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.
Horizon is searching for a highly motivated individual with a strong background in HPLC method development/transfer and protein characterization to join our Analytical Sciences Department. You will support CMC activities for our growing pipeline of medicines for patients.
Key Responsibilities:
Work in a dynamic, matrix team to support analytical development, manufacturing process development, and formulation development. Use chromatography, and/or other separation and biophysical techniques to support product and impurity characterizations, as well as structure/function studies. Set up new lab and procedures. Maintain and troubleshoot instruments. Train other analysts and troubleshoot methods. Develop, optimize, qualify, and transfer lot release assays to QC (Quality Control) laboratories and CDMOs. Work with CDMO to set specifications, create stability protocols, and monitor stability programs. Generate experimental protocols and documentation; perform experiments, data analysis and interpretation; report results within the department and at the cross-functional level; review and summarize data generated from internal labs and CDMOs. Represent Analytical function in CMC teams. Author technical reports and relevant sections of regulatory filings (e.g., INDs, IMPDs, BLAs).
Qualifications and Skills Required:
Educational requirements include a degree in Chemistry, Biochemistry, Chemical Engineering or related fields: PhD with 1-5 years, or MS with 5-10 years, or BS with 8-12 years of experience in the biopharmaceutical industry. Knowledge of protein chemistry, purification, degradation pathways, and chromatography methods involved in characterization of proteins, excipients, and impurities. Extensive experience with HPLC method development/qualification/transfer. Expert on instrument setup, maintenance and troubleshooting, including various detectors (such as UV, Fluorescence, ELSD, CAD, RI, MALS, Mass Spec) and fraction collectors. Familiar with HPLC software such as Openlab, Empower 3, and Chromeleon. Working knowledge on 2D-LC systems, nano-LC, CE-SDS, or Biacore is a plus. Demonstrated ability in creative problem solving and application of scientific principles. Attention to detail, self-motivated, and ability to set priorities. Strong verbal and written communication skills both within the organization as well as externally. Strong technical writing skills: preparation of protocols, reports, SOPs, etc. Good multi-tasking, time management and organizational skills are essential. Programing skills for data analysis, organization, and trending. Experience in cGMP practices, CMC, regulatory filings, and IP strategies preferred.
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.