Director, Cell Line Development

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. Position Summary:Horizon Therapeutics is looking for a highly motivated Scientific Director, Cell Line Development. The Scientific Director within Technical Operations will be involved with the full scope of the cell line development activities to support biologics development for FIH through commercial production needs. This is an integrated role, and the incumbent is expected to be excellent understanding in stable cell line, cell biology, molecule biology, biochemistry and cell based potency assay; to provide hands-on in planning, execution, and analysis of the studies; to make recommendation for the top clone selection for cell culture process and stable cell line for bioassay. The incumbent must work closely with the CROs and the business development team, to apply mammalian and microbial cell line development knowledge, ensuring the cell line readiness for biologics productions and cell-based bioassays to successfully advance biologics programs. The position will also support Horizon''s Business Development activities, will conduct CMC related due diligence, specifically provide expert''s opinion on but not limited to cell line, cell physiology, cell biology and/or other CMC related topicsResponsibilities:Design mammalian and microbial cell line development strategies to differentially meet the needs for fast-to-FIH and high-performing commercial production Develop cell line development plan and workflow in-house and/or collaboration with the CROs; responsible for cell engineering and characterization, and DNA constructs generation and construction; responsible to generate the stable CHO clones, evaluate clone performance, product quality, and recommend top clonesSupport the technology transfer, GMP cell bank manufacturing and characterization with the CDMOsWork with the discovery team to implement manufacturability thinking at the molecule design stageWork with the cell culture team to implement scalability thinking at cell line development stageWork with the bioassay team to identify/develop the bioassay cell line that meets the need for the targeted Mode of ActionParticipate in due diligence and business development activities as neededReview and interpret the data of cell line and process developments, and propose improvement plans when neededInterface with Quality, Engineering, Validation, Manufacturing, and Development; ensure cell line and/or cell bank meet quality standards and is acceptable for use in clinical and/or commercial manufacturing.Co-author and review cell line development sections of regulatory documentsContribute to publication strategy and content of individual publications, abstracts, and presentationsMaintain up-to-date knowledge of scientific published literatureQualifications and Skills Required:PhD Degree in Biological science, Biochemistry, Molecular Biology or Chemical/Biochemical Engineering related scientific field.Minimum 10+ years'' experience in appropriate cell line development and cell characterizationSolid understanding of relevant areas such as expression construct design, genetic manipulation, sequence variant identification, implementation of quality attributes in cell line selection, cell biology, and omics approaches to improve cell line and cell culture process developmentsExperienced in cell based or other relevant cell and molecular biology methodsBiopharmaceutical experience as a technical lead across therapeutic areas is desirableExperiences with process development is desirableExperiences in cGMP and technology transfer, such as document management, deviation root-cause analysis, CAPA and change control is desirableAbility to conduct experiments, analyze and summarize the data, and communicate the results both internally and externallyStrong track record as evidenced by scientific publicationsProfessional, proactive demeanorStrong interpersonal skillsExcellent 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 requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). ''Fully vaccinated'' is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law. 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.

Created: 2025-11-15