Place in the Organization uniQure is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working lives by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need. The Process Development (PD) department is part of uniQure s Operations organization. This department is responsible for the development of GMP manufacturing processes and analytical methods of our AAV-based gene therapy products. Analytical Development group in PD is responsible for the late stage assay development, qualification, method transfer to QC, assay validation support, assay remediation, as well as internal analytical testing support. This Associate Scientist position is located in Lexington, MA and reports to the Testing group lead within Analytical Development. This individual will provide analytical testing support, assist in method qualification and transfer, participate in daily lab maintenance. This individual may interact extensively with other groups within uniQure, including Upstream and Downstream teams in Process Development, early stage Analytical Development, Quality Control, Manufacturing, Engineering, QA and Regulatory Affair etc. Key result areas (major duties, accountabilities and responsibilities): Perform critical analytical assays to support PD studies, including HPLC, ELISA, Cell-based assay, SDS-PAGE, Western Blotting, and other requested assays.Participate in building up a new analytical lab and involve in daily lab management and maintenance.Assist in method qualification and transfer, support assay validation and assay trouble shooting.Interact with other groups within uniQure.Other duties, as assigned. Qualifications & Skills: B.S or M.S degree in Biochemistry, Biophysics, Analytical Chemistry or related disciplines with a minimum of 1-year relevant experience in biotech industry.Hands-on experience in analytical testing methods on biologics is required, experience in viral vaccines or gene therapy is a plus.Experience with method transfer to GMP labs, assay trouble shooting and process/product investigations is preferred. Core competencies: Strong communication skills, including writing and oral presentationsStrong technical and analytical skillsTake initiative, being willing to work in a fast-paced environment with demonstrated capacity to handle multiple tasks and demandsPro-active attitude, flexible, professional, independent and a team player Associated topics: biopharma, clinical, cytometry, drug, food, health, immuno oncology, immunology, medicine, microbiological
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