical, regulatory, and clinical team meetings
• Maintains accurate and complete safety records consistent with company policy and legal requirements. Recognizes potential safety problems and takes action to rectify them

Qualifications and Skills Required:

• BS or MS in biology, chemistry, biochemistry, biotechnology, or related field.
• 4-5 years in the biopharmaceutical industry, preferably with 2+ years managing CROs.
• In depth experience in ligand binding assay development (e.g. ELISA, ECL/MSD) and/or LC-MS/MS.
• Knowledge of assay development and validation, as well as an understanding of GXP requirements and ICH guidelines to support the regulatory approval process.
• Strong organizational skills and project management experience.
• Ability to work independently and build open and collaborative relationships.
• Proficient in Microsoft Office.
• Professional, proactive demeanor.
• Strong interpersonal skills.

• Excellent written and verbal communication skills.

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 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. more